Occlusal Caries Management in First Permanent Molars in Child Dental Care (FISSURE)

FISSURE-Project. Improved Dental Decay Management in Dental Service for Children: Fissure Sealants or Fluoride Varnish?

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Dental Caries in Children; Dental Caries Pit and Fissure
• Intervention / Treatment: Drug: Fissure Sealants; Drug: Fluoride Varnishes

• Study Type: Interventional
• Enrollment (Actual): 410
• Phase: Phase 4

Contacts and Locations

Study Locations

• Norway
  • Sarpsborg, Norway
    • Public Dental Service clinics at Østfold county

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 5 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fissure sealant	Drug: Fissure Sealants; 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.
Experimental: Fluoride varnish	Drug: Fluoride Varnishes; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Oral Health Centre of Expertise in Eastern Norway
• Collaborators: Public Dental Service, Hedmark; Public Dental Service, Oppland; Public Dental Service, Østfold

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Actual): December 31, 2022
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: October 11, 2017
• First Submitted That Met QC Criteria: October 16, 2017
• First Posted (Actual): October 20, 2017

Study Record Updates

• Last Update Posted (Actual): October 31, 2023
• Last Update Submitted That Met QC Criteria: October 30, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• 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: FISSURE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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