Does Topical Phenytoin Enhance Healing Process in Bisphosphonate-related Osteonecrosis of the Mandible. A Uni-blind Clinical Trial Study
Sponsor study identifier
interventional
20
0 countries
N/A
Study Start
September 1, 2012
Actual (reported)Primary Completion
October 31, 2016
Actual (reported)Study Completion
March 30, 2017
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 30, 2017
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 1, 2012
Actual (reported)October 31, 2016
Actual (reported)March 30, 2017
Actual (reported)August 27, 2017
Actual (reported)August 31, 2017
Actual (reported)Soft tissue healing
Appropriate soft tissue healing was defined when no dehiscence occurred
After one month
Soft tissue healing
Appropriate soft tissue healing was defined when no dehiscence occurred
Six months after treatment
Soft tissue healing
Appropriate soft tissue healing was defined when no dehiscence occurred
12 months after treatment
Pain
Based on visual analogue scale 0-10
one month after treatment
Pain
Based on visual analogue scale 0-10
Six months after treatment
Infection
One month after treatment
Infection
Six months after treatment
Infection
12 months after treatment
Patients underwent debridement of necrotic bone and the involved area closed primary
Patients received topical Phenytoin 5%+ Tetracycline after debridement before final closure.
Patients received topical Phenytoin 5%+ Tetracycline after necrotic bone debridement .
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.
20 participants (actual enrollment reported by the registry).
First Submitted
August 27, 2017
First Posted
August 31, 2017
Randomized Trial on the Effect of Topical Phenytoin on Healing After Fistulotomy
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Study Start
September 1, 2012
Actual (reported)Primary Completion
October 31, 2016
Actual (reported)Study Completion
March 30, 2017
Actual (reported)Last Updated
September 1, 2017
Record last verified: 2017-08
We realize final results without any information about individuals who attended in this study
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Source: ClinicalTrials.gov.
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