Treatment of Medication-related osteonecrosis of the jaw
Design
This study is an interventional study with a comparison of patients before and after. Sampling was done through census and, based on the number of visits, it will include all patients who visit the Maxillofacial Surgery Clinic of Al-Zahra Educational and Medical Center during the study period.
Settings and conduct
This study is an interventional study with a comparison of patients before and after. Sampling was done through census and, based on the number of visits, it will include all patients who visit the Maxillofacial Surgery Clinic of Al-Zahra Educational and Medical Center during the study period.
Participants/Inclusion and exclusion criteria
inclusion criteria: Patients who are diagnosed with stage 1 and 2 drug-related osteonecrosis of the jaw based on their history and clinical symptoms (individuals who have not improved for more than 8 weeks after identification of exposed bone, have a history of taking bisphosphonates or similar drugs, and have not undergone radiotherapy).
Have a history of bisphosphonate/denosumab use.
The patient has not received surgical treatment to improve their lesion in the previous 6 months.
exclusion criteria:Failure to visit regularly for treatment protocol
The patient's malignancy is in an active stage
Unwillingness to continue treatment
Intolerance to medication
Patients with stage 3 drug-induced osteonecrosis of the jaw based on history and clinical symptoms
Death
Stage III patients due to differences in type of surgery and treatment algorithm
Intervention groups
Patients undergo surgical intervention along with low-level laser and vitamin E and pentoxifylline supplementation.
Main outcome variables
Treatment of Medication-related osteonecrosis of the jaw
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221108056446N11
Registration date:2025-01-02, 1403/10/13
Registration timing:prospective
Last update:2025-01-02, 1403/10/13
Update count:0
Registration date
2025-01-02, 1403/10/13
Registrant information
Name
Mehdi Mahmoodkhani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 913 686 3733
Email address
mahmoodkhani@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-01-20, 1403/11/01
Expected recruitment end date
2025-06-22, 1404/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of combination of surgery, Low-Level Laser, vitamin E and Pentoxifylline on treatment of medication Related Osteonecrosis of Jaw
Public title
surgery, Low-Level Laser, vitamin E and Pentoxifylline on treatment of medication Related Osteonecrosis of Jaw
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are diagnosed with stage 1 and 2 drug-related osteonecrosis of the jaw based on their history and clinical symptoms (individuals who have not improved for more than 8 weeks after identification of exposed bone, have a history of taking bisphosphonates or similar drugs, and have not undergone radiotherapy).
Have a history of bisphosphonate/denosumab use.
The patient has not received surgical treatment to improve their lesion in the previous 6 months.
Exclusion criteria:
Failure to visit regularly for treatment protocol
The patient's malignancy is in an active stage
Unwillingness to continue treatment
Intolerance to medication
Patients with stage 3 drug-induced osteonecrosis of the jaw based on history and clinical symptoms
Death
Stage III patients due to differences in type of surgery and treatment algorithm
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
16
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hazar Jarib Street, Azadi Square
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2024-10-14, 1403/07/23
Ethics committee reference number
IR.MUI.DHMT.REC.1403.125
Health conditions studied
1
Description of health condition studied
medication related osteonecrosis of the jaw
ICD-10 code
M87.1
ICD-10 code description
Osteonecrosis due to drugs
Primary outcomes
1
Description
Wound healing
Timepoint
Twice a week for three months after surgery
Method of measurement
Patient examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Antibiotics co-amoxiclav 625 mg three times a day and metronidazole 250 mg three times a day are prescribed from two days before surgery to 7 days after. Then low-level laser two sessions per week and a series of 8 sessions after surgery, chlorhexidine mouthwash 0.2% twice a day for two weeks after surgery, vitamin E 400 units twice a day for three months, pentoxifylline 400 mg twice a day for three months
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-zahra Hospital
Full name of responsible person
Bizhan Movahedian Atar
Street address
Al-Zahra Hospital, Safa Street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 913 267 1849
Email
Ghoraani_h@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Asgari
Street address
Hazar Jarib Street, Azadi Square
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
mui@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
1
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Bizhan Movahedian Atar
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Al-Zahra Hospital, Safa Street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 913 267 1849
Email
Ghoraani_h@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Bizhan Movahedian Atar
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Al-Zahra Hospital, Safa Street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 913 267 1849
Email
Ghoraani_h@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Bizhan Movahedian Atar
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Al-Zahra Hospital, Safa Street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 913 267 1849
Email
Ghoraani_h@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available