Ignite Creation Date:
2025-12-25 @ 5:12 AM
Ignite Modification Date:
2025-12-26 @ 4:17 AM
Study NCT ID:
NCT02766127
Status:
COMPLETED
Last Update Posted:
2017-03-24
First Post:
2016-04-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of a Self-adhering Material in Dental Hypersensitivity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003807', 'term': 'Dentin Sensitivity'}, {'id': 'D014987', 'term': 'Xerostomia'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D012466', 'term': 'Salivary Gland Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C083395', 'term': 'universal dentin sealant'}, {'id': 'C503075', 'term': 'Clearfil Protect Bond'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-21', 'studyFirstSubmitDate': '2016-04-21', 'studyFirstSubmitQcDate': '2016-05-05', 'lastUpdatePostDateStruct': {'date': '2017-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of change of dentinal hypersensitivity after treatment', 'timeFrame': 'before the treatment (PRE-1), immediately after (POST-1), after 1 week (POST-2), 4 weeks (POST-3), and 12 weeks (POST-4).', 'description': "The pain experience was assessed by a Visual Analogue Scale (VAS) using the methodology. The VAS scale consisted of a horizontal line that was 100 mm long, on which 'no pain' was marked on the right-hand extremity and 'unbearable pain' on the other. The patients expressed the intensity of the pain experienced by placing a mark at any point along the continuum. The distance, expressed in millimetres, from the right edge of 'no pain' was used as the VAS score. Each patient was asked to rate the perception of discomfort after the application of air via a dental syringe at 45-60 psi, 1 cm at the cervical third of the tooth after removing supragingival plaque with a low- speed handpiece with pumice powder and without fluoride. The adjacent teeth were covered by cotton rolls. The stimulus was delivered until reaction or up to a maximum duration of 10 s by the same examiner with the same equipment yielding similar air pressure each time."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['radiotherapy'], 'conditions': ['Dentin Sensitivity', 'Xerostomia']}, 'referencesModule': {'references': [{'pmid': '25691810', 'type': 'BACKGROUND', 'citation': 'Pinna R, Campus G, Cumbo E, Mura I, Milia E. Xerostomia induced by radiotherapy: an overview of the physiopathology, clinical evidence, and management of the oral damage. Ther Clin Risk Manag. 2015 Feb 4;11:171-88. doi: 10.2147/TCRM.S70652. eCollection 2015.'}, {'pmid': '25609032', 'type': 'BACKGROUND', 'citation': 'Pinna R, Bortone A, Sotgiu G, Dore S, Usai P, Milia E. Clinical evaluation of the efficacy of one self-adhesive composite in dental hypersensitivity. Clin Oral Investig. 2015 Sep;19(7):1663-72. doi: 10.1007/s00784-014-1390-3. Epub 2015 Jan 23.'}, {'pmid': '22891890', 'type': 'BACKGROUND', 'citation': 'Milia E, Castelli G, Bortone A, Sotgiu G, Manunta A, Pinna R, Gallina G. Short-term response of three resin-based materials as desensitizing agents under oral environmental exposure. Acta Odontol Scand. 2013 May-Jul;71(3-4):599-609. doi: 10.3109/00016357.2012.700063. Epub 2012 Aug 15.'}]}, 'descriptionModule': {'briefSummary': 'Aim: To compare the desensitizing capacity of Vertise Flow™ (VF), a new self adhering material, in the treatment of dentine hypersensitivity (DH) in patients who are xerostomic due to radiotherapy for head and neck cancer.\n\nMethods: A total of 17 patients were selected for the study. The study was conducted as a split-mouth randomized clinical trial comparing: 1) VF 2) Universal Dentin Sealant (UDS), 3) Clearfil Protect Bond (CPB) and 4) Flor-Opal® Varnish (FOV). Basal and stimulated salivary flow was recorded for each patient according to the method described by Sreebny. The pain experience was generated by a cold stimulus directly to a sensitive tooth surface and assessed using the Visual Analogue Scale (VAS). The response was recorded before the application of the materials (PRE-1), immediately after (POST-1), at 1-week (POST-2), 4-weeks (POST-3) and 12-week controls (POST-4).', 'detailedDescription': "Participants The study was designed as a split-mouth randomized clinical trial. The protocol and informed consent forms were approved by the ethics committee at the University of Sassari (n° 1000/CE).