Management of Medication Related Osteonecrosis of the Jaws With Double Periosteal Flap Closure

NCT07177378 | Enrolling By Invitation

• 1 other identifier: 1981
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

20 patients with MRONJ underwent surgical debridement using piezosurgery then closure using double periosteal flap

Conditions

Osteomyelitis of Jaw

Keywords

medication related osteonecrosis; mandible; piezosurgery

Outcome Measures

Primary Outcomes (2)

• evaluation of pain

  visual analog scale (VAS), with 0 indicating no pain and 10 indicating the most severe pain.

  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

  one -3 months

Study Arms (1)

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

Device: management of medication related osteonecrosis of the jaw

Interventions

management of medication related osteonecrosis of the jaw DEVICE

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.

management of medication related osteonecrosis of the jaw

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with MRONJ

You may not qualify if:

• patients had a history of radiotherapy Patients need only conservative treatment

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Faculty of Dentistry, Tanta University

Tanta, 3111, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of oral and maxillofacial surgery

Model Details: patient with medication related osteonecrosis of the mandible underwent surgical debridement and closure using double periosteal flap

Study Record Dates

• First Submitted: September 15, 2025
• First Posted: September 17, 2025
• Study Start: January 3, 2025
• Primary Completion (Estimated): November 18, 2026
• Study Completion (Estimated): December 26, 2026
• Last Updated: September 17, 2025

Record last verified: 2025-09

Locations

EG (1)