Early Treatments for Preventing Occlusal Caries Lesions

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-31

Study Completion Date

2024-10-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Prevention of Dental Caries Lesions With Fluoride Varnish in Erupting First Permanent Molars

NCT02592278

Dental Caries

COMPLETED PHASE4

Progression of Active Microcavitated Carious Lesions on Primary Molar Occlusal Surfaces

NCT04127357

Dental Caries in Children Pit and Fissure Sealant Toothbrushing

COMPLETED NA

Effectiveness of Sealants on Molars

NCT02896088

Tooth Decay

COMPLETED NA

Microbiological Evaluation and Clinical 24-month Follow-up of Adhesive Systems on Carious Dentin

NCT05676671

Dental Caries

COMPLETED NA

Effectiveness of Fissure Sealant and Topical Fluoride Application in Preventing Dental Caries

NCT01446107

Dental Caries

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Caries; Initial Occlusal Caries Caries,Dental

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a 3 arm clinical trial. All selected permanent molars will be randomly equally allocated into three groups according to material used.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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).

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Fluoride varnish group

5% sodium fluoride varnish, 3M, USA

Group Type EXPERIMENTAL

Fluoride varnish

Intervention Type DRUG

Thirty-eight permanent molars will receive 5% sodium fluoride varnish application every three months

Conventional etch and rinse sealant group

Resin-based composite sealant, 3M, USA

Group Type EXPERIMENTAL

Conventional etch and rinse sealant

Intervention Type DRUG

Thirty-eight permanent molars will receive conventional etch and rinse sealant

Self-etch sealant group

Self-etch primed sealant, Shofu, Japan

Group Type ACTIVE_COMPARATOR

Self-etch sealant

Intervention Type DRUG

Thirty-eight permanent molars will receive self-etch sealant

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fluoride varnish

Thirty-eight permanent molars will receive 5% sodium fluoride varnish application every three months

Intervention Type DRUG

Conventional etch and rinse sealant

Thirty-eight permanent molars will receive conventional etch and rinse sealant

Intervention Type DRUG

Self-etch sealant

Thirty-eight permanent molars will receive self-etch sealant

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

3M™ Clinpro™ White Varnish 3M™ Clinpro™ Sealant S-PRG filler-containing resin sealant Beautisealant

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

5 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes