Clinical trial NCT03269214: Use of Topical Phenytoin in Bisphosphonate-related Osteonecrosis of the Mandible
Official title: Does Topical Phenytoin Enhance Healing Process in Bisphosphonate-related Osteonecrosis of the Mandible. A Uni-blind Clinical Trial Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteonecrosis Due to Drugs, Jaw
Keywords: osteonecrosis
mandible
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Shahid Beheshti University of Medical Sciences
First posted: 2017-08-31
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients who had bisphosphonate-related osteonecrosis of the jaw of the mandible randomly allocated in 2 groups. Group 1 underwent debridement of necrotic bone and the involved area closed primary and in group 2 ,patients received topical Phenytoin 5%+ Tetracycline
Primary purpose: TREATMENT

Brief summary: Patients who had bisphosphonate-related osteonecrosis of the jaw in stage II were allocated in two groups randomly : In group1, 10 patients underwent debridement and primary closer of the area,in group 2 , patients received Phenytoin + tetracycline topically in the debridement area.Wound dehiscence , infection and pain were in 1,6 and 12 months after treatment.

Detailed description: All patients undergo surgical necrotic bone debridement in combination with antibiotic therapy (clindamycin 300 mg q8h) for 4 weeks . Patients who had BRON of the mandible randomly allocated in 2 groups. Group 1 underwent debridement of necrotic bone and the involved area closed primary and in group 2 ,patients received topical Phenytoin 5%+ Tetracycline. Patients were evaluated after 1(time1) ,6(time2) and 12(time 3) months.

The size of bone lesion was measured by using come beam computer tomography (CBCT).

Wound dehiscence (Stage 0 :No dehiscence ,Stage 1: less than 10 mm dehiscence,stage 2 : more than 10 mm dehiscence) Infection: Pus, sinus tract (Yes/NO) Pain according to visual analog scale (VAS) 0-10.In the third follow up time ( 12 months) ,the number of patients who were a time span of 3 months without clinical symptoms were documented in each group.

Eligibility criteria: Inclusion Criteria:

* Criteria of bisphosphonate-related Osteonecrosis in stage II
* need debridement and surgical intervention

Exclusion Criteria:

* Malignancy in the area
* History of chemotherapy ,
* diabetic mellitus
* HIV
* odontogenic infection or undergo dialysis

Primary outcomes:
measure: Soft tissue healing
timeFrame: After one month
measure: Soft tissue healing
timeFrame: Six months after treatment
measure: Soft tissue healing
timeFrame: 12 months after treatment
measure: Pain
timeFrame: one month after treatment
measure: Pain
timeFrame: Six months after treatment
Secondary outcomes:
measure: Infection
timeFrame: One month after treatment
measure: Infection
timeFrame: Six months after treatment
measure: Infection
timeFrame: 12 months after treatment
Other outcomes:
Locations:
Study officials:
References:
citation: 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.