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Effectiveness of Sealants on Molars (sealants)

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ClinicalTrials.gov Identifier: NCT02896088
Recruitment Status : Recruiting
First Posted : September 12, 2016
Last Update Posted : September 12, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

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.

Condition or disease Intervention/treatment
Tooth Decay Other: decayed tooth surfaces

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:

  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

Study Type : Observational
Estimated Enrollment : 200 participants
Time Perspective: Prospective
Official Title: Prevention of Dental Caries in Primary Molars on Sealants
Study Start Date : September 2015
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay


Intervention Details:
  • 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.


Primary Outcome Measures :
  1. decayed tooth surfaces [ Time Frame: 1 year ]
    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 :
  1. decayed tooth surfaces [ Time Frame: 2 years ]
    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. decayed tooth surfaces [ Time Frame: 3years ]
    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.



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Ages Eligible for Study:   3 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
healthy molars with occlusal surface or non cavitary initial injury.
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

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): NCT02896088


Contacts
Contact: Estellle MOULIS, MCU-PH 4 67 33 67 14 ext 33 moulis.e@hotmail.fr
Contact: olivier CHABADEL, MCU-PH 4 67 33 67 14 ext 33 olivier.chabadel@wanadoo.fr

Locations
France
MOULIS Recruiting
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
Principal Investigator: Estellle MOULIS, MCU-PH University Hospital, Montpellier
Principal Investigator: olivier CHABADEL, MCU-PH University Hospital, Montpellier

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02896088     History of Changes
Other Study ID Numbers: 9500
First Posted: September 12, 2016    Key Record Dates
Last Update Posted: September 12, 2016
Last Verified: November 2014
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided