Ignite Creation Date:
2025-12-24 @ 11:02 PM
Ignite Modification Date:
2026-01-03 @ 10:22 PM
Study NCT ID:
NCT02995369
Status:
COMPLETED
Last Update Posted:
2023-01-20
First Post:
2016-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
DryShield vs Cotton Roll Isolation During Sealants Placement: Efficiency and Patient Preference
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057240', 'term': 'Patient Preference'}], 'ancestors': [{'id': 'D017060', 'term': 'Patient Satisfaction'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nkakanan@montefiore.org', 'phone': '718-405-8057', 'title': 'Nuntiya Kakanantadilok', 'organization': 'Montefiore Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'During Dental sealant appointment (average about 30 minutes)', 'description': 'Adverse events were summarized/categorized for the four Arms/Groups based on the sequence the interventions were placed.', 'eventGroups': [{'id': 'EG000', 'title': 'Cotton Roll Isolation (Left)', 'description': 'Cotton rolls (CRI) were used to isolate the maxillary and mandibular teeth on the left side of the mouth, followed by sealants placement using Dryshield (DS) on the opposite side.\n\nCotton rolls: Cotton Roll Isolation requires placing cotton rolls along the buccal mucosa, especially over the parotid glands ducts for maxillary teeth. For the mandibular teeth, the cotton rolls are placed in the buccal vestibule and the floor of the mouth (between the lower buccal mucosa and underneath and/or between the tongue). With this technique, a high-speed evacuation of saliva and water was used.\n\nDryshield: DryShield (DS) is an all-in-one isolation system. It combines the tasks of fluid evacuation, tongue and cheek retraction, and serves as a bite block. Its design allows it to suction and isolate half the oral cavity at a time.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cotton Roll Isolation (Right)', 'description': 'Cotton rolls (CRI) were used to isolate the maxillary and mandibular teeth on the right side of the mouth, followed by sealants placement using Dryshield (DS) on the opposite side.\n\nCotton rolls: Cotton Roll Isolation requires placing cotton rolls along the buccal mucosa, especially over the parotid glands ducts for maxillary teeth. For the mandibular teeth, the cotton rolls are placed in the buccal vestibule and the floor of the mouth (between the lower buccal mucosa and underneath and/or between the tongue). With this technique, a high-speed evacuation of saliva and water is used.\n\nDryshield: DryShield (DS) is an all-in-one isolation system. It combines the tasks of fluid evacuation, tongue and cheek retraction, and serves as a bite block. Its design allows it to suction and isolate half the oral cavity at a time.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Dryshield Isolation (Left)', 'description': 'Dryshield (DS) was used to isolate the maxillary and mandibular teeth on the left side of the mouth, followed by sealants placement using cotton rolls (CRI) on the opposite side.\n\nDryshield: DryShield (DS) is an all-in-one isolation system. It combines the tasks of fluid evacuation, tongue and cheek retraction, and serves as a bite block. Its design allows it to suction and isolate half the oral cavity at a time.\n\nCotton rolls: Cotton Roll Isolation requires placing cotton rolls along the buccal mucosa, especially over the parotid glands ducts for maxillary teeth. For the mandibular teeth, the cotton rolls are placed in the buccal vestibule and the floor of the mouth (between the lower buccal mucosa and underneath and/or between the tongue). With this technique, a high-speed evacuation of saliva and water was used.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Dryshield Isolation (Right)', 'description': 'Dryshield (DS) was used to isolate the maxillary and mandibular teeth on the right side of the mouth, followed by sealants placement using cotton rolls (CRI) on the opposite side.\n\nDryshield: DryShield (DS) is an all-in-one isolation system. It combines the tasks of fluid evacuation, tongue and cheek retraction, and serves as a bite block. Its design allows it to suction and isolate half the oral cavity at a time\n\nCotton rolls: Cotton Roll Isolation requires placing cotton rolls along the buccal mucosa, especially over the parotid glands ducts for maxillary teeth. For the mandibular teeth, the cotton rolls are placed in the buccal vestibule and the floor of the mouth (between the lower buccal mucosa and underneath and/or between the tongue). With this technique, a high-speed evacuation of saliva and water was used.