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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

Tracking Information
First Submitted Date  ICMJE August 27, 2017
First Posted Date  ICMJE August 31, 2017
Last Update Posted Date September 1, 2017
Actual Study Start Date  ICMJE September 1, 2012
Actual Primary Completion Date October 31, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 31, 2017)
  • Soft tissue healing [ Time Frame: After one month ]
    Appropriate soft tissue healing was defined when no dehiscence occurred
  • Soft tissue healing [ Time Frame: Six months after treatment ]
    Appropriate soft tissue healing was defined when no dehiscence occurred
  • Soft tissue healing [ Time Frame: 12 months after treatment ]
    Appropriate soft tissue healing was defined when no dehiscence occurred
  • Pain [ Time Frame: one month after treatment ]
    Based on visual analogue scale 0-10
  • Pain [ Time Frame: Six months after treatment ]
    Based on visual analogue scale 0-10
Original Primary Outcome Measures  ICMJE
 (submitted: August 30, 2017)
  • Soft tissue healing [ Time Frame: After one month ]
    Appropriate soft tissue healing was defined when no dehiscence occurred
  • Soft tissue healing [ Time Frame: Six months after treatment ]
    Appropriate soft tissue healing was defined when no dehiscence occurred
  • Soft tissue healing [ Time Frame: 12 months after btreatment ]
    Appropriate soft tissue healing was defined when no dehiscence occurred
  • Pain [ Time Frame: one month after treatment ]
    Based on visual analogue scale 0-10
  • Pain [ Time Frame: Six months after treatment ]
    Based on visual analogue scale 0-10
Change History Complete list of historical versions of study NCT03269214 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 30, 2017)
  • Infection [ Time Frame: One month after treatment ]
    Any sign of pus or fistula tract in treatment area
  • Infection [ Time Frame: Six months after treatment ]
    Any sign of pus or fistula tract in treatment area
  • Infection [ Time Frame: 12 months after treatment ]
    Any sign of pus or fistula tract in treatment area
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Use of Topical Phenytoin in Bisphosphonate-related Osteonecrosis of the Mandible
Official Title  ICMJE Does Topical Phenytoin Enhance Healing Process in Bisphosphonate-related Osteonecrosis of the Mandible. A Uni-blind Clinical Trial Study
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Osteonecrosis Due to Drugs, Jaw
Intervention  ICMJE Drug: Topical Phenytoin 5%
Patients received topical Phenytoin 5%+ Tetracycline after necrotic bone debridement .
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Topical Phenytoin 5%
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 30, 2017)
20
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 30, 2017
Actual Primary Completion Date October 31, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03269214
Other Study ID Numbers  ICMJE 1396D22
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: We realize final results without any information about individuals who attended in this study
Responsible Party Reza Tabrizi, Shiraz University of Medical Sciences
Study Sponsor  ICMJE Shiraz University of Medical Sciences
Collaborators  ICMJE Shahid Beheshti University of Medical Sciences
Investigators  ICMJE Not Provided
PRS Account Shiraz University of Medical Sciences
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP