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Completed

NCT Number: NCT03269214

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

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.

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Key information

Conditions

Osteonecrosis Due to Drugs, Jaw Bone Diseases Musculoskeletal Diseases Necrosis Osteonecrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Topical Phenytoin 5%

Drug

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

Primary outcomes

  1. Soft tissue healing

    Time frame: After one month

    Appropriate soft tissue healing was defined when no dehiscence occurred

  2. Soft tissue healing

    Time frame: Six months after treatment

    Appropriate soft tissue healing was defined when no dehiscence occurred

  3. Soft tissue healing

    Time frame: 12 months after treatment

    Appropriate soft tissue healing was defined when no dehiscence occurred

  4. Pain

    Time frame: one month after treatment

    Based on visual analogue scale 0-10

  5. Pain

    Time frame: Six months after treatment

    Based on visual analogue scale 0-10

Secondary outcomes

  1. Infection

    Time frame: One month after treatment

    Any sign of pus or fistula tract in treatment area

  2. Infection

    Time frame: Six months after treatment

    Any sign of pus or fistula tract in treatment area

  3. Infection

    Time frame: 12 months after treatment

    Any sign of pus or fistula tract in treatment area

Sponsors and collaborators

Lead sponsor

Shiraz University of Medical Sciences

Other

Collaborators

  • Shahid Beheshti University of Medical Sciences

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2016
Study completion
2017
First posted
Aug 31, 2017
Registry last updated
Sep 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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