Healing Surgical WoundsNCT04531800
Surgical Management of Medication Related Osteonecrosis of the Jaws With Concentrated Growth Factor
A study testing Concentrated growth factor and Non-concentrated growth factor in people with Healing Surgical Wounds and Infection, run by Ege University.
Trial summary
The purpose of this present study was to evaluate the efficiency of the growth factors delivered by concentrated growth factor (CGF) on the healing process of osteoporotic patients with medication-related osteonecrosis of the jaws (MRONJ). Read more about this study
- Who is it for?
- Ages 65 to 85 years, women only
- Conditions the study is for
- Healing Surgical Wounds, Infection
- What is being tested?
- Concentrated growth factor and Non-concentrated growth factor
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2016to 2 Apr 2018
- 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 65 to 85 years
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- treatment with oral bisphosphonates (BPs) for osteoporosis,
- MRONJ diagnosis with exposed bone in the jaws that had persisted for longer than 8 weeks according to 2014 recommendations of the Association of Oral and Maxillofacial Surgeons (AAOMS),
- MRONJ stage 2 or 3 with bone destruction and sequestrum confirmed by clinical and radiographic examination,
- insufficient improvement with conservative treatment.
Who cannot join
- a history of head and neck radiation therapy,
- metastatic bone disease of the jaws,
- platelet values under than 150,000 mm3 in a complete blood count.
About this study
Official title: The Effect of Concentrated Growth Factor (CGF) in Surgical Treatment of Medication-related Osteonecrosis of the Jaw (MRONJ) in Osteoporosis Patients: a Randomized Controlled Study
The purpose of this present study was to evaluate the efficiency of the growth factors delivered by concentrated growth factor (CGF) on the healing process of osteoporotic patients with medication-related osteonecrosis of the jaws (MRONJ).
This randomized controlled study composed of osteoporotic female patients who were treated with oral bisphosphonates (BPs) and diagnosed with MRONJ. For the CGF group, each patient was treated with local application of CGF at the surgical site after removing the necrotic bone while the surgical area was only primarily closed as traditional surgical therapy for the control group. The patients underwent clinical examinations for 6 months postoperatively to check the presence of infection and dehiscence.
Read the detailed description
This randomized controlled study comprised 28 elderly female osteoporotic patients diagnosed with MRONJ at the department of oral and maxillofacial surgery of a university hospital between May 2016 and April 2018.
Before the surgery, the sequentially numbered sealed envelopes were used to randomly assign patients to the study groups:
Study group (14 patients treated with CGF clots + primarily closure) Control group (14 patients treated without CGF placement + primarily closure)
All procedures were performed under local anesthesia by the same surgeon. After removal of superficial bone sequestrum, the necrotic bone was removed with rotating burs, curettage was performed, and the surface of the bone was smoothened (Fig. 2). CGF was then applied to the surgical area in the study group (n=14), and the area was primarily closed after additional releasing incisions were made to the periosteum to assure tension-free soft tissue closure (Fig. 3). In the control group (n=14), the surgical area was only primarily closed without any mobilization of the flap following sequestrectomy and bone curettage as a traditional surgical therapy. A soft diet and daily irrigation with 0.12% chlorhexidine were prescribed for 2 weeks postoperatively. The sutures were removed 14 days postoperatively.
The primary outcome variable of this study was soft tissue healing 6 months post-operatively. The patients underwent weekly clinical examinations for the 1st month and then monthly clinical examinations for 6 months postoperatively. At the time of the evaluation, soft tissue coverage in the surgical site was assessed without signs of infection and/or necrotic bone. The presence of infection was assessed as follows: erythema, swelling, bleeding on probing and purulent exudate. The differences between the study groups were recorded and considered to indicate postoperative healing. BP treatment status and ONJ classification of each patient were recorded and these differences were also assessed in soft tissue healing.
In addition, anamnestic and therapeutic data as patients' age, the type of BPs, timing of medication, location of the exposed necrotic bone and MRONJ-promoting factors were recorded for each patient.
- Conditions
- Healing Surgical Wounds, Infection
- Being tested
- Concentrated growth factor, Non-concentrated growth factor
- Keywords
- osteonecrosis, osteoporosis, concentrated growth factor
- Medical subject headings
- Infections, Osteonecrosis, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concentrated growth factorProcedure or surgery
In the concentrated growth factor (CGF) group, CGF was applied to the surgical area (n=14), and the area was primarily closed after additional releasing incisions.
Non-concentrated growth factorProcedure or surgery
In the non-CGF group, the surgical area was only primarily closed without any mobilization of the flap following sequestrectomy and bone curettage as a traditional surgical therapy.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | The necrotic bone was removed with rotating burs, curettage was performed, and the surface of the bone was smoothened. CGF was then applied to the surgical area in the study group (n=14), and the area was primarily closed after additional releasing incisions were made to the periosteum to assure tension-free soft tissue closure. Receives: Procedure: Concentrated growth factor |
| Control Group | Experimental | The surgical area was only primarily closed without any mobilization of the flap following sequestrectomy and bone curettage as a traditional surgical therapy, in the control group (n=14). Receives: Procedure: Non-concentrated growth factor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Soft tissue healing
Healing was defined as the previous studies. The patients underwent weekly clinical examinations for the 1st month and then monthly clinical examinations for 6 months postoperatively. At the time of the evaluation, soft tissue coverage in the surgical site was assessed without signs of infection and/or necrotic bone. The presence of infection was assessed as follows: erythema, swelling, bleeding on probing and purulent exudate.
