Filling of Tooth Sockets With MBCP Gel TM Versus Technical Without Filling

June 1, 2010 updated by: Nantes University Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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),

Exclusion Criteria:

  • 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
  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Filling
alveoli filling with an injectable calcium phosphate after extraction of mandibular molar or pre molar
Device: MBCP gel TM
alveoli filling with an injectable calcium phosphate after extraction of mandibular molar or pre molar
No Intervention: Without filling

What is the study measuring?

Primary Outcome Measures

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Anticipated)

November 1, 2010

Study Completion (Anticipated)

May 1, 2011

Study Registration Dates

First Submitted

August 21, 2008

First Submitted That Met QC Criteria

August 21, 2008

First Posted (Estimate)

August 22, 2008

Study Record Updates

Last Update Posted (Estimate)

June 2, 2010

Last Update Submitted That Met QC Criteria

June 1, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BRD06/9-O

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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