Prospective Randomized Study: Assessment of PRF Efficacy in Prevention of Jaw Osteonecrosis After Tooth Extraction (PRF)
Primary Purpose
Bisphosphonate-Associated Osteonecrosis of the Jaw
Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
tooth extraction with antibiotics (amoxicillin- clavulanate, clindamycine)
atraumatic extraction
Sponsored by
About this trial
This is an interventional prevention trial for Bisphosphonate-Associated Osteonecrosis of the Jaw focused on measuring Platelets, fibrin, growth factors, bisphosphonates, tooth extraction
Eligibility Criteria
Inclusion Criteria:
- patients taking bisphosphonates whatever the indication, the type, the administration and the duration of treatment (we include patients taking or having taken bisphosphonates, even several years ago)
- And who need tooth extraction (not recoverable in conservative dentistry and symptomatic tooth: dental and periodontal infections, symptomatic traumatic tooth fracture).
Exclusion Criteria:
- pregnant women
- younger than 50 years old
- jaw's radiotherapy
- history of jaw osteonecrosis
- jaw metastasis from an other cancer
Sites / Locations
- Cliniques Universitaires Saint LucRecruiting
- Centre Hospitaliser Ambroise ParéRecruiting
- Clinique et maternité Sainte ElisabethRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
tooth extraction and insertion of PRF
No PRF
Arm Description
Experimental: Atraumatic tooth extraction with antibiotics( amoxicillin clavulanate combination) .Insertion of PRF membrane in tooth-extraction site.
Atraumatic extraction with antibiotic without PRF insertion
Outcomes
Primary Outcome Measures
Number of jaw osteonecrosis after tooth extraction
7 symptoms > 6 weeks for the diagnosis of osteonecrosis:
bone exposure
bone spicule
mucosal inflammation
pain
paresthésias
suppuration
jaw fracture
number of jaw osteonecrosis after tooth extraction in the oral bisphosphonates group in comparison with the IV bisphosphonates group
Secondary Outcome Measures
Full Information
NCT ID
NCT02198001
First Posted
July 15, 2014
Last Updated
July 22, 2014
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1. Study Identification
Unique Protocol Identification Number
NCT02198001
Brief Title
Prospective Randomized Study: Assessment of PRF Efficacy in Prevention of Jaw Osteonecrosis After Tooth Extraction
Acronym
PRF
Official Title
Prospective Randomized Clinical Study: Role of Platelet Rich Fibrin (PRF) in the Tooth Extraction Site in the Prevention of Jaw Osteonecrosis on Patients Under Bisphosphonates Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
January 2016 (Anticipated)
Study Completion Date
January 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This prospective study will include patients taking or having taken bisphosphonates and needing dental extractions.
The aim of this study is to validate the contribution of PRF (Platelet Rich Fibrin) in tooth extraction sites.
In the test group (PRF) and in the control group (no PRF), we use the same atraumatic extraction protocol associated with the same antibiotic procedure.
Detailed Description
Dental extractions are the main cause of jaw osteonecrosis in patients taking oral or iv bisphosphonates.
This prospective randomized study will include a cohort of 100 patients treated with bisphosphonates (for benign or malignant conditions) and requiring dental extractions (non-retainable teeth for infectious, traumatic or parodontal reasons). 50 patients will benefit of PRF placement in the tooth extraction site (group 1) while 50 patients do not (group 2).
The rest of the procedure will be the same in the 2 arms. In the literature, studies suggest a benefit from a long term antibiotherapy before and after tooth extraction. Extraction procedure should be the least traumatic as possible.
The main objective of our study is to assess, after tooth extraction, the contribution of PRF in the prevention of jaw osteonecrosis induced by bisphosphonates.
A follow-up period of one year after extraction is indicated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bisphosphonate-Associated Osteonecrosis of the Jaw
Keywords
Platelets, fibrin, growth factors, bisphosphonates, tooth extraction
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
tooth extraction and insertion of PRF
Arm Type
Active Comparator
Arm Description
Experimental: Atraumatic tooth extraction with antibiotics( amoxicillin clavulanate combination) .Insertion of PRF membrane in tooth-extraction site.
