Jawbone Osteochemonecrosis Induced by BisphosphonatesOCN/PRFNCT01526915
Assessment of Platelet Rich Fibrin Efficiency on Healing Delay and on Jawbone Osteochemonecrosis Provoked by Bisphosphonates
A study testing Bone curettage + PRF and Bone curettage alone in people with Jawbone Osteochemonecrosis Induced by Bisphosphonates, run by Centre Hospitalier Régional Metz-Thionville at 5 sites in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Jawbone Osteochemonecrosis Induced by Bisphosphonates
- What is being tested?
- Bone curettage + PRF and Bone curettage alone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 5 sitesFrance
- Study dates
- Sep 2011to 21 Jun 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Chu de Dijon
Dijon, 21033
Scm Bally Curien
Maxéville, 54320
Chr Metz Thionville
Metz, 57038
Chu de Nancy
Nancy, 54035
Chu de Reims
Reims, 51092
About this study
Official title: Contribution of Platelet Rich Fibrin (PRF) After Tooth Avulsion in the Prevention of Healing Delay and of Jawbone Osteochemonecrosis Induced by Bisphosphonates
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
Read the detailed description
Scientific Context Bisphosphonates (BP) work by slowing down bone remodelling. They are used in the management of different types of cancers and for the treatment of osteoporosis. Recent studies warned that this drug could produce adverse effects on jawbones .In December 2007, the AFSSAPS (French agency for the Sanitary Security of Health Products) alerted the health professionals about the risks of spontaneous or induced osteonecrosis following invasive odontological procedures on patients receiving BP. Prevalence of these osteonecrosis varies from 6% to 10% after surgical intervention. A healing delay estimated between 20 to 25% of cases frequently precedes the occurrence of osteochemonecrosis.
On the whole , the total rate of all complications amounts to 30%. We are extremely limited in terms of prevention or treatment of an OCN patient. We intend to study a biological autologous sediment obtained from a blood sample for its capacity to avoid these complications supervening. The collection of a coagulum called Platelet Rich Fibrin or PRF susceptible to provide the essential ingredients for the mucous membrane and the bone healing is obtained by centrifugation. This biomaterial rich in autologous fibrin is a concentrate of leukocytes, platelets and a number of factors favouring cicatrisation and immune response. Clinical applications are already well documented in orthopaedic, thoracic and cardiac surgeries and, also in dermatology. The use of PRF in dental surgery is more recent. Literature on this topic is very limited but these new techniques give rise to high hopes. Since February 2007,thanks to the classification as a medical treatment by the AFSSAPS, the PRF technique has been authorized.
Objectives To appraise after dental avulsion the PRF efficiency in preventing delay of cicatrisation and jawbone osteochemonecrosis induced by BP.
This efficiency will be assessed by a retroalveolar X-ray performed at each visit. The main criteria for evaluation is the discovery of cicatrisation delay at week 8 and/or osteochemonecrosis during the follow up.
Material and methods
Studied population: current or previous patients treated with BP and referred for a dental avulsion.
General experimental procedure: A prospective, longitudinal, multicentric, randomized open study. Patients will be randomized into two groups: dental avulsion only or dental avulsion and PRF. For both groups the initial management is surgical (bone curettage + PRF for the PRF group).The follow up is spread over one year with 10 visits. Each patient will undergo a clinical and photographic examination with a complete radiological check up(OPT),a standard biological blood test (blood count with haemogram (NFS) and a thorough calculation of the quantity of BP administered. The appearance of OCN or of any delay in cicatrisation will be documented by a histological biopsy, a bacteriological swab test and X-ray.
The requisite number of patients:
270 patients are required to validate the expected objectives in this study. Their recruitment will take place in 4 establishments: Metz-Thionville CHR (Regional Central Hospital) and three university teaching hospitals (CHU) Dijon, Nancy and Reims.
Total Duration of the study :
The estimated total duration will be 3 years: a 2 year recruitment with a 1 year follow-up.
Expected results and prospects To prove the interest of using PRF as a therapy able to prevent a delay in cicatrization or an OCN induced by BP.
- Being tested
- Bone curettage + PRF, Bone curettage alone
- Keywords
- PRF, PLATELET RICH FIBRIN, BISPHOSPHONATES
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone curettage + PRFProcedure or surgery
Bone curettage and PRF insertion
Bone curettage aloneProcedure or surgery
Bone curettage without PRF insertion
| Study group | Role | What they receive |
|---|---|---|
| Bone curettage + PRF | Experimental | Bone curettage and PRF insertion Receives: Procedure: Bone curettage + PRF |
| Bone curettage alone | Other | Bone curettage without PRF insertion Receives: Procedure: Bone curettage alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delay in cicatrisation at week 8
Measured: 8 weeks
The appearance of osteochemonecrosis during the follow-up period
Measured: 1 year
Secondary outcomes (2)
The characteristics of the received BP treatment: starting date of ongoing treatment, accumulated dose, type of BP, administration route
Measured: 1 year
The precise location of the extraction site according to the tooth classification number
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2012 (estimated)
- Study startSep 2011
- Primary completionSep 2016
- Study completion21 Jun 2017
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 Jawbone Osteochemonecrosis Induced by BisphosphonatesStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional Metz-Thionville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric GERARD, Dr, Principal investigator, CHR Metz Thionville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01526915
- Sponsor's protocol ID
- RBM 2009-01
- Other IDs
- 2009-A01003-54
- Acronym
- OCN/PRF
- Status last verified
- Dec 2019
- First submitted
- 31 Jan 2012
- Last updated
- 2 Jan 2020
- 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 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of Platelet Rich Fibrin (PRF) After Tooth Avulsion in the Prevention of Healing Delay and of Jawbone Osteochemonecrosis Induced by Bisphosphonates
- ClinicalTrials.gov ID
- NCT01526915
- Acronym / sponsor ID
- OCN/PRF / RBM 2009-01
- Keywords
- PRF, PLATELET RICH FIBRIN, BISPHOSPHONATES
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional Metz-ThionvilleUniversity, hospital or other
- Study start
- Sep 2011 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- 21 Jun 2017 (actual)
- First posted
- 6 Feb 2012 (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.
