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

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ClinicalTrials.gov Identifier: NCT03315312
Recruitment Status : Recruiting
First Posted : October 20, 2017
Last Update Posted : October 20, 2017
Sponsor:
Collaborators:
Public Dental Service, Hedmark
Public Dental Service, Oppland
Public Dental Service, Østfold
Information provided by (Responsible Party):
Oral Health Centre of Expertise in Eastern Norway

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.


Condition or disease Intervention/treatment Phase
Dental Caries Pit and Fissure Dental Caries in Children Drug: Fluoride Varnishes Drug: Fissure Sealants Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Split-mouth design
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: FISSURE-Project. Improved Dental Decay Management in Dental Service for Children: Fissure Sealants or Fluoride Varnish?
Actual Study Start Date : February 1, 2017
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Dental caries incidence on occlusal surfaces of first molars [ Time Frame: 12 months after application ]
    Decayed, missing and filled surfaces (DMFS) increment

  2. Dental caries incidence on occlusal surfaces of first molars [ Time Frame: 24 months after application ]
    Decayed, missing and filled surfaces (DMFS) increment

  3. Dental caries incidence on occlusal surfaces of first molars [ Time Frame: 36 months after application ]
    Decayed, missing and filled surfaces (DMFS) increment



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Ages Eligible for Study:   6 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03315312


Contacts
Contact: Rasa Skudutyte-Rysstad, PhD +4723693926 rasas@ostfoldfk.no
Contact: Vibeke E Ansteinsson, PhD vibekean@ostfoldfk.no

Locations
Norway
Public Dental Service clinics at Østfold county Recruiting
Sarpsborg, Norway
Contact: Per David Søhoel, DDS       persoh@ostfoldfk.no   
Sponsors and Collaborators
Oral Health Centre of Expertise in Eastern Norway
Public Dental Service, Hedmark
Public Dental Service, Oppland
Public Dental Service, Østfold

Responsible Party: Oral Health Centre of Expertise in Eastern Norway
ClinicalTrials.gov Identifier: NCT03315312     History of Changes
Other Study ID Numbers: FISSURE
First Posted: October 20, 2017    Key Record Dates
Last Update Posted: October 20, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Fluorides
Fluorides, Topical
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs