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

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ClinicalTrials.gov Identifier: NCT03269214
Recruitment Status : Completed
First Posted : August 31, 2017
Last Update Posted : September 1, 2017
Sponsor:
Collaborator:
Shahid Beheshti University of Medical Sciences
Information provided by (Responsible Party):
Reza Tabrizi, Shiraz University of Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Osteonecrosis Due to Drugs, Jaw Drug: Topical Phenytoin 5% Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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
Masking: Double (Participant, Investigator)
Masking Description: Neither patients nor investigators were unaware about treatment and control groups.
Primary Purpose: Treatment
Official Title: Does Topical Phenytoin Enhance Healing Process in Bisphosphonate-related Osteonecrosis of the Mandible. A Uni-blind Clinical Trial Study
Actual Study Start Date : September 1, 2012
Actual Primary Completion Date : October 31, 2016
Actual Study Completion Date : March 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteonecrosis

Arm Intervention/treatment
No Intervention: control group
Patients underwent debridement of necrotic bone and the involved area closed primary
Experimental: treatment group
Patients received topical Phenytoin 5%+ Tetracycline after debridement before final closure.
Drug: Topical Phenytoin 5%
Patients received topical Phenytoin 5%+ Tetracycline after necrotic bone debridement .




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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Responsible Party: Reza Tabrizi, associate professor of oral and maxillofacial surgery, Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier: NCT03269214     History of Changes
Other Study ID Numbers: 1396D22
First Posted: August 31, 2017    Key Record Dates
Last Update Posted: September 1, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We realize final results without any information about individuals who attended in this study

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Reza Tabrizi, Shiraz University of Medical Sciences:
osteonecrosis
mandible

Additional relevant MeSH terms:
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Phenytoin
Osteonecrosis
Bone Diseases
Musculoskeletal Diseases
Necrosis
Pathologic Processes
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs
Anticonvulsants
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers