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Assessment of Platelet Rich Fibrin Efficiency on Healing Delay and on Jawbone Osteochemonecrosis Provoked by Bisphosphonates (OCN/PRF)

This study is currently recruiting participants.
Verified April 2013 by Centre Hospitalier Régional Metz-Thionville
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Régional Metz-Thionville
ClinicalTrials.gov Identifier:
NCT01526915
First received: January 31, 2012
Last updated: April 25, 2013
Last verified: April 2013
History of Changes
  Purpose

The main objective of our study is to assess, after tooth extraction, the efficacity of PRF in the prevention of healing delay and of jawbone osteochemonecrosis induced by bisphosphonates


Condition Intervention
Jawbone Osteochemonecrosis Induced by Bisphosphonates
 Procedure: Bone curettage + PRF
Procedure: Bone curettage alone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Contribution of Platelet Rich Fibrin (PRF) After Tooth Avulsion in the Prevention of Healing Delay and of Jawbone Osteochemonecrosis Induced by Bisphosphonates

Further study details as provided by Centre Hospitalier Régional Metz-Thionville:

Primary Outcome Measures:
  • Delay in cicatrisation at week 8 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • The appearance of osteochemonecrosis during the follow-up period [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The characteristics of the received BP treatment: starting date of ongoing treatment, accumulated dose, type of BP, administration route [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • The precise location of the extraction site according to the tooth classification number [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 270
Study Start Date: January 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bone curettage + PRF
Bone curettage and PRF insertion
 Procedure: Bone curettage + PRF
Bone curettage and PRF insertion
Bone curettage alone
Bone curettage without PRF insertion
 Procedure: Bone curettage alone
Bone curettage without PRF insertion

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient major(male or female)
  • Documented indication at the initial visit at day 0 (JO) for a maximum extraction of 3 teeth.

  • Treatment with nitrogenous or non-nitrogenous BP by intravenous injection or oral administration whichever the reason for this drug prescription:

    • on going BP treatment
    • patient having received a previous treatment with bisphosphonates (irrespective of the duration and withdrawal date of this treatment)
  • Patient having received the specific information letter regarding the study and having signed the clarified consent form.

Exclusion Criteria:

  • Patient having a maxillary or mandibulary OCN at Day 0(JO)
  • Patient presenting an abnormal platlet aggregation test between the selection visit and Day 0 (for patients belonging to the PRF group)
  • Positive HIV serology at Day 0(for patients belonging to the PRF group)
  • Previous history of maxillo-cervico-facial radiotherapy
  • Patients with estimated survival expectancy shorter than one year
  • Lack of social security cover
  • Inability of the patient to respect the study follow-up
  • Patient having reached his/her majority and under tutelage,trusteeship or protection of the court
  • Patient whose diagnosis could not be revealed to him/her (especially when the patient or their family expressed this wish).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01526915

Contacts
Contact: ERIC GERARD, Dr +33387553641 e.gerard@chr-metz-thionville.fr

Locations
France
Chu de Dijon Not yet recruiting
Dijon, France, 21033
Contact: Daniel PERRIN, Dr     +33380293988     daniel.perrin@chu-dijon.fr    
Chr Metz Thionville Recruiting
Metz, France, 57038
Contact: Eric GERARD, Dr     +33387553641     e.gerard@chr-metz-thionville.fr    
Chu de Nancy Not yet recruiting
Nancy, France, 54035
Contact: Pierre BRAVETTI, Dr     +33383682951     pierre.bravetti@odonto.uhp-nancy.fr    
Chu de Reims Not yet recruiting
Reims, France, 51092
Contact: Benoit LEFEVRE, Pr     +33326788542     blefevre@chu-reims.fr    
Sponsors and Collaborators
Centre Hospitalier Régional Metz-Thionville
Investigators
Principal Investigator: Eric GERARD, Dr CHR Metz Thionville
  More Information

No publications provided

Responsible Party: Centre Hospitalier Régional Metz-Thionville
ClinicalTrials.gov Identifier: NCT01526915     History of Changes
Other Study ID Numbers: RBM 2009-01, 2009-A01003-54
Study First Received: January 31, 2012
Last Updated: April 25, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Hospitalier Régional Metz-Thionville:
PRF
PLATELET RICH FIBRIN
BISPHOSPHONATES

Additional relevant MeSH terms:
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013