\n\nTo participate in the study, all the subjects were carefully informed about the study's purpose, risks and benefits.\n\nThe study inclusion criteria were the following:\n\n* Generally good health despite the seriousness of their illness;\n* A clinical reduction of salivary flow;\n* The presence of two or three teeth which were hypersensitive to stimulation with a blast of air.\n\nIn addition, patients were considered suitable for the study if they had sensitive teeth showing abrasion, erosion or recession with the exposure of the cervical dentine.\n\nThe study exclusion criteria were:\n\n* teeth with subjective or objective evidence of carious lesions, pulpitis, restorations, premature contact, cracked enamel, active periapical infection or that had received periodontal surgery or root-planning up to 6 months prior to the investigation;\n* patients who had received professional desensitizing therapy during the previous 3 months;\n* patients who had used desensitizing toothpaste in the last 6 weeks. Patients were also excluded if they were under significant medication that could have interfered with pain perception (e.g., antidepressants, anti-inflammatory drugs, sedatives, and muscle relaxants).\n\nClinical Procedure\n\nSaliva collection\n\nAll salivary assessments were performed in the absence of acute sialadenitis. All assessments were performed by the same observer. The flow rate was determined in every person according to the method described by Sreebny. Saliva was collected in a standardised manner. Patients were instructed not to eat, drink, or smoke for 90 minutes before the sialometric assessment. All assessments were performed at a fixed time of the day, between 10 am and 1 pm, in order to minimise fluctuations related to a circadian rhythm of salivary secretion and composition. The whole saliva sample was collected in pre-weighed plastic tubes using electronic scales.\n\nUnstimulated salivary secretions were collected for 5 min with the patient seated in an upright position, with the head tilted forward . When possible the tongue, cheek and lip movements were limited during the procedure. At the end of the collection period the patient had to expectorate saliva into the test-tube. Stimulated whole saliva samples were collected by asking patients to chew a small block of paraffin wax or chewing gum. All the saliva secreted for 5 min was then collected in the test-tube. Measuring vessels were weighed after each collection using an electronic scales, and salivary flow rate was expressed in ml/min, which is nearly equivalent to g/min (31). A secretion rate \\< 0.1-0.2 ml/min for unstimulated flow and \\< 0.5-0.7 ml/min for stimulated flow was considered as an objective sign of hyposalivation.\n\nAssessment of hypersensitivity and application of desensitizing agents.\n\nA week before the experiment, patients received oral prophylaxis. Non-fluoride toothpaste (Biorepair, Coswell), a soft toothbrush (Oral-B Sensitive Advantage, Procter \\& Gamble) and oral hygiene instructions were also provided. The level of sensitivity experienced by each patient was considered as independent of the position of the hypersensitive tooth in the oral cavity. The pain experience was assessed by a Visual Analogue Scale (VAS) using the methodology described in our previous study. The pain experience was measured using a VAS graded from 1 to 10. The pain stimulus was given by one examiner with the same equipment yielding similar air pressure each time, while another one performed the treatments. The same operator carried out the sensitivity test evaluating the subject's response before the application of the materials (PRE-1), immediately after (POST-1), after 1 week (POST-2), 4 weeks (POST-3), and 12 weeks (POST-4) .\n\nThe following dental materials were used following the manufacturers' instructions: Verities Flow™ (VF) (Kerr Corporation, Orange, CA, USA), a self-adhering composite; Universal Dentin Sealant (UDS) (Ultradent Products Inc., South Jordan, UT, USA), a biocompatible, non-polymerizable, high molecular weight resin sealant in alcohol solvent; Clearfil Protect Bond (CPB), (Kuraray Noritake Dental, Osaka, Japan) a methacrylate-based resin, self-etching adhesive system, and Flor-Opal® Varnish (FOV), (Ultradent Products Inc., South Jordan, UT, USA), a fluoride-based varnish.\n\nIn view of the treatment with the desensitizing agents, teeth were randomly assigned into four groups (N = per group)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Generally good health despite the seriousness of their illness;\n* A clinical reduction of salivary flow;\n* The presence of two or three teeth which were hypersensitive to stimulation with a blast of air.\n\nIn addition, patients were considered suitable for the study if they had sensitive teeth showing abrasion, erosion or recession with the exposure of the cervical dentine.\n\nExclusion Criteria:\n\n* teeth with subjective or objective evidence of carious lesions, pulpitis, restorations, premature contact, cracked enamel, active periapical infection or that had received periodontal surgery or root-planning up to 6 months prior to the investigation;\n* patients who had received professional desensitizing therapy during the previous 3 months;\n* patients who had used desensitizing toothpaste in the last 6 weeks. Patients were also excluded if they were under significant medication that could have interfered with pain perception (e.g., antidepressants, anti-inflammatory drugs, sedatives, and muscle relaxants).'}, 'identificationModule': {'nctId': 'NCT02766127', 'briefTitle': 'Effect of a Self-adhering Material in Dental Hypersensitivity', 'organization': {'class': 'OTHER', 'fullName': 'Università degli Studi di Sassari'}, 'officialTitle': 'A Comparative Study of a Self-adhering Material in Dental Hypersensitivity in Xerostomic Patients Due to Radiotherapy', 'orgStudyIdInfo': {'id': '1000/CE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Xerostomic Patients', 'description': "Patients with evident clinical signs of xerostomia who experienced dentinal hypersensitivity after undergoing radiation therapy due to head and neck cancer.\n\nThe following dental materials will be used following the manufacturers' instructions: Veritise Flow; Universal Dentin Sealant; Clearfil Protect Bond, and Flor-Opal® Varnish. In view of the treatment with the desensitizing agents, teeth were randomly assigned into four groups.\n\nthe application of the materials will be made only once. The effectiveness will be evaluated: immediately after application and after 1, 4, 12 weeks.", 'interventionNames': ['Other: Veritise Flow', 'Other: Universal Dentin Sealant', 'Other: Clearfil Protect Bond', 'Other: Flor-Opal® Varnish']}], 'interventions': [{'name': 'Veritise Flow', 'type': 'OTHER', 'otherNames': ['Kerr Corporation, USA; Batch no. 3391829'], 'description': 'Self-adhering composite', 'armGroupLabels': ['Xerostomic Patients']}, {'name': 'Universal Dentin Sealant', 'type': 'OTHER', 'otherNames': ['Ultradent Products Inc., USA; Batch no. 052809'], 'description': 'non-polymerizable, high molecular weight resin sealant', 'armGroupLabels': ['Xerostomic Patients']}, {'name': 'Clearfil Protect Bond', 'type': 'OTHER', 'otherNames': ['Kuraray Noritake Dental, Japan; Batch no. 041212'], 'description': 'methacrylate-based resin, self-etching adhesive system', 'armGroupLabels': ['Xerostomic Patients']}, {'name': 'Flor-Opal® Varnish', 'type': 'OTHER', 'otherNames': ['Ultradent Products Inc., USA; Batch no. 122005'], 'description': 'fluoride-based varnish', 'armGroupLabels': ['Xerostomic Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07100', 'city': 'Sassari', 'state': 'Sassari', 'country': 'Italy', 'facility': 'Complex Operative Unit of Dentistry', 'geoPoint': {'lat': 40.72586, 'lon': 8.55552}}], 'overallOfficials': [{'name': 'Egle Milia, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Università degli Studi di Sassari'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Not a plan for data sharing has been established. But, for anyone researcher would like to have this information, simply they may request them to us directly.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Università degli Studi di Sassari', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof', 'investigatorFullName': 'Egle Milia', 'investigatorAffiliation': 'Università degli Studi di Sassari'}}}}