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

Osteonecrosis Due to Drugs, Jaw Clinical Trial

Official title:

Does Topical Phenytoin Enhance Healing Process in Bisphosphonate-related Osteonecrosis of the Mandible. A Uni-blind Clinical Trial Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03269214
• Other study ID #: 1396D22
• Status: Completed
• Phase: N/A
• First received: August 27, 2017
• Last updated: August 31, 2017
• Start date: September 1, 2012
• Est. completion date: March 30, 2017

Study information

• Verified date: August 2017
• Source: Shiraz University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 30, 2017
• Est. primary completion date: October 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteonecrosis
• Osteonecrosis Due to Drugs, Jaw

Intervention

Drug:
• Topical Phenytoin 5%
Patients received topical Phenytoin 5%+ Tetracycline after necrotic bone debridement .

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Shiraz University of Medical Sciences	Shahid Beheshti University of Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Soft tissue healing	Appropriate soft tissue healing was defined when no dehiscence occurred	After one month
Primary	Soft tissue healing	Appropriate soft tissue healing was defined when no dehiscence occurred	Six months after treatment
Primary	Soft tissue healing	Appropriate soft tissue healing was defined when no dehiscence occurred	12 months after treatment
Primary	Pain	Based on visual analogue scale 0-10	one month after treatment
Primary	Pain	Based on visual analogue scale 0-10	Six months after treatment
Secondary	Infection	Any sign of pus or fistula tract in treatment area	One month after treatment
Secondary	Infection	Any sign of pus or fistula tract in treatment area	Six months after treatment
Secondary	Infection	Any sign of pus or fistula tract in treatment area	12 months after treatment