Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-26 @ 2:10 AM
Study NCT ID:
NCT06122805
Status:
RECRUITING
Last Update Posted:
2024-05-13
First Post:
2023-11-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of Dual Light Electric Toothbrush vs. Manual Toothbrush in Orthodontic Patients Undergoing Oral Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005891', 'term': 'Gingivitis'}, {'id': 'D002971', 'term': 'Cleft Lip'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D005882', 'term': 'Gingival Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D008047', 'term': 'Lip Diseases'}, {'id': 'D009056', 'term': 'Mouth Abnormalities'}, {'id': 'D018640', 'term': 'Stomatognathic System Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': 'randomized assignment of study ID number'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 198}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2027-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-09', 'studyFirstSubmitDate': '2023-11-03', 'studyFirstSubmitQcDate': '2023-11-03', 'lastUpdatePostDateStruct': {'date': '2024-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Löe and Silness Gingival Index', 'timeFrame': '18 weeks, 6 weeks apart evaluations', 'description': 'This involves a two-step process: Step One (1): evaluation of the clinical appearance of the gingival tissue; and Step Two (2): assessment of inflammation based on induction of bleeding from probing11. Step One will not be accomplished chairside but will be measured using photographs; Step Two will be done chairside.'}, {'measure': 'Bleeding index', 'timeFrame': '18 weeks, 6 weeks apart evaluations', 'description': 'For Bleeding Index (Appendix IIC) and measurement of Probing Depth, the scorers will be calibrated following the Examiner Guide to Measuring Periodontal Parameters \\& Indices11. Probing Depth will be measured using a University of North Carolina (UNC) #15 manual probe and a #5 mouth mirror'}], 'secondaryOutcomes': [{'measure': 'Turesky et al Modified Quigley-Hein Plaque Index and Modified Plaque Index for Orthodontic Patient', 'timeFrame': '18 weeks, 6 week apart evaluations', 'description': 'After placement of five drops of Trace® plaque disclosing liquid under the tongue, the participant will swish the solution for 30 seconds. Upon expectoration, the participant will rinse his/her mouth with water three times. Immediately, intraoral photographs will be made. All photos for Gingival Index and Plaque Index will be scored by two blinded scorers with inter-rater reliability calculated. All scoring data will be assessed by statistician.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Toothbrushing', 'Gingivitis', 'Cleft Lip and Palate']}, 'referencesModule': {'references': [{'pmid': '26665291', 'type': 'BACKGROUND', 'citation': 'Ccahuana-Vasquez RA, Conde E, Grender JM, Cunningham P, Qaqish J, Goyal CR. An Eight-Week Clinical Evaluation of an Oscillating-Rotating Power Toothbrush with a Brush Head Utilizing Angled Bristles Compared with a Sonic Toothbrush in the Reduction of Gingivitis and Plaque. J Clin Dent. 2015;26(3):80-5.'}]}, 'descriptionModule': {'briefSummary': 'The study is a randomized clinical trial to compare the effectiveness of a dual light ultrasonic toothbrush on periodontal health in orthodontic patients undergoing surgery.\n\nPatients with cleft lip and palate undergo bone graft and orthognathic surgery. The study will compare the periodontal outcomes in patients who use these toothbrushes during the post-surgical period.', 'detailedDescription': 'Pilot Study, Randomized Control Clinical Trial, study groups 1) Craniofacial and/or unilateral and bilateral cleft palate patients undergoing orthognathic surgery . 2) Craniofacial and/or unilateral and bilateral cleft palate patients undergoing bone-graft surgery 3) Craniofacial and/or unilateral and bilateral cleft palate patients with no pending surgery. Three Investigational device include Dual Light Therapy Sonic Toothbrush (BristlTM Toothbrush), Sonic Toothbrush(BRistlTM) and manual toothbrush to target disease gingivitis in 189 patients. Categorical variables scored from Plaque Index and Gingival Index will be analyzed using Fisher exact test and McNemar test. Parametric methods will be used to analyze data from Bleeding on Probing and Periodontal Probing Depth. To determine differences between groups and within each test at all time points, Student t-test will be used.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '20 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient of record of the Craniofacial and Special Care Orthodontic Clinic at Children's Hospital Los Angeles\n* Between the ages of 6 and 20 years\n* Physical status of ASA I or II\n* Diagnosis of craniofacial and/or isolated, complete or incomplete, bilateral or unilateral cleft lip and palate\n\nExclusion Criteria:\n\n* physical inability to brush teeth\n* cognitive inability to comprehend and follow directions."}, 'identificationModule': {'nctId': 'NCT06122805', 'briefTitle': 'Effectiveness of Dual Light Electric Toothbrush vs. Manual Toothbrush in Orthodontic Patients Undergoing Oral Surgery', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital Los Angeles"}, 'officialTitle': 'Effectiveness of Dual Light Therapy Electric Toothbrush vs.Manual Toothbrush on Periodontal Health of Orthodontic Patients Undergoing Oral Surgery', 'orgStudyIdInfo': {'id': 'CHLA-23-00184'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Orthognathic Surgery Manual Toothbrush', 'description': "1. Patient of record of the Craniofacial and Special Care Orthodontic Clinic at Children's Hospital Los Angeles\n2. Between the ages of 6 and 20 years\n3. Physical status of ASA I or II\n4. Diagnosis of craniofacial and/or isolated, complete or incomplete, bilateral or unilateral cleft lip and palate\n5. Intervention: Manual toothbrush.", 'interventionNames': ['Device: Toothbrush']}, {'type': 'EXPERIMENTAL', 'label': 'Orthognathic Surgery Sonic toothbrush', 'description': "1. Patient of record of the Craniofacial and Special Care Orthodontic Clinic at Children's Hospital Los Angeles\n2. Between the ages of 6 and 20 years\n3. Physical status of ASA I or II\n4. Diagnosis of craniofacial and/or isolated, complete or incomplete, bilateral or unilateral cleft lip and palate\n5. Intervention:Sonic toothbrush without activation of the dual light feature.", 'interventionNames': ['Device: Toothbrush']}, {'type': 'EXPERIMENTAL', 'label': 'Orthognathic Surgery Sonic and dual light toothbrush', 'description': "1. Patient of record of the Craniofacial and Special Care Orthodontic Clinic at Children's Hospital Los Angeles\n2. Between the ages of 6 and 20 years\n3. Physical status of ASA I or II\n4. Diagnosis of craniofacial and/or isolated, complete or incomplete, bilateral or unilateral cleft lip and palate\n5. Intervention:Sonic toothbrush with activation of the dual light feature", 'interventionNames': ['Device: Toothbrush']}, {'type': 'EXPERIMENTAL', 'label': 'Bone Graft Manual Toothbrush', 'description': "1. Patient of record of the Craniofacial and Special Care Orthodontic Clinic at Children's Hospital Los Angeles\n2. Between the ages of 6 and 20 years\n3. Physical status of ASA I or II\n4. Diagnosis of craniofacial and/or isolated, complete or incomplete, bilateral or unilateral cleft lip and palate\n5. Intervention:Manual toothbrush.", 'interventionNames': ['Device: Toothbrush']}, {'type': 'EXPERIMENTAL', 'label': 'Bone Graft Sonic Toothbrush', 'description': "1. Patient of record of the Craniofacial and Special Care Orthodontic Clinic at Children's Hospital Los Angeles\n2. Between the ages of 6 and 20 years\n3. Physical