Alveolar CrestNCT00740311
Filling of Tooth Sockets With MBCP Gel TM Versus Technical Without Filling
A study testing MBCP gel TM in people with Alveolar Crest, run by Nantes University Hospital at 1 site in France.
Trial summary
After a dental extraction, the osseous alveoli fill naturally of a blood clot which is transformed some month later into osseous tissues. Even if the alveolar walls remain intact at the end of the intervention, the healing always comes along with a physiological reduction at the level of the site. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Alveolar Crest
- What is being tested?
- MBCP gel TM
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteFrance
- Study dates
- Nov 2007to May 2011
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women, aged from 18 to 75 years, in good general health
- Affiliated to a national insurance scheme or a beneficiary such a regime, having had a preliminary medical examination
- Without clinically significant buccal pathology or significant buccal concomitant treatment
- Presenting at least a mandibular embedded premolar or molar not conservable (maximum 3 molars or premolars not conservable, and no akin tooth),
Who cannot join
- Emergency extraction, or extraction that should not entail an osseous resorption other than a physiological one
- Lacteal tooth
- Trophic lesion
- Acute or chronic osteomyelitis, cellulitis, dry or infectious sachet non treated, granuloma or cyst not treated
- Filling revised surgical site with non resorbable biomaterial waste
- Filling necrotic surgical site
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- Opening of brains
- Past or planned cervicofacial irradiation
- Known addiction to tobacco and alcohol
- Patient that hasn't a sufficient oral hygiene and which could not be better
- Allergy to Spiramycine, Metronidazole, Hydroxyzine, Paracetamol, Dextropropoxyphene, Chlorhexidine, or components of the local anesthesia
- Cancer, non equilibrate diabetes, tuberculosis, evolutionary or non equilibrate infectious or inflammatory disease
- Degenerative osseous pathology
- Distance infection risk
- Immunodeficiency
- Corticoids or other treatment with an effect on phosphocalcic metabolism
- Expectant mothers, parturients and the mothers who nurse (efficient contraception is mandatory).
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier universitaire
Nantes, 44093
Yves Amouriq, yves.amouriq@univ-nantes.fr
About this study
Official title: Comparative Clinical Study of the Prevention of the Reduction of Alveolar Crest by Alveoli Filling With an Injectable Calcium Phosphate After Extraction of Mandibular Molar or Pre Molar
After a dental extraction, the osseous alveoli fill naturally of a blood clot which is transformed some month later into osseous tissues. Even if the alveolar walls remain intact at the end of the intervention, the healing always comes along with a physiological reduction at the level of the site. The reduction of the alveolar crests is a continuous, cumulative and inexorable phenomenon This reduction entails in the long term aesthetic and functional damages which complicate the prosthetic rehabilitation of the dental articulate. That the prosthetic rehabilitation is removable or fixed, implanto-carried or not, it is made more difficult and less comfortable for the patient. In oral surgery, certain pathologies require for their treatment the use of materials of filling generating an activity of reduction / osseous replacement ending in the formation of a physiological calcified neo-tissue. Numerous products of osseous replacement were already used to realize alveolar fillings to avoid this inevitable and strongly harmful osseous loss.The purpose of the present study is to quantify the physiological osseous loss due to the dental extraction with or without filling by a randomized study and with calibrated criteria of evaluation. The current standard of care is no filling (healing from the blood clot) and we know the consecutive osseous loss during the aging. The technique by filling with an osseous substitute is more and more used in Europe and in Asia because of the decrease of the osseous loss. At first, these substitutes were constituted by bone grafts (autografts, allografts, xenografts) that tend to be replaced by synthetic materials. To realize these fillings according to countries, various materials are used (bovine bone, coral, bio glasses, phosphates of calcium). The most used synthetic materials are calcium ortho phosphates, the composition of which is close to mineral phases of calcified tissues. Ceramic of phosphate of calcium and more particularly the Biphasic Phosphate Calcium (BCP) was already used in numerous clinical applications.We chose as this study MBCP gel ™, same product beforehand used in 2 clinical studies for which the Nantes University Hospital was the sponsor.The perspectives of this study are to be able to propose the systematization of the alveolar filling to be able to decrease the osseous reduction after an extraction and to be able to propose more functional prosthetic rehabilitation (improvement of the masticatory power), more aesthetic and comfortable. When we know the effect of the under nutrition due to masticator difficulties notably at the aged persons, we measure all the importance of this major problem of Public health.
