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

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ClinicalTrials.gov Identifier: NCT01526915
Recruitment Status : Suspended
First Posted : February 6, 2012
Last Update Posted : April 7, 2017
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Régional Metz-Thionville

Brief Summary:
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 or disease Intervention/treatment
Jawbone Osteochemonecrosis Induced by Bisphosphonates Procedure: Bone curettage + PRF Procedure: Bone curettage alone

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : September 2011
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2017

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Delay in cicatrisation at week 8 [ Time Frame: 8 weeks ]
  2. The appearance of osteochemonecrosis during the follow-up period [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. The characteristics of the received BP treatment: starting date of ongoing treatment, accumulated dose, type of BP, administration route [ Time Frame: 1 year ]
  2. The precise location of the extraction site according to the tooth classification number [ Time Frame: 1 year ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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)
  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01526915


Locations
France
Chu de Dijon
Dijon, France, 21033
Scm Bally Curien
Maxeville, France, 54320
Chr Metz Thionville
Metz, France, 57038
Chu de Nancy
Nancy, France, 54035
Chu de Reims
Reims, France, 51092
Sponsors and Collaborators
Centre Hospitalier Régional Metz-Thionville
Investigators
Principal Investigator: Eric GERARD, Dr CHR Metz Thionville

Responsible Party: Centre Hospitalier Régional Metz-Thionville
ClinicalTrials.gov Identifier: NCT01526915     History of Changes
Other Study ID Numbers: RBM 2009-01
2009-A01003-54 ( Other Identifier: ID RCB - AFSSAPS )
First Posted: February 6, 2012    Key Record Dates
Last Update Posted: April 7, 2017
Last Verified: August 2016

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