Enamel LesionsNCT02594020
Comparison of Different Methods of Enamel Preparation Before Pit and Fissure Sealants
A study testing air abrasion, sono abrasion and dental bur in people with Enamel Lesions and Dental Caries, run by Centre Hospitalier Universitaire de Nice at 2 sites in France.
Trial summary
This study concerns the prevention of dental caries by sealing pits and fissures of permanent molars with a photopolymerizable resin. It must compare these three techniques Microdentisty (air abrasion, abrasion and sound using small cutters) usually used to prepare micro cavities in the enamel and / or the outer third… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Enamel Lesions, Dental Caries
- What is being tested?
- air abrasion, sono abrasion and dental bur
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 2 sitesFrance
- Study dates
- Jun 2008to Dec 2015
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Affiliated with the Social Security
- Attendance at inspections
- Subject to high individual risk of caries
- Subjects with at least two pairs of molars and contralateral counterparts with the initial lesions of enamel (pits and fissures colored) or suspected of dentine caries (not highlighted by two clinical and radiographic examination usual)
Who cannot join
- Molar inaccessible, closed, sealed, or decayed (reaching the dentine
Trial locations and contacts
2 sites in 1 country.
About this study
This study concerns the prevention of dental caries by sealing pits and fissures of permanent molars with a photopolymerizable resin. It must compare these three techniques Microdentisty (air abrasion, abrasion and sound using small cutters) usually used to prepare micro cavities in the enamel and / or the outer third of the dentin. These three commonly used techniques have never been compared by retaining as endpoint retention of sealant. These techniques are painless and do not require local anesthesia.
- Conditions
- Enamel Lesions, Dental Caries
- Being tested
- air abrasion, sono abrasion, dental bur
- Keywords
- suspected caries, initial enamel lesions
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
air abrasionProcedure or surgery
already used intervention to prepare micro cavities of the dental to be treated by a photopolymerizable resin
sono abrasionProcedure or surgery
already used intervention to prepare micro cavities of the dental to be treated by a photopolymerizable resin
dental burProcedure or surgery
already used intervention to prepare micro cavities of the dental to be treated by a photopolymerizable resin
| Study group | Role | What they receive |
|---|---|---|
| dental bur versus air abrasion | Other | 1 tooth prepared with air abrasion versus one prepared tooth with dental bur Receives: Procedure: air abrasion; Procedure: dental bur |
| sono abrasion versus dental bur | Other | 1 tooth prepared with sono abrasion ans 1 tooth prepared with dental bur Receives: Procedure: sono abrasion; Procedure: dental bur |
| air abrasion versus sono abrasion | Other | 1 tooth prepared with air abrasion versus 1 tooth prepared with sono abrasion Receives: Procedure: air abrasion; Procedure: sono abrasion |
What is being measured
The primary outcome is the main question the study is designed to answer.
observation of quality of treatment
Compare enamel preparation techniques of air abrasion and sound abrasion technique enameloplasty (pits and fissures extended to the dental bur) the more conventionally used to identify the most effective as using endpoint retention of material sealing of pits and fissures.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2015 (estimated)
- Study startJun 2008
- Primary completionDec 2013
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enamel LesionsStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02594020
- Sponsor's protocol ID
- 08-PP-09
- Status last verified
- Sep 2015
- First submitted
- 4 Jun 2013
- Last updated
- 25 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Different Methods of Enamel Preparation Before Pit and Fissure Sealants
- ClinicalTrials.gov ID
- NCT02594020
- Acronym / sponsor ID
- 08-PP-09
- Conditions
- Enamel Lesions, Dental Caries
- Keywords
- suspected caries, initial enamel lesions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 2 Nov 2015 (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.
This study concerns the prevention of dental caries by sealing pits and fissures of permanent molars with a photopolymerizable resin. It must compare these three techniques Microdentisty (air abrasion, abrasion and sound using small cutters) usually used to prepare micro cavities in the enamel and / or the outer third of the dentin. These three commonly used techniques have never been compared by retaining as endpoint retention of sealant. These techniques are painless and do not require local anesthesia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| dental bur versus air abrasion | Other | Procedure: air abrasion, Procedure: dental bur1 tooth prepared with air abrasion versus one prepared tooth with dental bur |
| sono abrasion versus dental bur | Other | Procedure: sono abrasion, Procedure: dental bur1 tooth prepared with sono abrasion ans 1 tooth prepared with dental bur |
| air abrasion versus sono abrasion | Other | Procedure: air abrasion, Procedure: sono abrasion1 tooth prepared with air abrasion versus 1 tooth prepared with sono abrasion |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Affiliated with the Social Security
- Attendance at inspections
- Subject to high individual risk of caries
- Subjects with at least two pairs of molars and contralateral counterparts with the initial lesions of enamel (pits and fissures colored) or suspected of dentine caries (not highlighted by two clinical and radiographic examination usual)
Key exclusion criteria (1 listed)
- Molar inaccessible, closed, sealed, or decayed (reaching the dentine
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 |
|---|---|---|
| air abrasionalready used intervention to prepare micro cavities of the dental to be treated by a photopolymerizable resin | Procedure or surgery | air abrasion versus sono abrasion, dental bur versus air abrasion |
| sono abrasionalready used intervention to prepare micro cavities of the dental to be treated by a photopolymerizable resin | Procedure or surgery | air abrasion versus sono abrasion, sono abrasion versus dental bur |
| dental buralready used intervention to prepare micro cavities of the dental to be treated by a photopolymerizable resin | Procedure or surgery | dental bur versus air abrasion, sono abrasion versus dental bur |
Primary outcome
observation of quality of treatment
Time frame: 2 years
Compare enamel preparation techniques of air abrasion and sound abrasion technique enameloplasty (pits and fissures extended to the dental bur) the more conventionally used to identify the most effective as using endpoint retention of material sealing of pits and fissures.
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 25 Apr 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing air abrasion, sono abrasion and dental bur in people with Enamel Lesions and Dental Caries, run by Centre Hospitalier Universitaire de Nice at 2 sites 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 4 inclusion and 1 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 25 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
observation of quality of treatment (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Apr 2016.