NCT02896088

Brief Summary

Currently, the real scope of sealants (AS) is poorly documented in temporary dentition and its effectiveness has not been demonstrated. Yet it seems reasonable that the AS in temporary dentition could slow the specific development of carious lesions in early childhood. In addition, this non-invasive approach could delay the conventional food and thus save financial costs for more complex treatments. Finally, the installation of AS could afford, as demonstrated in adult teeth, lowering the cariogenic bacteria prevalence engaged in the caries process.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 12, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

August 11, 2022

Status Verified

November 1, 2020

Enrollment Period

2.1 years

First QC Date

September 6, 2016

Last Update Submit

August 10, 2022

Conditions

Tooth Decay

Outcome Measures

Primary Outcomes (1)

  • decayed tooth surfaces

    The main variable is the number of new decayed tooth surfaces between the end and the beginning of the research. The caries experience will also be evaluated and expressed by the index 'dmfs' (accumulation of decayed tooth surfaces over those missing or filled due to caries). The secondary variable will be the expression of the retention of AS. The comparison of caries incidence between the two groups of teeth (with and without AS) will take into account the membership of the teeth to the same subject by means of the statistical test Chi-McNemar two. Regression models logistics and Poisson regression will be used to test the effect of independent variables on the appearance of new cavities. The Stata statistical software will be used.

    1 year

Secondary Outcomes (2)

  • decayed tooth surfaces

    2 years

  • decayed tooth surfaces

    3years

Study Arms (2)

test tooth groups

OTHER

test tooth groups

Other: decayed tooth surfaces

control tooth groups

OTHER

control tooth groups

Other: decayed tooth surfaces

Interventions

decayed tooth surfacesOTHER

The main variable is the number of new decayed tooth surfaces between the end and the beginning of the research. The caries experience will also be evaluated and expressed by the index 'dmfs' (accumulation of decayed tooth surfaces over those missing or filled due to caries). The secondary variable will be the expression of the retention of AS. The comparison of caries incidence between the two groups of teeth (with and without AS) will take into account the membership of the teeth to the same subject by means of the statistical test Chi-McNemar two. Regression models logistics and Poisson regression will be used to test the effect of independent variables on the appearance of new cavities. The Stata statistical software will be used.

control tooth groupstest tooth groups

Eligibility Criteria

Age3 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children who have at least two pairs (test / control) of healthy molars with occlusal surface or non cavitary initial injury.
  • Children available for a follow-up 3 years
  • Children being affiliated or beneficiary in a health insurance plan

You may not qualify if:

  • Children involved in other research in the same field
  • Parents do not understand French.
  • Children deprived of liberty.
  • Child participation Refusal
  • Refusal to participate in either of the parents or legal representative

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MOULIS

Montpellier, 34295, France

Location

Related Publications (1)

  • Chabadel O, Veronneau J, Montal S, Tramini P, Moulis E. Effectiveness of pit and fissure sealants on primary molars: A 2-yr split-mouth randomized clinical trial. Eur J Oral Sci. 2021 Feb;129(1):e12758. doi: 10.1111/eos.12758. Epub 2020 Dec 30.

    PMID: 33377533DERIVED

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Estellle MOULIS, MCU-PH

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

  • olivier CHABADEL, MCU-PH

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
test and control tooth groups. Each patient is therefore his own witness
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: test and control tooth groups. Each patient is therefore his own witness
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2016

First Posted

September 12, 2016

Study Start

May 1, 2016

Primary Completion

June 1, 2018

Study Completion

June 30, 2018

Last Updated

August 11, 2022

Record last verified: 2020-11

Locations

FR(1)