Clinical trial NCT02896088: Effectiveness of Sealants on Molars
Official title: Prevention of Dental Caries in Primary Molars on Sealants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Decay
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2016-09-12
Enrollment: 90
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: test and control tooth groups. Each patient is therefore his own witness
Primary purpose: PREVENTION

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:

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

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

Primary outcomes:
measure: decayed tooth surfaces
timeFrame: 1 year
Secondary outcomes:
measure: decayed tooth surfaces
timeFrame: 2 years
measure: decayed tooth surfaces
timeFrame: 3years
Other outcomes:
Locations:
city: Montpellier
country: France
facility: MOULIS
Study officials:
affiliation: University Hospital, Montpellier
name: Estellle MOULIS, MCU-PH
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Montpellier
name: olivier CHABADEL, MCU-PH
role: PRINCIPAL_INVESTIGATOR
References:
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.