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Placement Time of Sealants Using Dryshield (DS) vs Cotton Rolls (CRI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cotton Roll Isolation (Left)', 'description': 'Cotton rolls (CRI) were used to isolate the maxillary and mandibular teeth on the left side of the mouth, followed by sealants placement using Dryshield (DS) on the opposite side.\n\nCotton rolls: Cotton Roll Isolation requires placing cotton rolls along the buccal mucosa, especially over the parotid glands ducts for maxillary teeth. For the mandibular teeth, the cotton rolls are placed in the buccal vestibule and the floor of the mouth (between the lower buccal mucosa and underneath and/or between the tongue). With this technique, a high-speed evacuation of saliva and water was used.\n\nDryshield: DryShield (DS) is an all-in-one isolation system. It combines the tasks of fluid evacuation, tongue and cheek retraction, and serves as a bite block. Its design allows it to suction and isolate half the oral cavity at a time.'}, {'id': 'OG001', 'title': 'Cotton Roll Isolation (Right)', 'description': 'Cotton rolls (CRI) were used to isolate the maxillary and mandibular teeth on the right side of the mouth, followed by sealants placement using Dryshield (DS) on the opposite side.\n\nCotton rolls: Cotton Roll Isolation requires placing cotton rolls along the buccal mucosa, especially over the parotid glands ducts for maxillary teeth. For the mandibular teeth, the cotton rolls are placed in the buccal vestibule and the floor of the mouth (between the lower buccal mucosa and underneath and/or between the tongue). With this technique, a high-speed evacuation of saliva and water was used.\n\nDryshield: DryShield (DS) is an all-in-one isolation system. It combines the tasks of fluid evacuation, tongue and cheek retraction, and serves as a bite block. Its design allows it to suction and isolate half the oral cavity at a time.'}, {'id': 'OG002', 'title': 'Dryshield Isolation (Left)', 'description': 'Dryshield (DS) was used to isolate the maxillary and mandibular teeth on the left side of the mouth, followed by sealants placement using cotton rolls (CRI) on the opposite side.\n\nDryshield: DryShield (DS) is an all-in-one isolation system. It combines the tasks of fluid evacuation, tongue and cheek retraction, and serves as a bite block. Its design allows it to suction and isolate half the oral cavity at a time.\n\nCotton rolls: Cotton Roll Isolation requires placing cotton rolls along the buccal mucosa, especially over the parotid glands ducts for maxillary teeth. For the mandibular teeth, the cotton rolls are placed in the buccal vestibule and the floor of the mouth (between the lower buccal mucosa and underneath and/or between the tongue). With this technique, a high-speed evacuation of saliva and water was used.'}, {'id': 'OG003', 'title': 'Dryshield Isolation (Right)', 'description': 'Dryshield (DS) was used to isolate the maxillary and mandibular teeth on the right side of the mouth, followed by sealants placement using cotton rolls (CRI) on the opposite side.\n\nDryshield: DryShield (DS) is an all-in-one isolation system. It combines the tasks of fluid evacuation, tongue and cheek retraction, and serves as a bite block. Its design allows it to suction and isolate half the oral cavity at a time.\n\nCotton rolls: Cotton Roll Isolation requires placing cotton rolls along the buccal mucosa, especially over the parotid glands ducts for maxillary teeth. For the mandibular teeth, the cotton rolls are placed in the buccal vestibule and the floor of the mouth (between the lower buccal mucosa and underneath and/or between the tongue). With this technique, a high-speed evacuation of saliva and water was used.'}], 'classes': [{'categories': [{'measurements': [{'value': '164.88', 'spread': '28.78', 'groupId': 'OG000'}, {'value': '160.50', 'spread': '26.00', 'groupId': 'OG001'}, {'value': '164.56', 'spread': '27.72', 'groupId': 'OG002'}, {'value': '167.81', 'spread': '28.92', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Initial insertion of isolation aid (CRI or DS) and removal of corresponding isolation aid (CRI or DS)', 'description': 'The time for sealant application was recorded with a stopwatch by the dental assistant as follows for the techniques: the insertion of the first isolation aid (CRI or DS) in the oral cavity constituted the start time, and the end time was when the corresponding isolation aid (CRI or DS) was removed from the oral cavity after the sealants application.', 'unitOfMeasure': 'Seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Results were analyzed and reported based on the sequence the interventions were administered.'}, {'type': 'PRIMARY', 'title': 'Patient Preference as Assessed by Verbal Self-report Survey', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cotton Roll Isolation (Left) First, Then Dryshield Isolation (Right)', 'description': 'Cotton rolls (CRI) were used to isolate the maxillary and mandibular teeth on the left side of the mouth, followed by sealants placement using Dryshield (DS) on the opposite side.\n\nThe four groups are a result of randomizing the side receiving one of the interventions (CRI v. DS) as well as the order of application (first v. second) resulting in a 1:1:1:1 randomization ratio with each patient acting as their own control.'}, {'id': 'OG001', 'title': 'Cotton Roll Isolation (Right) First, Then Dryshield Isolation (Left)', 'description': 'Cotton rolls (CRI) were used to isolate the maxillary and mandibular teeth on the right side of the mouth, followed by sealants placement using Dryshield (DS) on the opposite side.\n\nThe four groups are a result of randomizing the side receiving one of the interventions (CRI v. DS) as well as the order of application (first v. second) resulting in a 1:1:1:1 randomization ratio with each patient acting as their own control.'}, {'id': 'OG002', 'title': 'Dryshield Isolation (Left) First, Then Cotton Roll Isolation (Right)', 'description': 'Dryshield (DS) was used to isolate the maxillary and mandibular teeth on the left side of the mouth, followed by sealants placement using cotton rolls (CRI) on the opposite side.\n\nThe four groups are a result of randomizing the side receiving one of the interventions (CRI v. DS) as well as the order of application (first v. second) resulting in a 1:1:1:1 randomization ratio with each patient acting as their own control.'}, {'id': 'OG003', 'title': 'Dryshield Isolation (Right) First, Then Cotton Roll Isolation (Left)', 'description': 'Dryshield (DS) was used to isolate the maxillary and mandibular teeth on the right side of the mouth, followed by sealants placement using cotton rolls (CRI) on the opposite side.\n\nThe four groups are a result of randomizing the side receiving one of the interventions (CRI v. DS) as well as the order of application (first v. second) resulting in a 1:1:1:1 randomization ratio with each patient acting as their own control.'}], 'classes': [{'categories': [{'title': 'Cotton Roll Isolation (CRI)', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Dryshield (DS)', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Immediately after the dental procedure is completed, up to 30 minutes', 'description': 'Right after the procedure, participants completed a verbal survey. The survey consisted of seven closed-ended questions intended to assess the participants\' opinion on things such as comfort, noise, taste, and tissue stretching. Some survey questions require a YES or NO answer (i.e. Did you taste any of the materials used?). Other questions required the participant to select CRI or DS (i.e. Which system was the most comfortable?). The pediatric dental attending asked each patient each question, in the same sequence.\n\nPatient preferences were assessed with Question number 4, which specifically asked " If we did the procedure again, which system would you prefer?" The options were the Cotton Roll Isolation (CRI) or the Dryshield (DS) system. The reported values represents the response to Question number 4.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All 32 participants who were enrolled into the study were queried for their preference (CRI vs DS). Only 8 participants per group analyzed (instead of 16 as in the other Primary Outcome Measure) as the survey was only administered once per participant.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cotton Roll Isolation (Left) First, Then Dryshield Isolation (Right)', 'description': 'Group (1) Cotton rolls (CRI) were used to isolate the maxillary and mandibular teeth on the left side of the mouth, followed by sealants placement using Dryshield (DS) on the right side.\n\nCotton rolls: Cotton Roll Isolation requires placing cotton rolls along the buccal mucosa, especially over the parotid glands ducts for maxillary teeth. For the mandibular teeth, the cotton rolls are placed in the buccal vestibule and the floor of the mouth (between the lower buccal mucosa and underneath and/or between the tongue). With this technique, a high-speed evacuation of saliva and water was used.\n\nDryshield: DryShield (DS) is an all-in-one isolation system. It combines the tasks of fluid evacuation, tongue and cheek retraction, and serves as a bite block. Its design allows it to suction and isolate half the oral cavity at a time.\n\nThe four arms/groups are a result of randomizing the side receiving one of the interventions (CRI v. DS) as well as the order of application (first v. second) resulting in a 1:1:1:1 randomization ratio with each patient acting as their own control.'