Evaluation of the effect of ozone therapy on the recovery of patients with drug-induced jaw osteonecrosis
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 0 on 28 patients. Sealed envelopes will be used for randomization.
Settings and conduct
The mentioned plan will be performed on 28 patients in Imam Reza and Ghaem hospitals in Mashhad. The mentioned plan is double-blind.
Participants/Inclusion and exclusion criteria
In this study, 20 patients who are in Stage up to 3 categories related to Medication-related osteonecrosis of the jaw according to the American Society of Oral and Maxillofacial Surgeons are included and randomly divided into two groups.
Intervention groups
fourteen patients randomly selected patients initially between 3 to 10 sessions depending on the stage of the disease or the patient's response to treatment (for 3 consecutive days per week for 3 weeks and one session in the fourth week) (2 syringes of 10 c per day C with a concentration of 25% at the lesion site with a distance of at least 2 cm and a maximum of 4 cm apart. The day after the last ozone treatment session, surgery is performed for the patient. All surgeries and injections are performed by the main executor of the project.
Main outcome variables
The rate of improvement of clinical symptoms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201201049555N1
Registration date:2020-12-06, 1399/09/16
Registration timing:registered_while_recruiting
Last update:2020-12-06, 1399/09/16
Update count:0
Registration date
2020-12-06, 1399/09/16
Registrant information
Name
Majid Eshghpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3841 3492
Email address
eshghpourm@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-13, 1398/08/22
Expected recruitment end date
2021-10-23, 1400/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluate the effectiveness of ozone therapy on recuperation of patient suffering from Medication-related osteonecrosis of the jaw
Public title
Evaluate the effectiveness of ozone therapy on recuperation of patient suffering from Medication-related osteonecrosis of the jaw
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Exposed bone or bone that can be probed through an intraoral or extraoral fistula that remains in the maxillofacial region for more than 8 weeks.
No history of radiotherapy
Possibility of frequent visits for ozone therapy sessions
Exclusion criteria:
Existence of pathological fractures while entering the study
Pregnant patients
Poor prognosis of cancer (with five-year SR less than 10%)
Incidence of pathological fractures in the jaw in the affected area
Perform radiotherapy during the treatment process
Age
No age limit
Gender
Both
Phase
0
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
28
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization. A random sequence is used after using the convenience sampling method. The questionnaire is filled for all referring people on different days of the week until completion the sample size. Then we name the groups A and B, then we put a questionnaire in group A and one in the group .
Blinding (investigator's opinion)
Double blinded
Blinding description
The statistical analyst and the Investigator is different from the surgeon and does not know how to treat (check the recovery rate and clinical symptoms) will be unaware of the intervention and control groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Ghaem Hospital, Ahmad Abad AVE
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Approval date
2019-11-13, 1398/08/22
Ethics committee reference number
IR.MUMS.DENTISTRY.REC.1398.117
Health conditions studied
1
Description of health condition studied
Osteonecrosis
ICD-10 code
M87.1
ICD-10 code description
Osteonecrosis due to drugs
Primary outcomes
1
Description
Tenderness pain
Timepoint
After intervention
Method of measurement
Examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Ozone therapy with surgery for patients with drug-induced osteonecrosis of the jaw
Category
Treatment - Drugs
2
Description
Control group: Traditional debridement and surgery for patients with drug-induced jaw osteonecrosis
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Majid Eshghpour
Street address
Ghaem Hospital, Ahmad Abad AVE
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3841 3492
Email
eshghpourm@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Ghoreishi building, Daneshgah AVE
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3841 2081
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
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
Mashhad University of Medical Sciences
Full name of responsible person
Farnaz Dehabadi
Position
resident
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Ghaem Hospital, Ahmad Abad AVE
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3841 3492
Email
eshghpourm@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Farnaz Dehabadi
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Ghaem Hospital, Ahmad Abad AVE
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3841 3492
Email
DehabadiF961@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Farnaz Dehabadi
Position
resident
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Ghaem Hospital, Ahmad Abad AVE
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3841 3492
Email
DehabadiF961@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
email
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
email
Under which criteria data/document could be used
researchers
From where data/document is obtainable
email
What processes are involved for a request to access data/document