Occlusal Caries Management in First Permanent Molars in Child Dental Care

NCT03315312 | Unknown Phase 4

• 1 other identifier: FISSURE
• Study Type: interventional
• Target: 410
• Locations: 1 country
• Sites: 1

Brief Summary

Occlusal caries management in first permanent molars: a pragmatic randomized clinical trial in child dental care Aim of the present study is to evaluate the effectiveness of fissure sealants and fluoride varnish in a pragmatic randomized clinical trial and evaluate whether some specific patient groups benefit more from any particular treatment. The high risk children (having a previous caries experience at 5 years of age) from 2009, 2010 and 2011 birth cohorts (6-, 7- and 8-year-olds) from three counties (Østfold, Oppland and Hedmark) are selected. Children with at least two erupted first permanent molars in the same jaw randomly receive resin-based sealant or a fluoride varnish (Duraphat) during a routine dental examination. Children who already developed caries, had restorations or fissure sealants placed in first molars were excluded from the present study. Fluoride varnish and resin-based fissure sealants are randomly applied on contra-lateral teeth where each child serves as its own control. This study uses a natural clinical setting, where clinicians use methods and procedures that are routinely applied in public dental clinics. The study is approved by the Regional Committee for Medical Research Ethics South East (2016/2002/REK sør-øst C). Sample size calculations: Based on the assumption that 80% of the treated teeth do not get caries and that 10% difference in caries development constitutes a clinically meaningful difference, it is required to recruit 180 participants in the study for the split-mouth design. Considering a potential maximum of annual 20% drop-out rate and a 3-years follow-up, the study will need to recruit 400 participants in order to have at least 206 children at the 3 years of follow-up. Treatments are provided by either dentists or dental hygienists during routine dental examinations. Caregivers of eligible children are informed about the study, the participation is voluntary and an informed written parental consent is obtained in accordance with the directions of the Regional Committee for Medical Research Ethics. In this study, a clinician selects a random treatment for the first tooth by choosing one of the two cards, while a collateral tooth receives an alternative treatment. Subsequently, treatments provided and materials used are recorded on a treatment registration form. During this study, clinicians follow their conventional clinical procedures for applying sealants or fluoride varnish. Information on patient's caries experience and quality of oral hygiene are recorded on treatment registration form. Fluoride varnish is applied three times, at baseline, 6 months and 12 months. Caries on occlusal surfaces of first molars detected at later 24 and 36 months follow-ups will be recorded in the follow-up registration form. The main study outcome is caries occurrence on occlusal tooth surfaces.

Conditions

Dental Caries Pit and Fissure; Dental Caries in Children

Outcome Measures

Primary Outcomes (3)

• Dental caries incidence on occlusal surfaces of first molars

  Decayed, missing and filled surfaces (DMFS) increment

  12 months after application

• Dental caries incidence on occlusal surfaces of first molars

  Decayed, missing and filled surfaces (DMFS) increment

  24 months after application

• Dental caries incidence on occlusal surfaces of first molars

  Decayed, missing and filled surfaces (DMFS) increment

  36 months after application

Study Arms (2)

Fissure sealant

ACTIVE COMPARATOR

Drug: Fissure Sealants

Fluoride varnish

EXPERIMENTAL

Drug: Fluoride Varnishes

Interventions

Fluoride Varnishes DRUG

Fluoride varnish is randomly applied on randomly selected first permanent molar. This study uses a natural clinical setting, where clinicians use methods and procedures that are routinely applied in public dental clinics.

Fluoride varnish

Fissure Sealants DRUG

Resin-based fissure sealant is applied on contra-lateral first permanent molar and each child serves as its own control. This study uses a natural clinical setting, where clinicians use methods and procedures that are routinely applied in public dental clinics.

Fissure sealant

Eligibility Criteria

• Age: 6 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• The high risk children (having a previous caries experience at 5 years of age) with at least two erupted first permanent molars

You may not qualify if:

• Children who already developed caries, had restorations or fissure sealants placed in first molars are excluded from the present study.

Sponsors & Collaborators

• Oral Health Centre of Expertise in Eastern Norway: lead
• Public Dental Service, Hedmark: collaborator
• Public Dental Service, Oppland: collaborator
• Public Dental Service, Østfold: collaborator

Study Sites (1)

Public Dental Service clinics at Østfold county

Sarpsborg, Norway

Location

MeSH Terms

Interventions

Fluorides, Topical; Pit and Fissure Sealants

Intervention Hierarchy (Ancestors)

Fluorides; Hydrofluoric Acid; Fluorine Compounds; Inorganic Chemicals; Cariostatic Agents; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Dental Materials

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Split-mouth design

Study Record Dates

• First Submitted: October 11, 2017
• First Posted: October 20, 2017
• Study Start: February 1, 2017
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: October 31, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)