Measured: Change of soft tissue healing 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2020
- Study start1 May 2016
- Primary completion26 Mar 2018
- Study completion2 Apr 2018
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 Healing Surgical WoundsStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gözde Işık, Ege University
- Investigators
- Gözde Işık, Principal investigator, Lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04531800
- Sponsor's protocol ID
- School of Dentistry
- Status last verified
- Aug 2020
- First submitted
- 26 Aug 2020
- Last updated
- 31 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 31 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Concentrated Growth Factor (CGF) in Surgical Treatment of Medication-related Osteonecrosis of the Jaw (MRONJ) in Osteoporosis Patients: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04531800
- Acronym / sponsor ID
- School of Dentistry
- Conditions
- Healing Surgical Wounds, Infection
- Keywords
- osteonecrosis, osteoporosis, concentrated growth factor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 1 May 2016 (actual)
- Primary completion
- 26 Mar 2018 (actual)
- Study completion
- 2 Apr 2018 (actual)
- First posted
- 31 Aug 2020 (actual)
- 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 purpose of this present study was to evaluate the efficiency of the growth factors delivered by concentrated growth factor (CGF) on the healing process of osteoporotic patients with medication-related osteonecrosis of the jaws (MRONJ).
This randomized controlled study composed of osteoporotic female patients who were treated with oral bisphosphonates (BPs) and diagnosed with MRONJ. For the CGF group, each patient was treated with local application of CGF at the surgical site after removing the necrotic bone while the surgical area was only primarily closed as traditional surgical therapy for the control group. The patients underwent clinical examinations for 6 months postoperatively to check the presence of infection and dehiscence.
Detailed description
This randomized controlled study comprised 28 elderly female osteoporotic patients diagnosed with MRONJ at the department of oral and maxillofacial surgery of a university hospital between May 2016 and April 2018.
Before the surgery, the sequentially numbered sealed envelopes were used to randomly assign patients to the study groups:
Study group (14 patients treated with CGF clots + primarily closure) Control group (14 patients treated without CGF placement + primarily closure)
All procedures were performed under local anesthesia by the same surgeon. After removal of superficial bone sequestrum, the necrotic bone was removed with rotating burs, curettage was performed, and the surface of the bone was smoothened (Fig. 2). CGF was then applied to the surgical area in the study group (n=14), and the area was primarily closed after additional releasing incisions were made to the periosteum to assure tension-free soft tissue closure (Fig. 3). In the control group (n=14), the surgical area was only primarily closed without any mobilization of the flap following sequestrectomy and bone curettage as a traditional surgical therapy. A soft diet and daily irrigation with 0.12% chlorhexidine were prescribed for 2 weeks postoperatively. The sutures were removed 14 days postoperatively.
The primary outcome variable of this study was soft tissue healing 6 months post-operatively. The patients underwent weekly clinical examinations for the 1st month and then monthly clinical examinations for 6 months postoperatively. At the time of the evaluation, soft tissue coverage in the surgical site was assessed without signs of infection and/or necrotic bone. The presence of infection was assessed as follows: erythema, swelling, bleeding on probing and purulent exudate. The differences between the study groups were recorded and considered to indicate postoperative healing. BP treatment status and ONJ classification of each patient were recorded and these differences were also assessed in soft tissue healing.
In addition, anamnestic and therapeutic data as patients' age, the type of BPs, timing of medication, location of the exposed necrotic bone and MRONJ-promoting factors were recorded for each patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Procedure: Concentrated growth factorThe necrotic bone was removed with rotating burs, curettage was performed, and the surface of the bone was smoothened. CGF was then applied to the surgical area in the study group (n=14), and the area was primarily closed after additional releasing incisions were made to the periosteum to assure tension-free soft tissue closure. |
| Control Group | Experimental | Procedure: Non-concentrated growth factorThe surgical area was only primarily closed without any mobilization of the flap following sequestrectomy and bone curettage as a traditional surgical therapy, in the control group (n=14). |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- treatment with oral bisphosphonates (BPs) for osteoporosis,
- MRONJ diagnosis with exposed bone in the jaws that had persisted for longer than 8 weeks according to 2014 recommendations of the Association of Oral and Maxillofacial Surgeons (AAOMS),
- MRONJ stage 2 or 3 with bone destruction and sequestrum confirmed by clinical and radiographic examination,
- insufficient improvement with conservative treatment.
Key exclusion criteria (3 listed)
- a history of head and neck radiation therapy,
- metastatic bone disease of the jaws,
- platelet values under than 150,000 mm3 in a complete blood count.
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 |
|---|---|---|
| Concentrated growth factorIn the concentrated growth factor (CGF) group, CGF was applied to the surgical area (n=14), and the area was primarily closed after additional releasing incisions. | Procedure or surgery | Study Group |
| Non-concentrated growth factorIn the non-CGF group, the surgical area was only primarily closed without any mobilization of the flap following sequestrectomy and bone curettage as a traditional surgical therapy. | Procedure or surgery | Control Group |
Primary outcome
Soft tissue healing
Time frame: Change of soft tissue healing 6 months postoperatively
Healing was defined as the previous studies. The patients underwent weekly clinical examinations for the 1st month and then monthly clinical examinations for 6 months postoperatively. At the time of the evaluation, soft tissue coverage in the surgical site was assessed without signs of infection and/or necrotic bone. The presence of infection was assessed as follows: erythema, swelling, bleeding on probing and purulent exudate.
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 31 Aug 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.
- Individual participant dataSharing planned: No
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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.
Gözde Işık principal investigator
Lecturer
Questions about this trial
What is this clinical trial studying?
A study testing Concentrated growth factor and Non-concentrated growth factor in people with Healing Surgical Wounds and Infection, run by Ege University.
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 4 inclusion and 3 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 31 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Soft tissue healing (time frame: Change of soft tissue healing 6 months postoperatively). 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 NCT04531800, 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 31 Aug 2020.