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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03269214
Enrollment
20
Registered
2017-08-31
Start date
2012-09-01
Completion date
2017-03-30
Last updated
2017-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteonecrosis Due to Drugs, Jaw

Keywords

osteonecrosis, mandible

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.

Interventions

DRUGTopical Phenytoin 5%

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

Sponsors

Shahid Beheshti University of Medical Sciences
CollaboratorOTHER
Shiraz University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Masking description

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

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Soft tissue healingAfter one monthAppropriate soft tissue healing was defined when no dehiscence occurred
Painone month after treatmentBased on visual analogue scale 0-10

Secondary

MeasureTime frameDescription
InfectionOne month after treatmentAny sign of pus or fistula tract in treatment area

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026