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Effectiveness of Sealants on Molars (sealants)

Primary Purpose

Tooth Decay

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
decayed tooth surfaces
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Tooth Decay

Eligibility Criteria

3 Years - 7 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Children involved in other research in the same field
  • Child is exclusion period determined by previous research
  • Children participating in research in the last three months its inclusion
  • Parents do not understand French.
  • Children deprived of liberty.
  • Child participation Refusal
  • Refusal to participate in either of the parents or legal representative

Sites / Locations

  • MOULIS

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

test tooth groups

control tooth groups

Arm Description

test tooth groups

control tooth groups

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
September 6, 2016
Last Updated
August 10, 2022
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT02896088
Brief Title
Effectiveness of Sealants on Molars
Acronym
sealants
Official Title
Prevention of Dental Caries in Primary Molars on Sealants
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
May 1, 2016 (Actual)
Primary Completion Date
June 1, 2018 (Actual)
Study Completion Date
June 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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. Main objective: To evaluate the effect of AS on caries incidence in the deciduous dentition obtained over a period of three years, taking into account the risk of caries established initially. Secondary objectives: To assess the prevalence and caries attack sites at the end of each year Estimate the retention rate (partial or complete) of the AS during the study Determine the cost savings of treatment during the trial period

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Decay

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
test and control tooth groups. Each patient is therefore his own witness
Masking
Participant
Masking Description
test and control tooth groups. Each patient is therefore his own witness
Allocation
Non-Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
test tooth groups
Arm Type
Other
Arm Description
test tooth groups
Arm Title
control tooth groups
Arm Type
Other
Arm Description
control tooth groups
Intervention Type
Other
Intervention Name(s)
decayed tooth surfaces
Intervention Description
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.
Primary Outcome Measure Information:
Title
decayed tooth surfaces
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
decayed tooth surfaces
Description
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.
Time Frame
2 years
Title
decayed tooth surfaces
Description
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.
Time Frame
3years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Children involved in other research in the same field Child is exclusion period determined by previous research Children participating in research in the last three months its inclusion Parents do not understand French. Children deprived of liberty. Child participation Refusal Refusal to participate in either of the parents or legal representative
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Estellle MOULIS, MCU-PH
Organizational Affiliation
University Hospital, Montpellier
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
olivier CHABADEL, MCU-PH
Organizational Affiliation
University Hospital, Montpellier
Official's Role
Principal Investigator
Facility Information:
Facility Name
MOULIS
City
Montpellier
ZIP/Postal Code
34295
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33377533
Citation
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.
Results Reference
derived

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Effectiveness of Sealants on Molars

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