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
Detailed description
Scientific Context Bisphosphonates (BP) work by slowing down bone remodelling. They are used in the management of different types of cancers and for the treatment of osteoporosis. Recent studies warned that this drug could produce adverse effects on jawbones .In December 2007, the AFSSAPS (French agency for the Sanitary Security of Health Products) alerted the health professionals about the risks of spontaneous or induced osteonecrosis following invasive odontological procedures on patients receiving BP. Prevalence of these osteonecrosis varies from 6% to 10% after surgical intervention. A healing delay estimated between 20 to 25% of cases frequently precedes the occurrence of osteochemonecrosis.
On the whole , the total rate of all complications amounts to 30%. We are extremely limited in terms of prevention or treatment of an OCN patient. We intend to study a biological autologous sediment obtained from a blood sample for its capacity to avoid these complications supervening. The collection of a coagulum called Platelet Rich Fibrin or PRF susceptible to provide the essential ingredients for the mucous membrane and the bone healing is obtained by centrifugation. This biomaterial rich in autologous fibrin is a concentrate of leukocytes, platelets and a number of factors favouring cicatrisation and immune response. Clinical applications are already well documented in orthopaedic, thoracic and cardiac surgeries and, also in dermatology. The use of PRF in dental surgery is more recent. Literature on this topic is very limited but these new techniques give rise to high hopes. Since February 2007,thanks to the classification as a medical treatment by the AFSSAPS, the PRF technique has been authorized.
Objectives To appraise after dental avulsion the PRF efficiency in preventing delay of cicatrisation and jawbone osteochemonecrosis induced by BP.
This efficiency will be assessed by a retroalveolar X-ray performed at each visit. The main criteria for evaluation is the discovery of cicatrisation delay at week 8 and/or osteochemonecrosis during the follow up.
Material and methods
Studied population: current or previous patients treated with BP and referred for a dental avulsion.
General experimental procedure: A prospective, longitudinal, multicentric, randomized open study. Patients will be randomized into two groups: dental avulsion only or dental avulsion and PRF. For both groups the initial management is surgical (bone curettage + PRF for the PRF group).The follow up is spread over one year with 10 visits. Each patient will undergo a clinical and photographic examination with a complete radiological check up(OPT),a standard biological blood test (blood count with haemogram (NFS) and a thorough calculation of the quantity of BP administered. The appearance of OCN or of any delay in cicatrisation will be documented by a histological biopsy, a bacteriological swab test and X-ray.
The requisite number of patients:
270 patients are required to validate the expected objectives in this study. Their recruitment will take place in 4 establishments: Metz-Thionville CHR (Regional Central Hospital) and three university teaching hospitals (CHU) Dijon, Nancy and Reims.
Total Duration of the study :
The estimated total duration will be 3 years: a 2 year recruitment with a 1 year follow-up.
Expected results and prospects To prove the interest of using PRF as a therapy able to prevent a delay in cicatrization or an OCN induced by BP.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bone curettage + PRF | Experimental | Procedure: Bone curettage + PRFBone curettage and PRF insertion |
| Bone curettage alone | Other | Procedure: Bone curettage aloneBone curettage without PRF insertion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
- Patient having received the specific information letter regarding the study and having signed the clarified consent form.
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| Bone curettage + PRFBone curettage and PRF insertion | Procedure or surgery | Bone curettage + PRF |
| Bone curettage aloneBone curettage without PRF insertion | Procedure or surgery | Bone curettage alone |
Primary outcome
Delay in cicatrisation at week 8
Time frame: 8 weeks
The appearance of osteochemonecrosis during the follow-up period
Time frame: 1 year
2 secondary outcomes
The characteristics of the received BP treatment: starting date of ongoing treatment, accumulated dose, type of BP, administration route
Time frame: 1 year
The precise location of the extraction site according to the tooth classification number
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2020.
- 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.
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.
Eric GERARD, Dr principal investigator
CHR Metz Thionville
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bone curettage + PRF and Bone curettage alone in people with Jawbone Osteochemonecrosis Induced by Bisphosphonates, run by Centre Hospitalier Régional Metz-Thionville at 5 sites in France.
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 6 inclusion and 8 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: finished, as of the sponsor's last update on 2 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delay in cicatrisation at week 8 (time frame: 8 weeks). The study lists 2 primary outcomes in all. 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 NCT01526915, 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 2 Jan 2020.