Effectiveness of Sealants on Molars

Tooth Decay Clinical Trial

— sealants  

Official title:

Prevention of Dental Caries in Primary Molars on Sealants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02896088
• Other study ID #: 9500
• Status: Completed
• Phase: N/A
• Start date: May 1, 2016
• Est. completion date: June 30, 2018

Study information

• Verified date: November 2020
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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:

1. To assess the prevalence and caries attack sites at the end of each year

2. Estimate the retention rate (partial or complete) of the AS during the study

3. Determine the cost savings of treatment during the trial period

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: June 30, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 7 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Caries
• Tooth Decay

Intervention

Other:
• 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.

Locations

Country	Name	City	State
France	MOULIS	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	2 years
Secondary	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.	3years