Use of Topical Phenytoin in Bisphosphonate-related Osteonecrosis of the Mandible

Shiraz University of Medical Sciences

Status: Completed

Conditions: Osteonecrosis Due to Drugs, Jaw

Treatments: Drug: Topical Phenytoin 5%

Study type: Interventional

Funder types: Other

Identifiers

NCT03269214

1396D22

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

20 participants in 2 patient groups

control group

No Intervention group

Description:

Patients underwent debridement of necrotic bone and the involved area closed primary

treatment group

Experimental group

Description:

Patients received topical Phenytoin 5%+ Tetracycline after debridement before final closure.

Treatment:

Drug: Topical Phenytoin 5%