Early Treatments for Preventing Occlusal Caries Lesions

Not Applicable

Recruiting

• Conditions: Caries,Dental; Occlusal Caries; Caries; Initial
• Interventions: Drug: Self-etch sealant; Drug: Fluoride varnish; Drug: Conventional etch and rinse sealant

• Registration Number: NCT05969756
• Lead Sponsor: Hue University of Medicine and Pharmacy

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-23
• Study First Submitted QC: 2023-07-23
• Study Start: 2023-07-31
• Status Verified: 2023-08
• Study First Posted: 2023-08-01
• Last Update Submitted: 2023-08-13
• Last Update Posted: 2023-08-15
• Primary Completion: 2024-08
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 114

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Self-etch sealant group	Self-etch sealant	Self-etch primed sealant, Shofu, Japan
Fluoride varnish group	Fluoride varnish	5% sodium fluoride varnish, 3M, USA
Conventional etch and rinse sealant group	Conventional etch and rinse sealant	Resin-based composite sealant, 3M, USA

Primary Outcome Measures

Name	Time	Method
Development of new caries lesion	12 months	ICDAS was considered "0'' for fully sealed teeth. A score of ICDAS≥1 was considered as new caries lesion

Secondary Outcome Measures

Name	Time	Method
Sealants retention	12 months	Sealant retention was assessed as follows: total retention of sealant on the occlusal surface or the partial or complete absence of the sealant on the occlusal surface.
Quality of sealants	12 months	Quality of the remnant United States Public Health Service criteria (USPHS): anatomical shape, marginal adaptation, surface texture, and marginal discoloration.

Trial Locations

Locations (2)

Hue University of Medicine and Pharmacy; 🇻🇳 Hue, Thua Thien Hue, Vietnam

Phu Vang Hospital; 🇻🇳 Phu Vang, Thua Thien Hue, Vietnam