- Conditions
- Alveolar Crest
- Being tested
- MBCP gel TM
- Keywords
- Prevention of the reduction of the alveolar crest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBCP gel TMDevice
alveoli filling with an injectable calcium phosphate after extraction of mandibular molar or pre molar
| Study group | Role | What they receive |
|---|---|---|
| Filling | Experimental | alveoli filling with an injectable calcium phosphate after extraction of mandibular molar or pre molar Receives: Device: MBCP gel TM |
| Without filling | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is to compare the reduction of the alveolar crest with or without alveoli filling, verifying if the height of the filled alveolar crests is higher after 3 or 6 month compared to the height of the unfilled alveolar crests.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2008 (estimated)
- Study startNov 2007
- Primary completionNov 2010 (estimated)
- Study completionMay 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar CrestStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00740311
- Sponsor's protocol ID
- BRD06/9-O
- Status last verified
- Jun 2010
- First submitted
- 21 Aug 2008
- Last updated
- 2 Jun 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Clinical Study of the Prevention of the Reduction of Alveolar Crest by Alveoli Filling With an Injectable Calcium Phosphate After Extraction of Mandibular Molar or Pre Molar
- ClinicalTrials.gov ID
- NCT00740311
- Acronym / sponsor ID
- BRD06/9-O
- Conditions
- Alveolar Crest
- Keywords
- Prevention of the reduction of the alveolar crest
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Nov 2010 (estimated)
- Study completion
- May 2011 (estimated)
- First posted
- 22 Aug 2008 (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.
After a dental extraction, the osseous alveoli fill naturally of a blood clot which is transformed some month later into osseous tissues. Even if the alveolar walls remain intact at the end of the intervention, the healing always comes along with a physiological reduction at the level of the site. The reduction of the alveolar crests is a continuous, cumulative and inexorable phenomenon This reduction entails in the long term aesthetic and functional damages which complicate the prosthetic rehabilitation of the dental articulate. That the prosthetic rehabilitation is removable or fixed, implanto-carried or not, it is made more difficult and less comfortable for the patient. In oral surgery, certain pathologies require for their treatment the use of materials of filling generating an activity of reduction / osseous replacement ending in the formation of a physiological calcified neo-tissue. Numerous products of osseous replacement were already used to realize alveolar fillings to avoid this inevitable and strongly harmful osseous loss.The purpose of the present study is to quantify the physiological osseous loss due to the dental extraction with or without filling by a randomized study and with calibrated criteria of evaluation. The current standard of care is no filling (healing from the blood clot) and we know the consecutive osseous loss during the aging. The technique by filling with an osseous substitute is more and more used in Europe and in Asia because of the decrease of the osseous loss. At first, these substitutes were constituted by bone grafts (autografts, allografts, xenografts) that tend to be replaced by synthetic materials. To realize these fillings according to countries, various materials are used (bovine bone, coral, bio glasses, phosphates of calcium). The most used synthetic materials are calcium ortho phosphates, the composition of which is close to mineral phases of calcified tissues. Ceramic of phosphate of calcium and more particularly the Biphasic Phosphate Calcium (BCP) was already used in numerous clinical applications.We chose as this study MBCP gel ™, same product beforehand used in 2 clinical studies for which the Nantes University Hospital was the sponsor.The perspectives of this study are to be able to propose the systematization of the alveolar filling to be able to decrease the osseous reduction after an extraction and to be able to propose more functional prosthetic rehabilitation (improvement of the masticatory power), more aesthetic and comfortable. When we know the effect of the under nutrition due to masticator difficulties notably at the aged persons, we measure all the importance of this major problem of Public health.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Filling | Experimental | Device: MBCP gel TMalveoli filling with an injectable calcium phosphate after extraction of mandibular molar or pre molar |
| Without filling | No intervention | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women, aged from 18 to 75 years, in good general health
- Affiliated to a national insurance scheme or a beneficiary such a regime, having had a preliminary medical examination
- Without clinically significant buccal pathology or significant buccal concomitant treatment
- Presenting at least a mandibular embedded premolar or molar not conservable (maximum 3 molars or premolars not conservable, and no akin tooth),
Key exclusion criteria (17 listed)
- Emergency extraction, or extraction that should not entail an osseous resorption other than a physiological one
- Lacteal tooth
- Trophic lesion
- Acute or chronic osteomyelitis, cellulitis, dry or infectious sachet non treated, granuloma or cyst not treated
- Filling revised surgical site with non resorbable biomaterial waste
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 |
|---|---|---|
| MBCP gel TMalveoli filling with an injectable calcium phosphate after extraction of mandibular molar or pre molar | Device | Filling |
Primary outcome
The primary outcome is to compare the reduction of the alveolar crest with or without alveoli filling, verifying if the height of the filled alveolar crests is higher after 3 or 6 month compared to the height of the unfilled alveolar crests.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2010.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MBCP gel TM in people with Alveolar Crest, run by Nantes University Hospital 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 17 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: status not confirmed, as of the sponsor's last update on 2 Jun 2010. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yves Amouriq (06 08 76 64 45, yves.amouriq@univ-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome is to compare the reduction of the alveolar crest with or without alveoli filling, verifying if the height of the filled alveolar crests is higher after 3 or 6 month compared to the height of the unfilled alveolar crests.. 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 2 Jun 2010.