Osteonecrosis Due to Drugs, JawNCT03269214
Use of Topical Phenytoin in Bisphosphonate-related Osteonecrosis of the Mandible
A study testing Topical Phenytoin 5% in people with Osteonecrosis Due to Drugs, Jaw, run by Shiraz University of Medical Sciences.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Osteonecrosis Due to Drugs, Jaw
- What is being tested?
- Topical Phenytoin 5%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2012to 30 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Criteria of bisphosphonate-related Osteonecrosis in stage II
- need debridement and surgical intervention
Who cannot join
- Malignancy in the area
- History of chemotherapy ,
- diabetic mellitus
- HIV
- odontogenic infection or undergo dialysis
About this study
Official title: Does Topical Phenytoin Enhance Healing Process in Bisphosphonate-related Osteonecrosis of the Mandible. A Uni-blind Clinical Trial Study
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.
Read the 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.
- Conditions
- Osteonecrosis Due to Drugs, Jaw
- Being tested
- Topical Phenytoin 5%
- Keywords
- osteonecrosis, mandible
- Medical subject headings
- Osteonecrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical Phenytoin 5%Drug
Patients received topical Phenytoin 5%+ Tetracycline after necrotic bone debridement .
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Patients underwent debridement of necrotic bone and the involved area closed primary |
| treatment group | Experimental | Patients received topical Phenytoin 5%+ Tetracycline after debridement before final closure. Receives: Drug: Topical Phenytoin 5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Soft tissue healing
Appropriate soft tissue healing was defined when no dehiscence occurred
Measured: After one month
Soft tissue healing
Appropriate soft tissue healing was defined when no dehiscence occurred
Measured: Six months after treatment
Soft tissue healing
Appropriate soft tissue healing was defined when no dehiscence occurred
Measured: 12 months after treatment
Pain
Based on visual analogue scale 0-10
Measured: one month after treatment
Pain
Based on visual analogue scale 0-10
Measured: Six months after treatment
Secondary outcomes (3)
Infection
Any sign of pus or fistula tract in treatment area
Measured: One month after treatment
Infection
Any sign of pus or fistula tract in treatment area
Measured: Six months after treatment
Infection
Any sign of pus or fistula tract in treatment area
Measured: 12 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2017
- Study start1 Sep 2012
- Primary completion31 Oct 2016
- Study completion30 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteonecrosis Due to Drugs, JawStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shiraz University of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Shahid Beheshti University of Medical Sciences
- Responsible party
- Principal investigator, Reza Tabrizi, Shiraz University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03269214
- Sponsor's protocol ID
- 1396D22
- Status last verified
- Aug 2017
- First submitted
- 27 Aug 2017
- Last updated
- 1 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We realize final results without any information about individuals who attended in this study
Publications
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.
PubMed 35866376
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Topical Phenytoin Enhance Healing Process in Bisphosphonate-related Osteonecrosis of the Mandible. A Uni-blind Clinical Trial Study
- ClinicalTrials.gov ID
- NCT03269214
- Acronym / sponsor ID
- 1396D22
- Conditions
- Osteonecrosis Due to Drugs, Jaw
- Keywords
- osteonecrosis, mandible
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Collaborators
- Shahid Beheshti University of Medical Sciences
- Study start
- 1 Sep 2012 (actual)
- Primary completion
- 31 Oct 2016 (actual)
- Study completion
- 30 Mar 2017 (actual)
- First posted
- 31 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –Patients underwent debridement of necrotic bone and the involved area closed primary |
| treatment group | Experimental | Drug: Topical Phenytoin 5%Patients received topical Phenytoin 5%+ Tetracycline after debridement before final closure. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Criteria of bisphosphonate-related Osteonecrosis in stage II
- need debridement and surgical intervention
Key exclusion criteria (5 listed)
- Malignancy in the area
- History of chemotherapy ,
- diabetic mellitus
- HIV
- odontogenic infection or undergo dialysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topical Phenytoin 5%Patients received topical Phenytoin 5%+ Tetracycline after necrotic bone debridement . | Drug | treatment group |
Primary outcome
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
3 secondary outcomes
Infection
Time frame: One month after treatment
Infection
Time frame: Six months after treatment
Infection
Time frame: 12 months after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2017.
- Derived from this study: PubMed 35866376Beth-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.
- Individual participant dataSharing planned: No. We realize final results without any information about individuals who attended in this study
Related trials for Osteonecrosis Due to Drugs, Jaw
Not yet recruiting
Piezoeletric Surgery vs Conventional Surgery for Treatment of MRONJ
Bisphosphonate-Associated Osteonecrosis of the Jaw, Osteonecrosis of the Jaw
RecruitingObservational study
Medication Related Osteonecrosis of the Jaws (MRONJ) in a Cohort of Patients Treated by Antiresorptive Drugs
Osteonecrosis of the Jaw, Osteonecrosis Due to Drugs, Jaw
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Topical Phenytoin 5% in people with Osteonecrosis Due to Drugs, Jaw, run by Shiraz University of Medical Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Soft tissue healing (time frame: After one month). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03269214, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2017.