status of ASA I or II\n4. Diagnosis of craniofacial and/or isolated, complete or incomplete, bilateral or unilateral cleft lip and palate\n5. Intervention:Sonic toothbrush without activation of the dual light feature.", 'interventionNames': ['Device: Toothbrush']}, {'type': 'EXPERIMENTAL', 'label': 'Bone Graft Sonic and Dual-light Toothbrush', 'description': "1. Patient of record of the Craniofacial and Special Care Orthodontic Clinic at Children's Hospital Los Angeles\n2. Between the ages of 6 and 20 years\n3. Physical status of ASA I or II\n4. Diagnosis of craniofacial and/or isolated, complete or incomplete, bilateral or unilateral cleft lip and palate\n5. Intervention:Sonic toothbrush with activation of the dual light feature", 'interventionNames': ['Device: Toothbrush']}, {'type': 'EXPERIMENTAL', 'label': 'No surgery, Manual Toothbrush', 'description': "1. Patient of record of the Craniofacial and Special Care Orthodontic Clinic at Children's Hospital Los Angeles\n2. Between the ages of 6 and 20 years\n3. Physical status of ASA I or II\n4. Diagnosis of craniofacial and/or isolated, complete or incomplete, bilateral or unilateral cleft lip and palate 5, Intervention:Manual toothbrush.", 'interventionNames': ['Device: Toothbrush']}, {'type': 'EXPERIMENTAL', 'label': 'No Surgery, Sonic Toothbrush', 'description': "1. Patient of record of the Craniofacial and Special Care Orthodontic Clinic at Children's Hospital Los Angeles\n2. Between the ages of 6 and 20 years\n3. Physical status of ASA I or II\n4. Diagnosis of craniofacial and/or isolated, complete or incomplete, bilateral or unilateral cleft lip and palate\n5. Intervention:Sonic toothbrush without activation of the dual light feature.", 'interventionNames': ['Device: Toothbrush']}, {'type': 'EXPERIMENTAL', 'label': 'No Surgery, Sonic and Dual-light Toothbrush', 'description': "1. Patient of record of the Craniofacial and Special Care Orthodontic Clinic at Children's Hospital Los Angeles\n2. Between the ages of 6 and 20 years\n3. Physical status of ASA I or II\n4. Diagnosis of craniofacial and/or isolated, complete or incomplete, bilateral or unilateral cleft lip and palate\n5. Intervention:Sonic toothbrush with activation of the dual light feature", 'interventionNames': ['Device: Toothbrush']}], 'interventions': [{'name': 'Toothbrush', 'type': 'DEVICE', 'description': 'We will test three toothbrushes in patients undergoing surgery and a control no surgery group. These toothbrushes are manual toothbrushes, sonic toothbrushes, and sonic and dual light toothbrushes.', 'armGroupLabels': ['Bone Graft Manual Toothbrush', 'Bone Graft Sonic Toothbrush', 'Bone Graft Sonic and Dual-light Toothbrush', 'No Surgery, Sonic Toothbrush', 'No Surgery, Sonic and Dual-light Toothbrush', 'No surgery, Manual Toothbrush', 'Orthognathic Surgery Manual Toothbrush', 'Orthognathic Surgery Sonic and dual light toothbrush', 'Orthognathic Surgery Sonic toothbrush']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Stephen Yen', 'role': 'CONTACT', 'email': 'syen@chla.usc.edu', 'phone': '323-361-2130'}, {'name': 'Jose Polido', 'role': 'CONTACT', 'email': 'jpolido@chla.usc.edu', 'phone': '3233612130'}], 'facility': "Chilldren's Hospital Los Angeles", 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'centralContacts': [{'name': 'Stephen Yen, DMD, PhD', 'role': 'CONTACT', 'email': 'syen@chla.usc.edu', 'phone': '3233612130'}, {'name': 'Jose Polido, DDS', 'role': 'CONTACT', 'email': 'jpolido@chla.usc.edu', 'phone': '3233612130'}], 'overallOfficials': [{'name': 'Stephen Yen, DMD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital Los Angeles and USC"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital Los Angeles", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Stephen Yen', 'investigatorAffiliation': "Children's Hospital Los Angeles"}}}}