Osteomyelitis of JawNCT07177378
Management of Medication Related Osteonecrosis of the Jaws With Double Periosteal Flap Closure
A study testing management of medication related osteonecrosis of the jaw in people with Osteomyelitis of Jaw, run by Tanta University at 1 site in Egypt.
Trial summary
20 patients with MRONJ underwent surgical debridement using piezosurgery then closure using double periosteal flap Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Osteomyelitis of Jaw
- What is being tested?
- management of medication related osteonecrosis of the jaw
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Jan 2025to 26 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- patients with MRONJ
Who cannot join
- Patients had a history of radiotherapy
- Patients need only conservative treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Management of Medication Related Osteonecrosis of the Jaws Using Piezosurgery With Simultaneous Double Periosteal Flap Closure
20 patients with MRONJ underwent surgical debridement using piezosurgery then closure using double periosteal flap
Read the detailed description
20 patients with MRONJ underwent surgical debridement, crestal incision and oblique releasing incision were performed to expose the area of osteomyelitis, then squesterum was removed using piezosurgery. After complete debridement, the periosteal layer was dissected from mucoperiosteal buccal flap and based superiorly, then turn upward to be sutured to the lingual flap followed by suturing of buccal flap to achieve double layers closure
- Conditions
- Osteomyelitis of Jaw
- Being tested
- management of medication related osteonecrosis of the jaw
- Keywords
- medication related osteonecrosis, mandible, piezosurgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
management of medication related osteonecrosis of the jawDevice
after buccal flap reflection, the bone osteonecrosis was debrided using piezosurgery. the buccal mucoperiosteal flap was dissected to two layers first, the periosteal layer was based superiorly and the mucosal flap to achieve double layers closure.
| Study group | Role | What they receive |
|---|---|---|
| management of medication related osteonecrosis of the jaw | Experimental | The buccal mucoperiosteal flap was elevated to expose the area of osteonecrosis in the mandible. it was debrided using piezosurgery then closure was achieved using double periosteal flap Receives: Device: management of medication related osteonecrosis of the jaw |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluation of pain
visual analog scale (VAS), with 0 indicating no pain and 10 indicating the most severe pain.
Measured: one month
wound healing
the wound healing index (WHI) which scored soft tissue healing according to the following criteria: score 1 = uneventful healing with no gingival edema, erythema, suppuration, patient discomfort, or flap dehiscence; score 2 = uneventful healing with slight gingival edema, erythema, patient discomfort, or flap dehiscence, but no suppuration; and score 3 = poor wound healing with significant gingival edema, erythema, patient discomfort, flap dehiscence, or any suppuration
Measured: one -3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study start3 Jan 2025
- Primary completion18 Nov 2026 (estimated)
- Study completion26 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteomyelitis of JawStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Not applicable
- Intervention model
- Single group
- Model description
- patient with medication related osteonecrosis of the mandible underwent surgical debridement and closure using double periosteal flap
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mona samy sheta, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07177378
- Sponsor's protocol ID
- 1981
- Status last verified
- May 2026
- First submitted
- 15 Sep 2025
- Last updated
- 19 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Medication Related Osteonecrosis of the Jaws Using Piezosurgery With Simultaneous Double Periosteal Flap Closure
- ClinicalTrials.gov ID
- NCT07177378
- Acronym / sponsor ID
- 1981
- Conditions
- Osteomyelitis of Jaw
- Keywords
- medication related osteonecrosis, mandible, piezosurgery
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 3 Jan 2025 (actual)
- Primary completion
- 18 Nov 2026 (estimated)
- Study completion
- 26 Dec 2026 (estimated)
- First posted
- 17 Sep 2025 (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.
20 patients with MRONJ underwent surgical debridement using piezosurgery then closure using double periosteal flap
Detailed description
20 patients with MRONJ underwent surgical debridement, crestal incision and oblique releasing incision were performed to expose the area of osteomyelitis, then squesterum was removed using piezosurgery. After complete debridement, the periosteal layer was dissected from mucoperiosteal buccal flap and based superiorly, then turn upward to be sutured to the lingual flap followed by suturing of buccal flap to achieve double layers closure
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- patient with medication related osteonecrosis of the mandible underwent surgical debridement and closure using double periosteal flap
| Arm | Type | Receives |
|---|---|---|
| management of medication related osteonecrosis of the jaw | Experimental | Device: management of medication related osteonecrosis of the jawThe buccal mucoperiosteal flap was elevated to expose the area of osteonecrosis in the mandible. it was debrided using piezosurgery then closure was achieved using double periosteal flap |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients with MRONJ
Key exclusion criteria (2 listed)
- Patients had a history of radiotherapy
- Patients need only conservative treatment
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 |
|---|---|---|
| management of medication related osteonecrosis of the jawafter buccal flap reflection, the bone osteonecrosis was debrided using piezosurgery. the buccal mucoperiosteal flap was dissected to two layers first, the periosteal layer was based superiorly and the mucosal flap to achieve double layers closure. | Device | management of medication related osteonecrosis of the jaw |
Primary outcome
evaluation of pain
Time frame: one month
visual analog scale (VAS), with 0 indicating no pain and 10 indicating the most severe pain.
wound healing
Time frame: one -3 months
the wound healing index (WHI) which scored soft tissue healing according to the following criteria: score 1 = uneventful healing with no gingival edema, erythema, suppuration, patient discomfort, or flap dehiscence; score 2 = uneventful healing with slight gingival edema, erythema, patient discomfort, or flap dehiscence, but no suppuration; and score 3 = poor wound healing with significant gingival edema, erythema, patient discomfort, flap dehiscence, or any suppuration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing management of medication related osteonecrosis of the jaw in people with Osteomyelitis of Jaw, run by Tanta University at 1 site in Egypt.
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 1 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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?
This study is still under way. Results are not available in the source record yet.
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?
evaluation of pain (time frame: one month). 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?
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 19 May 2026.