Clinical trial
Clinical Effectiveness of Early Treatments for Preventing Occlusal Caries Lesions in Erupting Permanent Molars
Name
H2023/012
Description
Sealants effectively arrest non-cavitated caries lesions on the fully erupted occlusal surface of permanent teeth. However, the clinical effectiveness of sealants is uncertain in preventing occlusal caries lesions in partially erupted permanent molars. This study aims to evaluate the progression of caries, the degree of retention, survival rate, and quality of the remnant after applying conventional total-etch resinous sealant and self-etch sealant in erupting molars.
Trial arms
Trial start
2023-07-31
Estimated PCD
2024-08-01
Trial end
2024-08-01
Status
Recruiting
Treatment
Fluoride varnish
Thirty-eight permanent molars will receive 5% sodium fluoride varnish application every three months
Arms:
Fluoride varnish group
Other names:
3M™ Clinpro™ White Varnish
Conventional etch and rinse sealant
Thirty-eight permanent molars will receive conventional etch and rinse sealant
Arms:
Conventional etch and rinse sealant group
Other names:
3M™ Clinpro™ Sealant
Self-etch sealant
Thirty-eight permanent molars will receive self-etch sealant
Arms:
Self-etch sealant group
Other names:
S-PRG filler-containing resin sealant, Beautisealant
Size
114
Primary endpoint
Development of new caries lesion
3 months
Development of new caries lesion
6 months
Development of new caries lesion
9 months
Development of new caries lesion
12 months
Eligibility criteria
Inclusion Criteria:
For children:
1. Children presenting with good general health and cooperative behavior.
2. Children having early caries lesions in a permanent molar (first or second).
3. Parents signed informed consent.
For permanent molars:
1. Early caries lesions on the occlusal surface corresponding to International Caries Detection and Assessment System (ICDAS) scores 1 and 2. \[Ismail AI, Sohn W, Tellez M, Amaya A, Sen A, Hasson H, Pitts NB. The International Caries Detection and Assessment System (ICDAS): an integrated system for measuring dental caries. Community Dent Oral Epidemiol. 2007 Jun;35(3):170-8\].
2. Erupting molars: eruption stages 2 (fully erupted occlusal surface with less than half of the crown exposed) and 3 (fully erupted occlusal surface with more than half of the crown exposed). \[Carvalho JC, Ekstrand KR, Thylstrup A. Dental plaque and caries on occlusal surfaces of first permanent molars in relation to stage of eruption. J Dent Res. 1989 May;68(5):773-9\].
Exclusion Criteria:
For children:
1. Any allergy reported by the parents.
2. Children unable to return for recall visits.
For permanent molars:
1. Teeth with occlusal surfaces completely covered by the gingival tissue.
2. Teeth with hypoplastic defects, restorations, or sealants.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a 3 arm clinical trial. All selected permanent molars will be randomly equally allocated into three groups according to material used.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Blinding of examiners is impossible to be done during intervention and follow up due to different natures of the materials. However, participants and outcome assessors could be blinded (double blinding).', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 114, 'type': 'ESTIMATED'}}
Updated at
2023-08-15
1 organization
3 products
2 indications
Organization
Hue University of Medicine and PharmacyProduct
Fluoride varnishIndication
initial cariesIndication
Dental CariesProduct
Self-etch sealant