}, {'id': 'FG001', 'title': 'Cotton Roll Isolation (Right) First, Then Dryshield Isolation (Left)', 'description': 'Group (2) Cotton rolls (CRI) were used to isolate the maxillary and mandibular teeth on the right side of the mouth, followed by sealants placement using Dryshield (DS) on the left side.\n\nCotton rolls: Cotton Roll Isolation requires placing cotton rolls along the buccal mucosa, especially over the parotid glands ducts for maxillary teeth. For the mandibular teeth, the cotton rolls are placed in the buccal vestibule and the floor of the mouth (between the lower buccal mucosa and underneath and/or between the tongue). With this technique, a high-speed evacuation of saliva and water was used.\n\nDryshield: DryShield (DS) is an all-in-one isolation system. It combines the tasks of fluid evacuation, tongue and cheek retraction, and serves as a bite block. Its design allows it to suction and isolate half the oral cavity at a time.\n\nThe four groups are a result of randomizing the side receiving one of the interventions (CRI v. DS) as well as the order of application (first v. second) resulting in a 1:1:1:1 randomization ratio with each patient acting as their own control.'}, {'id': 'FG002', 'title': 'Dryshield Isolation (Left) First, Then Cotton Roll Isolation (Right)', 'description': 'Group (3) Dryshield (DS) was used to isolate the maxillary and mandibular teeth on the left side of the mouth, followed by sealants placement using cotton rolls (CRI) on the right side.\n\nDryshield: DryShield (DS) is an all-in-one isolation system. It combines the tasks of fluid evacuation, tongue and cheek retraction, and serves as a bite block. Its design allows it to suction and isolate half the oral cavity at a time.\n\nCotton rolls: Cotton Roll Isolation requires placing cotton rolls along the buccal mucosa, especially over the parotid glands ducts for maxillary teeth. For the mandibular teeth, the cotton rolls are placed in the buccal vestibule and the floor of the mouth (between the lower buccal mucosa and underneath and/or between the tongue). With this technique, a high-speed evacuation of saliva and water was used.\n\nThe four groups are a result of randomizing the side receiving one of the interventions (CRI v. DS) as well as the order of application (first v. second) resulting in a 1:1:1:1 randomization ratio with each patient acting as their own control.'}, {'id': 'FG003', 'title': 'Dryshield Isolation (Right) First, Then Cotton Roll Isolation (Left)', 'description': 'Group (4) Dryshield (DS) was used to isolate the maxillary and mandibular teeth on the right side of the mouth, followed by sealants placement using cotton rolls (CRI) on the left side.\n\nDryshield: DryShield (DS) is an all-in-one isolation system. It combines the tasks of fluid evacuation, tongue and cheek retraction, and serves as a bite block. Its design allows it to suction and isolate half the oral cavity at a time.\n\nCotton rolls: Cotton Roll Isolation requires placing cotton rolls along the buccal mucosa, especially over the parotid glands ducts for maxillary teeth. For the mandibular teeth, the cotton rolls are placed in the buccal vestibule and the floor of the mouth (between the lower buccal mucosa and underneath and/or between the tongue). With this technique, a high-speed evacuation of saliva and water was used.\n\nThe four groups are a result of randomizing the side receiving one of the interventions (CRI v. DS) as well as the order of application (first v. second) resulting in a 1:1:1:1 randomization ratio with each patient acting as their own control.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Study participants were selected from pediatric patients who presented to one of the four Montefiore pediatric dental clinics for an intake or a recall visit and who were determined to benefit from sealants application, or from patients who present solely for a sealant application appointment, when their examination was done at a previous date (within 6 months).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '32', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Cotton Roll Isolation (Left) First, Then Dryshield Isolation (Right)', 'description': 'Group (1) Cotton rolls (CRI) were used to isolate the maxillary and mandibular teeth on the left side of the mouth, followed by sealants placement using Dryshield (DS) on the right side.\n\nThe four arms/groups are a result of randomizing the side receiving one of the interventions (CRI v. DS) as well as the order of application (first v. second) resulting in a 1:1:1:1 randomization ratio with each patient acting as their own control.'