Trial record 10 of 11 for:    Open Studies | "Raynaud Disease"

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Nantes University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT00740311
First received: August 21, 2008
Last updated: June 1, 2010
Last verified: June 2010
  Purpose

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.


Condition Intervention
Alveolar Crest
Device: MBCP gel TM

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

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. [ Designated as safety issue: No ]

Study Start Date: November 2007
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00740311

Contacts
Contact: Yves Amouriq 06 08 76 64 45 yves.amouriq@univ-nantes.fr

Locations
France
Centre Hospitalier universitaire Recruiting
Nantes, France, 44093
Contact: Yves Amouriq       yves.amouriq@univ-nantes.fr   
Sponsors and Collaborators
Nantes University Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00740311     History of Changes
Other Study ID Numbers: BRD06/9-O
Study First Received: August 21, 2008
Last Updated: June 1, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Nantes University Hospital:
Prevention of the reduction of the alveolar crest

Additional relevant MeSH terms:
Raynaud Disease
CREST Syndrome
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases
Telangiectasis
Scleroderma, Limited
Scleroderma, Systemic
Connective Tissue Diseases
Skin Diseases
Calcinosis
Calcium Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on July 29, 2014