Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2026-02-23 @ 4:55 AM
Study NCT ID:
NCT06772051
Status:
RECRUITING
Last Update Posted:
2025-01-13
First Post:
2025-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Evaluation of Short Dentin Etching
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003807', 'term': 'Dentin Sensitivity'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Double (Participant, Investigator)'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': "Each patient will receive three restorations in posterior teeth randomly on three different quadrants, each tooth will be restored with one of the three tested adhesive strategies. All materials will be used according to manufacturers' instructions"}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-08', 'studyFirstSubmitDate': '2025-01-04', 'studyFirstSubmitQcDate': '2025-01-08', 'lastUpdatePostDateStruct': {'date': '2025-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-24', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative hypersensitivity/pulp status', 'timeFrame': 'Two years after restoration', 'description': 'The postoperative hypersensitivity/pulp status will be assessed based on the updated FDI criteria. This parameter is evaluated by scoring the pain experienced during chewing and/or with cold or warm food items, as reported by the patient. The criteria consist of five scores: scores 1-3 indicate success, score 4 indicates the need for restoration repair, and score 5 indicates the need for restoration replacement.'}, {'measure': 'Marginal adaptation', 'timeFrame': 'Two years after restoration', 'description': 'The marginal adaptation will be evaluated through visual examination using a 250 µm probe and brief air drying. This assessment will be conducted according to the updated FDI criteria. The criteria consist of five scores: scores 1-3 indicate success, score 4 indicates the need for restoration repair, and score 5 indicates the need for restoration replacement.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypersensitivity Dentin', 'Dental Restoration Failure of Marginal Integrity']}, 'descriptionModule': {'briefSummary': 'To evaluate and compare the two-year clinical performance of Class I resin composite restorations utilizing a universal adhesive used in different etch-and-rinse strategies (15-second and 5-second etching) and self-etch strategies for bonding.', 'detailedDescription': "The experimental design description adhered to the guidelines provided by the Consolidated Standards of Reporting Trials (CONSORT) statement. The present study is planned as a double-blinded randomized clinical trial, ensuring that both the patients and the examiner are unaware of the treatment allocation. The trial will follow a split mouth design. A total of thirty adult patients, who are seeking dental treatment, will be enrolled in the study. The participants will be recruited from the Operative Department clinic at the Faculty of Dentistry, University of Mansoura. The study will focus on ninety Class I restorations. No active advertisement will be used for participant recruitment, and instead, a convenience sample will be formed. Prior to participating in the study, each patient will be required to provide informed consent by signing a consent form. The study is scheduled to be conducted from December 2024 to December 2026. The form and protocol of the study will be approved by Mansoura University's ethics committee before initiation. To determine the appropriate sample size, previous studies examining the clinical success rate of posterior Class I restorations restored using different adhesive strategies were considered. Based on various parameters, including a significance level of 5%, a test power of 80%, and an equivalence limit of 15%, the sample size was calculated. Considering a potential dropout rate of 20%, a sample size of 30 subjects (Three restorations per patient) was determined to be suitable."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with three primary occlusal caries of upper or lower posterior teeth.\n* Patients must have a good oral hygiene;\n* Patients with tooth gives a positive response to testing with an electric pulp tester\n* Patients with normal and full occlusion,\n* Patients with opposing teeth should be natural with no restorations.\n\nExclusion Criteria:\n\n* High caries risk patients with extremely poor oral hygiene\n\n * Patients involved in orthodontic treatment or periodontal surgery,\n * Patients with periodontally involved teeth (chronic'}, 'identificationModule': {'nctId': 'NCT06772051', 'briefTitle': 'Clinical Evaluation of Short Dentin Etching', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Short Dentin Etching With a Universal Adhesive: Two-Year Double-Blind Trial Comparing Etching Strategies and Durations', 'orgStudyIdInfo': {'id': 'A04012024 CD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Dentin etching and rinse (15 seconds etching)', 'description': 'The dentin in the pulpal floor in this group will receive phosphoric acid etching for 15 seconds followed by rinsing and drying before universal adhesive application', 'interventionNames': ['Procedure: Resin composite restoration bonded using universal adhesive in etch and rinse mode (15 seconds etching)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dentin etching and rinse (5 seconds etching)', 'description': 'The dentin in the pulpal floor in this group will receive phosphoric acid etching for 5 seconds followed by rinsing and drying before universal adhesive application', 'interventionNames': ['Procedure: Resin composite restoration bonded using universal adhesive in etch and rinse mode (5 seconds etching)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Dentin self-etch', 'description': 'The dentin in the pulpal floor in this group will receive universal adhesive application in self-etch mode without prior phosphoric acid etching', 'interventionNames': ['Procedure: Resin composite restoration bonded using universal adhesive in self-etch mode']}], 'interventions': [{'name': 'Resin composite restoration bonded using universal adhesive in etch and rinse mode (15 seconds etching)', 'type': 'PROCEDURE', 'description': 'Resin composite restoration bonded using universal adhesive in etch and rinse mode (15 seconds etching)', 'armGroupLabels': ['Dentin etching and rinse (15 seconds etching)']}, {'name': 'Resin composite restoration bonded using universal adhesive in etch and rinse mode (5 seconds etching)', 'type': 'PROCEDURE', 'description': 'Resin composite restoration bonded using universal adhesive in etch and rinse mode (5 seconds etching)', 'armGroupLabels': ['Dentin etching and rinse (5 seconds etching)']}, {'name': 'Resin composite restoration bonded using universal adhesive in self-etch mode', 'type': 'PROCEDURE', 'description': 'Resin composite restoration bonded using universal adhesive in self-etch mode', 'armGroupLabels': ['Dentin self-etch']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35516', 'city': 'Al Mansurah', 'state': 'Dakahliya', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Hoda S Ismail, Lecturer', 'role': 'CONTACT'}], 'facility': 'Faculty of Dentistry, Mansoura University, Egypt', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'centralContacts': [{'name': 'Hoda S Ismail, Lecturer', 'role': 'CONTACT', 'email': 'hoda_saleh@mans.edu.eg', 'phone': '01005395069'}], 'overallOfficials': [{'name': 'Hoda S Ismail, Lecturer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Dentistry, Mansoura University, Egypt'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}