}, {'id': 'BG001', 'title': 'Cotton Roll Isolation (Right) First, Then Dryshield Isolation (Left)', 'description': 'Group (2) Cotton rolls (CRI) were used to isolate the maxillary and mandibular teeth on the right side of the mouth, followed by sealants placement using Dryshield (DS) on the left side.\n\nThe four arms/groups are a result of randomizing the side receiving one of the interventions (CRI v. DS) as well as the order of application (first v. second) resulting in a 1:1:1:1 randomization ratio with each patient acting as their own control.'}, {'id': 'BG002', 'title': 'Dryshield Isolation (Left) First, Then Cotton Roll Isolation (Right)', 'description': 'Group (3) Dryshield (DS) was used to isolate the maxillary and mandibular teeth on the left side of the mouth, followed by sealants placement using cotton rolls (CRI) on the right side.\n\nThe four arms/groups are a result of randomizing the side receiving one of the interventions (CRI v. DS) as well as the order of application (first v. second) resulting in a 1:1:1:1 randomization ratio with each patient acting as their own control.'}, {'id': 'BG003', 'title': 'Dyshield Isolation (Right) First, Then Cotton Roll Isolation (Left)', 'description': 'Group (4) Dryshield (DS) was be used to isolate the maxillary and mandibular teeth on the right side of the mouth, followed by sealants placement using cotton rolls (CRI) on the left side.\n\nThe four arms/groups are a result of randomizing the side receiving one of the interventions (CRI v. DS) as well as the order of application (first v. second) resulting in a 1:1:1:1 randomization ratio with each patient acting as their own control.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '32', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '8.6', 'groupId': 'BG000', 'lowerLimit': '7', 'upperLimit': '10'}, {'value': '8.6', 'groupId': 'BG001', 'lowerLimit': '6', 'upperLimit': '11'}, {'value': '8.8', 'groupId': 'BG002', 'lowerLimit': '6', 'upperLimit': '13'}, {'value': '8.5', 'groupId': 'BG003', 'lowerLimit': '6', 'upperLimit': '12'}, {'value': '8.6', 'groupId': 'BG004', 'lowerLimit': '6', 'upperLimit': '13'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '32', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '32', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Forms used to extract study-related data from patient files did not capture gender/sex. The forms were de-identified so it was not possible to track back to the original patient records to retrieve gender/sex data.', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '32', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '32', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-01-17', 'size': 604358, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-12-19T16:13', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2017-03-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-29', 'studyFirstSubmitDate': '2016-12-14', 'resultsFirstSubmitDate': '2019-01-03', 'studyFirstSubmitQcDate': '2016-12-15', 'lastUpdatePostDateStruct': {'date': '2023-01-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-12-29', 'studyFirstPostDateStruct': {'date': '2016-12-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-03-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Placement Time of Sealants Using Dryshield (DS) vs Cotton Rolls (CRI)', 'timeFrame': 'Initial insertion of isolation aid (CRI or DS) and removal of corresponding isolation aid (CRI or DS)', 'description': 'The time for sealant application was recorded with a stopwatch by the dental assistant as follows for the techniques: the insertion of the first isolation aid (CRI or DS) in the oral cavity constituted the start time, and the end time was when the corresponding isolation aid (CRI or DS) was removed from the oral cavity after the sealants application.'}, {'measure': 'Patient Preference as Assessed by Verbal Self-report Survey', 'timeFrame': 'Immediately after the dental procedure is completed, up to 30 minutes', 'description': 'Right after the procedure, participants completed a verbal survey. The survey consisted of seven closed-ended questions intended to assess the participants\' opinion on things such as comfort, noise, taste, and tissue stretching. Some survey questions require a YES or NO answer (i.e. Did you taste any of the materials used?). Other questions required the participant to select CRI or DS (i.e. Which system was the most comfortable?). The pediatric dental attending asked each patient each question, in the same sequence.\n\nPatient preferences were assessed with Question number 4, which specifically asked " If we did the procedure again, which system would you prefer?" The options were the Cotton Roll Isolation (CRI) or the Dryshield (DS) system. The reported values represents the response to Question number 4.