Dental Pulp CappingCPDBNCT02891876
3-months Success Rate of Direct Pulp Capping With Biodentine®
An observational study of Dental Pulp Capping, run by University Hospital, Brest at 1 site in France.
Trial summary
Biodentine® is a most recent material for direct pulp capping. The aim of this study is to determine the 3 months success rate (defined as clinical and radiographic successes together) of direct pulp capping realized with Biodentine®. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Dental Pulp Capping
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 27 May 2015to 2 Dec 2016
- Phase
- Observational
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Study population: adult patients with a small pulp exposure (<2mm) created during carie removal on a vital tooth
Who may be able to join
- adult patients with a small pulp exposure (<2mm) created during decy removal on a vital tooth
- absence of spontaneous pain, of fistula, of swelling, of mobility, of periodontal enlargement, of resorption, of periapical pathosis, of furcation defect, on this tooth
- normal periodontal probing around this tooth
- cold vitality test : positive but non increased on this tooth
Who cannot join
- patient with at risk of endocarditis,
- patient with allergic reactions to a product used in the protocol,
- patient with a lack of oral hygiene,
- tooth with spontaneous pain, fistula, swelling, increased mobility, periodontal enlargement, resorption, periapical pathosis, furcation defect, pulpal necrosis, pulpal irreversible inflammation, excessive dental destruction, very abundant pulp bleeding, impossible set-up of the rubber dam
- tooth with a pulp exposure >2mm
Trial locations and contacts
1 site in 1 country.
About this study
Biodentine® is a most recent material for direct pulp capping. The aim of this study is to determine the 3 months success rate (defined as clinical and radiographic successes together) of direct pulp capping realized with Biodentine®.
Read the detailed description
Context : When a pulpal exposure happens on a vital tooth (without irreversible inflammation), direct pulp capping can be realized by using different biomaterials : CaOH2, MTA or Biodentine®. Biodentine® is the most recent material and its success rate for direct pulp capping is poorly documented.
Objective : The main aim of this study is to determine the 3 months success rate (defined as clinical and radiographic successes together) of direct pulp capping realized with Biodentine®. The other aims are to determine the factors which have an influence over the success or the failure of direct pulp capping.
Method : The patient's non-opposition is obtained after a loyal explanation of the study in order to collect clinical data, if a pulpal exposure (<2mm) happens on a vital tooth during decy excavation.
The operator registers the following data: age of the patient, type of the concerned tooth, volume of coronal pulp, surface of the pulp exposure, location, area and duration of pulp bleeding. An evaluation is realized 3 months later with the same clinical evaluation and a radiographic evaluation. If the pulp vitality is normal, the final coronal filling is then realized.
A statistical analysis will be performed to determine the success rate (binomial distribution with p=0.05). The predictive factors of success or failure will be analyzed with a logistic regression (with p=0.05).
- Conditions
- Dental Pulp Capping
- Keywords
- direct pulp capping, biodentine
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment success
Treatment success will be asses only if clinical AND radiographic examination are successful
Measured: 3 months after the dental direct pulp capping
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2016 (estimated)
- Study start27 May 2015
- Primary completion2 Dec 2016
- Study completion2 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Pulp CappingStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02891876
- Sponsor's protocol ID
- CPDB
- Acronym
- CPDB
- Status last verified
- Nov 2017
- First submitted
- 30 Aug 2016
- Last updated
- 29 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3-months Success Rate of Direct Pulp Capping With Biodentine®
- ClinicalTrials.gov ID
- NCT02891876
- Acronym / sponsor ID
- CPDB / CPDB
- Conditions
- Dental Pulp Capping
- Keywords
- direct pulp capping, biodentine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 27 May 2015 (actual)
- Primary completion
- 2 Dec 2016 (actual)
- Study completion
- 2 Dec 2016 (actual)
- First posted
- 8 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.
Biodentine® is a most recent material for direct pulp capping. The aim of this study is to determine the 3 months success rate (defined as clinical and radiographic successes together) of direct pulp capping realized with Biodentine®.
Detailed description
Context : When a pulpal exposure happens on a vital tooth (without irreversible inflammation), direct pulp capping can be realized by using different biomaterials : CaOH2, MTA or Biodentine®. Biodentine® is the most recent material and its success rate for direct pulp capping is poorly documented.
Objective : The main aim of this study is to determine the 3 months success rate (defined as clinical and radiographic successes together) of direct pulp capping realized with Biodentine®. The other aims are to determine the factors which have an influence over the success or the failure of direct pulp capping.
Method : The patient's non-opposition is obtained after a loyal explanation of the study in order to collect clinical data, if a pulpal exposure (<2mm) happens on a vital tooth during decy excavation.
The operator registers the following data: age of the patient, type of the concerned tooth, volume of coronal pulp, surface of the pulp exposure, location, area and duration of pulp bleeding. An evaluation is realized 3 months later with the same clinical evaluation and a radiographic evaluation. If the pulp vitality is normal, the final coronal filling is then realized.
A statistical analysis will be performed to determine the success rate (binomial distribution with p=0.05). The predictive factors of success or failure will be analyzed with a logistic regression (with p=0.05).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- adult patients with a small pulp exposure (<2mm) created during carie removal on a vital tooth
Key inclusion criteria (4 listed)
- adult patients with a small pulp exposure (<2mm) created during decy removal on a vital tooth
- absence of spontaneous pain, of fistula, of swelling, of mobility, of periodontal enlargement, of resorption, of periapical pathosis, of furcation defect, on this tooth
- normal periodontal probing around this tooth
- cold vitality test : positive but non increased on this tooth
Key exclusion criteria (5 listed)
- patient with at risk of endocarditis,
- patient with allergic reactions to a product used in the protocol,
- patient with a lack of oral hygiene,
- tooth with spontaneous pain, fistula, swelling, increased mobility, periodontal enlargement, resorption, periapical pathosis, furcation defect, pulpal necrosis, pulpal irreversible inflammation, excessive dental destruction, very abundant pulp bleeding, impossible set-up of the rubber dam
- tooth with a pulp exposure >2mm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Treatment success
Time frame: 3 months after the dental direct pulp capping
Treatment success will be asses only if clinical AND radiographic examination are successful
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 29 Nov 2017.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Pulp Capping, run by University Hospital, Brest 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 4 inclusion and 5 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 29 Nov 2017. 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?
Treatment success (time frame: 3 months after the dental direct pulp capping). 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 29 Nov 2017.