Early Treatments for Preventing Occlusal Caries Lesions

Hue University of Medicine and Pharmacy

Status: Active, not recruiting

Conditions: Caries; Initial; Caries,Dental; Occlusal Caries

Treatments: Drug: Fluoride varnish; Drug: Self-etch sealant; Drug: Conventional etch and rinse sealant

Study type: Interventional

Funder types: Other

Identifiers

NCT05969756

H2023/012

Details and patient eligibility

About

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.

Enrollment: 114 estimated patients

Sex: All

Ages: 5 to 14 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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114 participants in 3 patient groups

Fluoride varnish group

Experimental group

Description:

5% sodium fluoride varnish, 3M, USA

Treatment:

Drug: Fluoride varnish

Conventional etch and rinse sealant group

Experimental group

Description:

Resin-based composite sealant, 3M, USA

Treatment:

Drug: Conventional etch and rinse sealant

Self-etch sealant group

Active Comparator group

Description:

Self-etch primed sealant, Shofu, Japan

Treatment:

Drug: Self-etch sealant