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

Primary Purpose

Osteonecrosis Due to Drugs, Jaw

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Topical Phenytoin 5%

About this trial

This is an interventional treatment trial for Osteonecrosis Due to Drugs, Jaw focused on measuring osteonecrosis, mandible

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

control group

treatment group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Soft tissue healing

Appropriate soft tissue healing was defined when no dehiscence occurred

Soft tissue healing

Appropriate soft tissue healing was defined when no dehiscence occurred

Soft tissue healing

Appropriate soft tissue healing was defined when no dehiscence occurred

Pain

Based on visual analogue scale 0-10

Pain

Based on visual analogue scale 0-10

Secondary Outcome Measures

Infection

Any sign of pus or fistula tract in treatment area

Infection

Any sign of pus or fistula tract in treatment area

Infection

Any sign of pus or fistula tract in treatment area

Full Information

NCT ID

NCT03269214

First Posted

August 27, 2017

Last Updated

August 31, 2017

Sponsor

Shiraz University of Medical Sciences

Collaborators

Shahid Beheshti University of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT03269214

Brief Title

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

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Completed

Study Start Date

September 1, 2012 (Actual)

Primary Completion Date

October 31, 2016 (Actual)

Study Completion Date

March 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shiraz University of Medical Sciences

Collaborators

Shahid Beheshti University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteonecrosis Due to Drugs, Jaw

Keywords

osteonecrosis, mandible

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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

Masking

ParticipantInvestigator

Masking Description

Neither patients nor investigators were unaware about treatment and control groups.

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

control group

Arm Type

No Intervention

Arm Description

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

Arm Title

treatment group

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Topical Phenytoin 5%

Intervention Description

Patients received topical Phenytoin 5%+ Tetracycline after necrotic bone debridement .

Primary Outcome Measure Information:

Title

Soft tissue healing

Description

Appropriate soft tissue healing was defined when no dehiscence occurred

Time Frame

After one month

Title

Soft tissue healing

Description

Appropriate soft tissue healing was defined when no dehiscence occurred

Time Frame

Six months after treatment

Title

Soft tissue healing

Description

Appropriate soft tissue healing was defined when no dehiscence occurred

Time Frame

12 months after treatment

Title

Pain

Description

Based on visual analogue scale 0-10

Time Frame

one month after treatment

Title

Pain

Description

Based on visual analogue scale 0-10

Time Frame

Six months after treatment

Secondary Outcome Measure Information:

Title

Infection

Description

Any sign of pus or fistula tract in treatment area

Time Frame

One month after treatment

Title

Infection

Description

Any sign of pus or fistula tract in treatment area

Time Frame

Six months after treatment

Title

Infection

Description

Any sign of pus or fistula tract in treatment area

Time Frame

12 months after treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

We realize final results without any information about individuals who attended in this study

Citations:

PubMed Identifier

35866376

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.

Results Reference

derived

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

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