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

Primary Purpose

Alveolar Crest

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MBCP gel TM
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional trial for Alveolar Crest focused on measuring Prevention of the reduction of the alveolar crest

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Centre Hospitalier universitaireRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Filling

Without filling

Arm Description

alveoli filling with an injectable calcium phosphate after extraction of mandibular molar or pre molar

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 21, 2008
Last Updated
June 1, 2010
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00740311
Brief Title
Filling of Tooth Sockets With MBCP Gel TM Versus Technical Without Filling
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Unknown status
Study Start Date
November 2007 (undefined)
Primary Completion Date
November 2010 (Anticipated)
Study Completion Date
May 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Nantes University Hospital

4. Oversight

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alveolar Crest
Keywords
Prevention of the reduction of the alveolar crest

7. Study Design

Study Phase
Not Applicable

8. Arms, Groups, and Interventions

Arm Title
Filling
Arm Type
Experimental
Arm Description
alveoli filling with an injectable calcium phosphate after extraction of mandibular molar or pre molar
Arm Title
Without filling
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
MBCP gel TM
Intervention Description
alveoli filling with an injectable calcium phosphate after extraction of mandibular molar or pre molar
Primary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yves Amouriq
Phone
06 08 76 64 45
Email
yves.amouriq@univ-nantes.fr
Facility Information:
Facility Name
Centre Hospitalier universitaire
City
Nantes
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yves Amouriq
Email
yves.amouriq@univ-nantes.fr

12. IPD Sharing Statement

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

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