Tooth DecaysealantsNCT02896088
Effectiveness of Sealants on Molars
A study testing decayed tooth surfaces in people with Tooth Decay, run by University Hospital, Montpellier at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 3 to 7 years
- Conditions the study is for
- Tooth Decay
- What is being tested?
- decayed tooth surfaces
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2016to 30 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention of Dental Caries in Primary Molars on Sealants
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.
Read the 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
- Conditions
- Tooth Decay
- Being tested
- decayed tooth surfaces
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| test tooth groups | Other | test tooth groups Receives: Other: decayed tooth surfaces |
| control tooth groups | Other | control tooth groups Receives: Other: decayed tooth surfaces |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (2)
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.
Measured: 2 years
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.
Measured: 3years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2016 (estimated)
- Study start1 May 2016
- Primary completion1 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tooth DecayStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- test and control tooth groups. Each patient is therefore his own witness
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Estellle MOULIS, MCU-PH, Principal investigator, University Hospital, Montpellierolivier CHABADEL, MCU-PH, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02896088
- Sponsor's protocol ID
- 9500
- Acronym
- sealants
- Status last verified
- Nov 2020
- First submitted
- 6 Sep 2016
- Last updated
- 11 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 33377533
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Dental Caries in Primary Molars on Sealants
- ClinicalTrials.gov ID
- NCT02896088
- Acronym / sponsor ID
- sealants / 9500
- Conditions
- Tooth Decay
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 May 2016 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 12 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- test and control tooth groups. Each patient is therefore his own witness
| Arm | Type | Receives |
|---|---|---|
| test tooth groups | Other | Other: decayed tooth surfacestest tooth groups |
| control tooth groups | Other | Other: decayed tooth surfacescontrol tooth groups |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| decayed tooth surfacesThe 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. | Other | control tooth groups, test tooth groups |
Primary outcome
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.
2 secondary outcomes
decayed tooth surfaces
Time frame: 2 years
decayed tooth surfaces
Time frame: 3years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2022.
- Derived from this study: PubMed 33377533Chabadel 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Estellle MOULIS, MCU-PH principal investigator
University Hospital, Montpellier
olivier CHABADEL, MCU-PH principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing decayed tooth surfaces in people with Tooth Decay, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
decayed tooth surfaces (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02896088, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2022.