Arm Title
No PRF
Arm Type
Placebo Comparator
Arm Description
Atraumatic extraction with antibiotic without PRF insertion
Intervention Type
Drug
Intervention Name(s)
tooth extraction with antibiotics (amoxicillin- clavulanate, clindamycine)
Other Intervention Name(s)
antibiotherapy before and after extraction
Intervention Description
BPs per os< 3ans: amoxicillin- clavulanate J-1 à J+10
BPs IV ou per os> 3ans ou per os + comordibities (diabetes, immunosuppression, tobacco):
amoxicillin- clavulanate J-3 à J+10
In case of allergy:
BPs per os: clindamycine J-1 à J+10
BPs IV ou per os> 3ans ou per os + comordibities (diabetes, immunosuppression, tobacco):
clindamycine J-3 à J+10
Intervention Type
Procedure
Intervention Name(s)
atraumatic extraction
Other Intervention Name(s)
- atraumatic tooth extraction, - hermetic mucosal closure
Intervention Description
Atraumatic tooth extraction, alveolar bone reduction, hermetic mucosal closure
Primary Outcome Measure Information:
Title
Number of jaw osteonecrosis after tooth extraction
Description
7 symptoms > 6 weeks for the diagnosis of osteonecrosis:
bone exposure
bone spicule
mucosal inflammation
pain
paresthésias
suppuration
jaw fracture
number of jaw osteonecrosis after tooth extraction in the oral bisphosphonates group in comparison with the IV bisphosphonates group
Time Frame
1year
Other Pre-specified Outcome Measures:
Title
Contribution of comorbidities factors in the appearance of osteonecrosis
Description
comorbidities:
diabetes,
immunosuppression (corticoids, chemotherapy, immunosuppressive treatment)
tobacco
Time Frame
1 year
Title
Number of days in tooth-extraction healing in the two groups
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients taking bisphosphonates whatever the indication, the type, the administration and the duration of treatment (we include patients taking or having taken bisphosphonates, even several years ago)
And who need tooth extraction (not recoverable in conservative dentistry and symptomatic tooth: dental and periodontal infections, symptomatic traumatic tooth fracture).
Exclusion Criteria:
pregnant women
younger than 50 years old
jaw's radiotherapy
history of jaw osteonecrosis
jaw metastasis from an other cancer
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dorothée L Deneubourg, MD, DDS
Phone
003227645702
Ext
003227645774
Email
dorothee.deneubourg@uclouvain.be
First Name & Middle Initial & Last Name or Official Title & Degree
Michèle Magremanne, MD, DDS
Phone
003227645711
Email
michele.magremanne@uclouvain.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hervé P Reychler, MD, DMD
Organizational Affiliation
Cliniques universitaires Saint-Luc
Official's Role
Study Chair
Facility Information:
Facility Name
Cliniques Universitaires Saint Luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michele Magremanne, MD, DDS
Phone
003227645711
Email
michele.magremanne@uclouvain.be
Facility Name
Centre Hospitaliser Ambroise Paré
City
Mons
ZIP/Postal Code
7000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine Vervaet, MD DDS
Phone
003265414190
Email
catherine.vervaet@hap.be
Facility Name
Clinique et maternité Sainte Elisabeth
City
Namur
ZIP/Postal Code
5000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrice Lejuste, MD, DDS
Phone
003281720631
Email
patrice.lejuste@cmsenamur.be
12. IPD Sharing Statement
Citations:
PubMed Identifier
35866376
Citation
Beth-Tasdogan NH, Mayer B, Hussein H, Zolk O, Peter JU. Interventions for managing medication-related osteonecrosis of the jaw. Cochrane Database Syst Rev. 2022 Jul 12;7(7):CD012432. doi: 10.1002/14651858.CD012432.pub3.
Results Reference
derived
Learn more about this trial
Prospective Randomized Study: Assessment of PRF Efficacy in Prevention of Jaw Osteonecrosis After Tooth Extraction
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