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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2015 by Centre Hospitalier Régional Metz-Thionville
Information provided by (Responsible Party):
Centre Hospitalier Régional Metz-Thionville Identifier:
First received: January 31, 2012
Last updated: August 27, 2015
Last verified: August 2015
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: June 2017
Estimated Primary Completion Date: June 2016 (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


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

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)
  • 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
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 identifier: NCT01526915

Contact: ERIC GERARD, Dr +33387553641

Chu de Dijon Recruiting
Dijon, France, 21033
Contact: Victorin AHOSSI, Dr    +33380293988   
Scm Bally Curien Recruiting
Maxeville, France, 54320
Contact: Rémi CURIEN, Dr   
Contact: Julien BALLY, Dr   
Chr Metz Thionville Recruiting
Metz, France, 57038
Contact: Eric GERARD, Dr    +33387553641   
Chu de Nancy Recruiting
Nancy, France, 54035
Contact: Julie GUILLET, Dr    +33383682951   
Chu de Reims Recruiting
Reims, France, 51092
Contact: Antoine MATHIEU, Dr    +33326788542   
Sponsors and Collaborators
Centre Hospitalier Régional Metz-Thionville
Principal Investigator: Eric GERARD, Dr CHR Metz Thionville
  More Information

No publications provided

Responsible Party: Centre Hospitalier Régional Metz-Thionville Identifier: NCT01526915     History of Changes
Other Study ID Numbers: RBM 2009-01, 2009-A01003-54
Study First Received: January 31, 2012
Last Updated: August 27, 2015
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Hospitalier Régional Metz-Thionville:

Additional relevant MeSH terms:
Bone Density Conservation Agents
Pharmacologic Actions
Physiological Effects of Drugs processed this record on November 25, 2015