Early Treatments for Preventing Occlusal Caries Lesions

Clinical Effectiveness of Early Treatments for Preventing Occlusal Caries Lesions in Erupting Permanent Molars

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.

Study Overview

• Status: Recruiting
• Conditions: Occlusal Caries; Caries,Dental; Caries; Initial
• Intervention / Treatment: Drug: Fluoride varnish; Drug: Conventional etch and rinse sealant; Drug: Self-etch sealant

• Study Type: Interventional
• Enrollment (Estimated): 114
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Van Nhat Thang Le, DDS, PhD; Phone Number: +84931199077; Email: lvnthang@hueuni.edu.vn

Study Locations

• Vietnam
  • Thua Thien Hue
    • Hue, Thua Thien Hue, Vietnam, 49120
      • Recruiting
      • Hue University of Medicine and Pharmacy
      • Contact: Thanh Thao Nguyen, MD, PhD; Email: stir@huemed-univ.edu.vn
    • Phu Vang, Thua Thien Hue, Vietnam, 49900
      • Recruiting
      • Phu Vang Hospital
      • Contact: Van Lich Tran, DDS; Email: tranvanlich85@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fluoride varnish group; 5% sodium fluoride varnish, 3M, USA	Drug: Fluoride varnish; Thirty-eight permanent molars will receive 5% sodium fluoride varnish application every three months; Other Names: 3M™ Clinpro™ White Varnish
Experimental: Conventional etch and rinse sealant group; Resin-based composite sealant, 3M, USA	Drug: Conventional etch and rinse sealant; Thirty-eight permanent molars will receive conventional etch and rinse sealant; Other Names: 3M™ Clinpro™ Sealant
Active Comparator: Self-etch sealant group; Self-etch primed sealant, Shofu, Japan	Drug: Self-etch sealant; Thirty-eight permanent molars will receive self-etch sealant; Other Names: S-PRG filler-containing resin sealant; Beautisealant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Development of new caries lesion	ICDAS was considered "0'' for fully sealed teeth. A score of ICDAS≥1 was considered as new caries lesion	3 months
Development of new caries lesion	ICDAS was considered "0'' for fully sealed teeth. A score of ICDAS≥1 was considered as new caries lesion	6 months
Development of new caries lesion	ICDAS was considered "0'' for fully sealed teeth. A score of ICDAS≥1 was considered as new caries lesion	9 months
Development of new caries lesion	ICDAS was considered "0'' for fully sealed teeth. A score of ICDAS≥1 was considered as new caries lesion	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sealants retention	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.	3 months
Sealants retention	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.	6 months
Sealants retention	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.	9 months
Sealants retention	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.	12 months
Quality of sealants	Quality of the remnant United States Public Health Service criteria (USPHS): anatomical shape, marginal adaptation, surface texture, and marginal discoloration.	3 months
Quality of sealants	Quality of the remnant United States Public Health Service criteria (USPHS): anatomical shape, marginal adaptation, surface texture, and marginal discoloration.	6 months
Quality of sealants	Quality of the remnant United States Public Health Service criteria (USPHS): anatomical shape, marginal adaptation, surface texture, and marginal discoloration.	9 months
Quality of sealants	Quality of the remnant United States Public Health Service criteria (USPHS): anatomical shape, marginal adaptation, surface texture, and marginal discoloration.	12 months

Collaborators and Investigators

• Sponsor: Hue University of Medicine and Pharmacy
• Investigators: Principal Investigator: Van Nhat Thang Le, DDS, PhD, Hue University of Medicine and Pharmacy

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2023
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: July 23, 2023
• First Submitted That Met QC Criteria: July 23, 2023
• First Posted (Actual): August 1, 2023

Study Record Updates

• Last Update Posted (Actual): August 15, 2023
• Last Update Submitted That Met QC Criteria: August 13, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: early caries lesions; sealants; erupting molars
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries; Physiological Effects of Drugs; Protective Agents; Cariostatic Agents; Fluorides; Fluorides, Topical
• Other Study ID Numbers: H2023/012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Will plan to share information when finishing study
• IPD Sharing Time Frame: Plan to complete study in 1 year and will share the data after get publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No