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Sealants', 'Dryshield', 'Cotton roll', 'Isolation', 'Efficiency', 'Preference'], 'conditions': ['Time', 'Patient Preference']}, 'referencesModule': {'references': [{'pmid': '20483019', 'type': 'BACKGROUND', 'citation': 'Collette J, Wilson S, Sullivan D. A study of the Isolite system during sealant placement: efficacy and patient acceptance. Pediatr Dent. 2010 Mar-Apr;32(2):146-50.'}, {'pmid': '25303507', 'type': 'BACKGROUND', 'citation': 'Alhareky MS, Mermelstein D, Finkelman M, Alhumaid J, Loo C. Efficiency and patient satisfaction with the Isolite system versus rubber dam for sealant placement in pediatric patients. Pediatr Dent. 2014 Sep-Oct;36(5):400-4.'}, {'pmid': '18310730', 'type': 'BACKGROUND', 'citation': 'Beauchamp J, Caufield PW, Crall JJ, Donly K, Feigal R, Gooch B, Ismail A, Kohn W, Siegal M, Simonsen R; American Dental Association Council on Scientific Affairs. Evidence-based clinical recommendations for the use of pit-and-fissure sealants: a report of the American Dental Association Council on Scientific Affairs. J Am Dent Assoc. 2008 Mar;139(3):257-68. doi: 10.14219/jada.archive.2008.0155.'}, {'pmid': '23756302', 'type': 'BACKGROUND', 'citation': 'Lyman T, Viswanathan K, McWhorter A. Isolite vs cotton roll isolation in the placement of dental sealants. Pediatr Dent. 2013 May-Jun;35(3):E95-9.'}, {'pmid': '11680361', 'type': 'BACKGROUND', 'citation': 'Primosch RE, Barr ES. Sealant use and placement techniques among pediatric dentists. J Am Dent Assoc. 2001 Oct;132(10):1442-51; quiz 1461. doi: 10.14219/jada.archive.2001.0061.'}]}, 'descriptionModule': {'briefSummary': 'The goals of this study are to determine if 1) placement times of pit and fissure sealants using the DryShield system differ from those when using the cotton roll isolation technique; and 2) there is a significant difference in patient preference between Dryshield and the cotton roll technique.', 'detailedDescription': "Pit and fissure caries account for 80 to 90 percent of all caries in permanent posterior teeth. Pit-and-fissure sealants can be used effectively to prevent caries. By micromechanically bonding to the teeth, they provide a physical barrier that keeps microorganisms and food particles from collecting in susceptible pits and fissures, thus preventing caries initiation and arresting caries progression. The effectiveness of sealants for caries prevention depends on long-term retention, which is largely a function of meticulousness of application: keeping the tooth surface free from saliva contamination during application and polymerization is critical. Low retention of sealants has been attributed to insufficient moisture control. Therefore, proper isolation of the teeth is one of the most important steps when placing sealants to ensure their retention. Cotton roll isolation (CRI) has been widely used for sealant placement, and is the most common method among pediatric dentists. Although very effective, CRI can be a challenging technique especially when used in young children: the cotton rolls can be cumbersome for both the patient and the clinician. A previous study demonstrated that new moisture control systems such as Isolite, produce sealant retention rates comparable to cotton roll isolation, while decreasing procedure time. DryShield (DS) has recently been introduced as an all-in-one isolation system. It is similar to the Isolite as it combines the tasks of fluid evacuation, tongue and cheek retraction, and serves as a bite block, but differs in that it's autoclavable and does not provide illumination. Its design allows it to suction and isolate half the oral cavity at a time. Therefore, it should presumably facilitate sealants placement under a more controlled environment, while reducing chair time for the dentist.\n\nThe goals of this study are to determine if 1) placement times of pit and fissure sealants using the DryShield system differ from those when using the cotton roll isolation technique; and 2) there is a significant difference in patient preference between DryShield and the cotton roll technique."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'The target population will include healthy, cognitively normal patients who present to one of the Montefiore pediatric dental clinics for an intake or a recall visit who are determined to benefit from sealants application, or patients who present solely for a sealant application appointment, when their examination was completed at a previous date (within 6 months).\n\nInclusion Criteria:\n\n* American Society of Anesthesiologist (ASA) Classification I or II\n* Ages 5 to 14 years\n* Cooperative behavior at present visit or recorded at the previous encounter (classified as 3 or 4 on the Frankl Behavioral Rating Scale).\n* At least one erupted caries-free permanent molar in each quadrant\n* Ability able to speak and understand English or Spanish\n* There will be no exclusions based on race, gender, and ethnicity.\n\nExclusion Criteria:\n\n* ASA Classification III or higher\n* Uncooperative behavior at present visit or recorded at the previous encounter (classified as 1 or 2 on the Frankl Behavioral Rating Scale).\n* Patients who require less than four sealants on permanent molars\n* Patients who do not provide assent or consent.'}, 'identificationModule': {'nctId': 'NCT02995369', 'briefTitle': 'DryShield vs Cotton Roll Isolation During Sealants Placement: Efficiency and Patient Preference', 'organization': {'class': 'OTHER', 'fullName': 'Montefiore Medical Center'}, 'officialTitle': 'DryShield vs Cotton Roll Isolation During Sealants Placement: Efficiency and Patient', 'orgStudyIdInfo': {'id': '2016-7229'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cotton Roll Isolation (left), then DryShield Isolation (right)', 'description': 'Cotton rolls (CRI) will be used to isolate the maxillary and mandibular teeth on the left side of the mouth, followed by sealants placement using Dryshield (DS) on the opposite side.\n\nThe four groups are a result of randomizing the side receiving one of the interventions (CRI v. DS) as well as the order of application (first v. second).', 'interventionNames': ['Device: DryShield', 'Other: Cotton rolls']}, {'type': 'EXPERIMENTAL', 'label': 'Cotton Roll Isolation (right), then DryShield Isolation (left)', 'description': 'Cotton rolls (CRI) will be used to isolate the maxillary and mandibular teeth on the right side of the mouth, followed by sealants placement using DryShield (DS) on the opposite side.\n\nThe four groups are a result of randomizing the side receiving one of the interventions (CRI v. DS) as well as the order of application (first v. second).', 'interventionNames': ['Device: DryShield', 'Other: Cotton rolls']}, {'type': 'EXPERIMENTAL', 'label': 'DryShield Isolation (left), then Cotton Roll Isolation (right)', 'description': 'DryShield (DS) will be used to isolate the maxillary and mandibular teeth on the left side of the mouth, followed by sealants placement using cotton rolls (CRI) on the opposite side.\n\nThe four groups are a result of randomizing the side receiving one of the interventions (CRI v. DS) as well as the order of application (first v. second).', 'interventionNames': ['Device: DryShield', 'Other: Cotton rolls']}, {'type': 'EXPERIMENTAL', 'label': 'DryShield Isolation (right), then Cotton Roll Isolation (left)', 'description': 'DryShield (DS) will be used to isolate the maxillary and mandibular teeth on the right side of the mouth, followed by sealants placement using cotton rolls (CRI) on the opposite side.\n\nThe four groups are a result of randomizing the side receiving one of the interventions (CRI v. DS) as well as the order of application (first v. second).', 'interventionNames': ['Device: DryShield', 'Other: Cotton rolls']}], 'interventions': [{'name': 'DryShield', 'type': 'DEVICE', 'description': 'DryShield (DS) is an all-in-one isolation system. It combines the tasks of fluid evacuation, tongue and cheek retraction, and serves as a bite block. Its design allows it to suction and isolate half the oral cavity at a time.', 'armGroupLabels': ['Cotton Roll Isolation (left), then DryShield Isolation (right)', 'Cotton Roll Isolation (right), then DryShield Isolation (left)', 'DryShield Isolation (left), then Cotton Roll Isolation (right)', 'DryShield Isolation (right), then Cotton Roll Isolation (left)']}, {'name': 'Cotton rolls', 'type': 'OTHER', 'description': 'Cotton Roll Isolation requires placing cotton rolls along the buccal mucosa, especially over the parotid glands ducts for maxillary teeth. For the mandibular teeth, the cotton rolls are placed in the buccal vestibule and the floor of the mouth (between the lower buccal mucosa and underneath and/or between the tongue). With this technique, a high-speed evacuation of saliva and water is used.', 'armGroupLabels': ['Cotton Roll Isolation (left), then DryShield Isolation (right)', 'Cotton Roll Isolation (right), then DryShield Isolation (left)', 'DryShield Isolation (left), then Cotton Roll Isolation (right)', 'DryShield Isolation (right), then Cotton Roll Isolation (left)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}], 'overallOfficials': [{'name': 'Nuntiya Kakanantadilok, DMD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Montefiore Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Montefiore Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director Division of Pediatric Dentistry', 'investigatorFullName': 'Nuntiya Kakanantadilok', 'investigatorAffiliation': 'Montefiore Medical Center'}}}}