Bisphosphonate-Associated Osteonecrosis of the JawPRFNCT02198001
Prospective Randomized Study: Assessment of PRF Efficacy in Prevention of Jaw Osteonecrosis After Tooth Extraction
A study testing tooth extraction with antibiotics (amoxicillin- clavulanate, clindamycine) and atraumatic extraction in people with Bisphosphonate-Associated Osteonecrosis of the Jaw, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 3 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Bisphosphonate-Associated Osteonecrosis of the Jaw
- What is being tested?
- tooth extraction with antibiotics (amoxicillin- clavulanate, clindamycine) and atraumatic extraction
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 3 sitesBelgium
- Study dates
- Jan 2014to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- pregnant women
- younger than 50 years old
- jaw's radiotherapy
- history of jaw osteonecrosis
- jaw metastasis from an other cancer
Trial locations and contacts
3 sites in 1 country.
Dorothée L Deneubourg, MD, DDS contact
Belgium3 sites, 3 recruiting
- Recruiting
Cliniques Universitaires Saint Luc
Brussels, 1200
Michele Magremanne, MD, DDS, 003227645711, michele.magremanne@uclouvain.be
- Recruiting
Centre Hospitaliser Ambroise Paré
Mons, 7000
Catherine Vervaet, MD DDS, 003265414190, catherine.vervaet@hap.be
- Recruiting
Clinique et maternité Sainte Elisabeth
Namur, 5000
Patrice Lejuste, MD, DDS, 003281720631, patrice.lejuste@cmsenamur.be
About this study
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
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.
Read the 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.
- Being tested
- tooth extraction with antibiotics (amoxicillin- clavulanate, clindamycine), atraumatic extraction
- Keywords
- Platelets, fibrin, growth factors, bisphosphonates, tooth extraction
- Medical subject headings
- Bisphosphonate-Associated Osteonecrosis of the Jaw
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tooth extraction with antibiotics (amoxicillin- clavulanate, clindamycine)Drug
Also called antibiotherapy before and after extraction
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
atraumatic extractionProcedure or surgery
Also called - atraumatic tooth extraction, - hermetic mucosal closure
Atraumatic tooth extraction, alveolar bone reduction, hermetic mucosal closure
| Study group | Role | What they receive |
|---|---|---|
| tooth extraction and insertion of PRF | Active comparator | Experimental: Atraumatic tooth extraction with antibiotics( amoxicillin clavulanate combination) .Insertion of PRF membrane in tooth-extraction site. Receives: Drug: tooth extraction with antibiotics (amoxicillin- clavulanate, clindamycine); Procedure: atraumatic extraction |
| No PRF | Placebo comparator | Atraumatic extraction with antibiotic without PRF insertion Receives: Drug: tooth extraction with antibiotics (amoxicillin- clavulanate, clindamycine); Procedure: atraumatic extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2014 (estimated)
- Study startJan 2014
- Primary completionJan 2016 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bisphosphonate-Associated Osteonecrosis of the JawStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hervé P Reychler, MD, DMD, Study chair, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02198001
- Sponsor's protocol ID
- B403201318408
- Acronym
- PRF
- Status last verified
- Jul 2014
- First submitted
- 15 Jul 2014
- Last updated
- 23 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 35866376
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02198001
- Acronym / sponsor ID
- PRF / B403201318408
- Keywords
- Platelets, fibrin, growth factors, bisphosphonates, tooth extraction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 23 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tooth extraction and insertion of PRF | Active comparator | Drug: tooth extraction with antibiotics (amoxicillin- clavulanate, clindamycine), Procedure: atraumatic extractionExperimental: Atraumatic tooth extraction with antibiotics( amoxicillin clavulanate combination) .Insertion of PRF membrane in tooth-extraction site. |
| No PRF | Placebo comparator | Drug: tooth extraction with antibiotics (amoxicillin- clavulanate, clindamycine), Procedure: atraumatic extractionAtraumatic extraction with antibiotic without PRF insertion |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (5 listed)
- pregnant women
- younger than 50 years old
- jaw's radiotherapy
- history of jaw osteonecrosis
- jaw metastasis from an other cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tooth extraction with antibiotics (amoxicillin- clavulanate, clindamycine)Also: antibiotherapy before and after extractionBPs 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 | Drug | No PRF, tooth extraction and insertion of PRF |
| atraumatic extractionAlso: - atraumatic tooth extraction, - hermetic mucosal closureAtraumatic tooth extraction, alveolar bone reduction, hermetic mucosal closure | Procedure or surgery | No PRF, tooth extraction and insertion of PRF |
Primary outcome
Number of jaw osteonecrosis after tooth extraction
Time frame: 1year
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2014.
- Derived from this study: PubMed 35866376Beth-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.
Related trials for Bisphosphonate-Associated Osteonecrosis of the Jaw
Active, not recruiting
Topical Oxygen Therapy for BRONJ
Bisphosphonate Related Osteonecrosis of the Jaws (BRONJ), Oxygen
Active, not recruitingPhase 3
Pentoxifylline and Tocopherol (PENTO) in the Treatment of Medication-related Osteonecrosis of the Jaw (MRONJ)
Medication-related Osteonecrosis of the Jaw, Bisphosphonate-related Osteonecrosis of the Jaw
Not yet recruiting
Piezoeletric Surgery vs Conventional Surgery for Treatment of MRONJ
Bisphosphonate-Associated Osteonecrosis of the Jaw, Osteonecrosis of the Jaw
RecruitingObservational study
Medication Related Osteonecrosis of the Jaws (MRONJ) in a Cohort of Patients Treated by Antiresorptive Drugs
Osteonecrosis of the Jaw, Osteonecrosis Due to Drugs, Jaw
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dorothée L Deneubourg, MD, DDS contact
Hervé P Reychler, MD, DMD study chair
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tooth extraction with antibiotics (amoxicillin- clavulanate, clindamycine) and atraumatic extraction in people with Bisphosphonate-Associated Osteonecrosis of the Jaw, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 3 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dorothée L Deneubourg, MD, DDS (003227645702 ext. 003227645774, dorothee.deneubourg@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of jaw osteonecrosis after tooth extraction (time frame: 1year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02198001, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2014.