Early Treatments for Preventing Occlusal Caries Lesions

NCT05969756 | Active Not Recruiting

• 1 other identifier: H2023/012
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 2

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.

Conditions

Caries; Initial; Occlusal Caries; Caries,Dental

Keywords

early caries lesions; sealants; erupting molars

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• Sealants retention

  3 months

• Sealants retention

  6 months

• Sealants retention

  9 months

• Sealants retention

  12 months

• Quality of sealants

  3 months

Study Arms (3)

Fluoride varnish group

EXPERIMENTAL

5% sodium fluoride varnish, 3M, USA

Drug: Fluoride varnish

Conventional etch and rinse sealant group

EXPERIMENTAL

Resin-based composite sealant, 3M, USA

Drug: Conventional etch and rinse sealant

Self-etch sealant group

ACTIVE COMPARATOR

Self-etch primed sealant, Shofu, Japan

Drug: Self-etch sealant

Interventions

Fluoride varnish DRUG

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

Also known as: 3M™ Clinpro™ White Varnish

Fluoride varnish group

Conventional etch and rinse sealant DRUG

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

Also known as: 3M™ Clinpro™ Sealant

Conventional etch and rinse sealant group

Self-etch sealant DRUG

Thirty-eight permanent molars will receive self-etch sealant

Also known as: S-PRG filler-containing resin sealant, Beautisealant

Self-etch sealant group

Eligibility Criteria

• Age: 5 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• For children:
• Children presenting with good general health and cooperative behavior.
• Children having early caries lesions in a permanent molar (first or second).
• Parents signed informed consent.
• For permanent molars:
• Early caries lesions on the occlusal surface corresponding to International Caries Detection and Assessment System (ICDAS) scores 1 and 2. \[Ismail AI, Sohn W, Tellez M, Amaya A, Sen A, Hasson H, Pitts NB. The International Caries Detection and Assessment System (ICDAS): an integrated system for measuring dental caries. Community Dent Oral Epidemiol. 2007 Jun;35(3):170-8\].
• 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). \[Carvalho JC, Ekstrand KR, Thylstrup A. Dental plaque and caries on occlusal surfaces of first permanent molars in relation to stage of eruption. J Dent Res. 1989 May;68(5):773-9\].

You may not qualify if:

• For children:
• Any allergy reported by the parents.
• Children unable to return for recall visits.
• For permanent molars:
• Teeth with occlusal surfaces completely covered by the gingival tissue.
• Teeth with hypoplastic defects, restorations, or sealants.

Sponsors & Collaborators

• Hue University of Medicine and Pharmacy: lead

Study Sites (2)

Hue University of Medicine and Pharmacy

Huế, Thừa Thiên Huế Province, 49120, Vietnam

Location

Phu Vang Hospital

Phú Vang, Thừa Thiên Huế Province, 49900, Vietnam

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Van Nhat Thang Le, DDS, PhD

  Hue University of Medicine and Pharmacy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDS, PhD, Principal Investigator

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

Study Record Dates

• First Submitted: July 23, 2023
• First Posted: August 1, 2023
• Study Start: July 31, 2023
• Primary Completion: October 10, 2024
• Study Completion: October 15, 2024
• Last Updated: September 20, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Plan to complete study in 1 year and will share the data after get publication

Locations

VN (2)