Comparison of the Effect of Ozonized Water with Normal Saline on pain after third Mandibular occult surgery in patients referred to the Department of Oral and Maxillofacial Surgery, Islamic Azad School of Dentistry, Tehran, 2020
Design
Clinical trial with Control group, with Parallel groups, Double-blind, Randomized, phase 3, on 40 patients. Simple random sampling.
Settings and conduct
Samples are randomly selected from the patients referred to the Oral and Maxillofacial Surgery Department of Tehran Azad Dental School. Patients and surgeons are unaware of the type of detergent used on each side. The desired side and the desired material are selected randomly (coins). The researcher is the controller.
Participants/Inclusion and exclusion criteria
People with Mandibular occult Wisdom Teeth Bilateral, do not have Systemic Disease.
Intervention groups
The impacted mandibular wisdom tooth of the mandible is the side that is washed with Ozonated water is the intervention group and the side that is washed with Normal Saline is the control group.
Main outcome variables
The mean amount of Pain after latent Third Molar Surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210119050080N1
Registration date:2021-02-07, 1399/11/19
Registration timing:registered_while_recruiting
Last update:2021-02-07, 1399/11/19
Update count:0
Registration date
2021-02-07, 1399/11/19
Registrant information
Name
Eshagh Lasemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2256 4571
Email address
elasemi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-19, 1399/10/30
Expected recruitment end date
2021-04-19, 1400/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effect of Ozonized Water and Normal Saline on Postoperative Pain of Impacted mandibular third molars.
Public title
Evaluation of the Effect of Ozonized Water and Normal Saline on Pain after Impacted Wisdom Tooth Surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
People with Mandibular Wisdom Teeth are Bilateral
Exclusion criteria:
No systemic disease
Age
From 18 years old to 35 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
40
More than 1 sample in each individual
Number of samples in each individual:
2
Bilateral Wisdom Teeth of the Mandible
Randomization (investigator's opinion)
Randomized
Randomization description
Simple Randomization Method
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and Surgeon do not know what detergent is used on each side of the surgery. The syringes contain two solutions are similar, that are provided to the surgeon by the researcher.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the School of Dentistry, Tehran Azad University of Medical Sciences
Street address
No.9, Neyestan9 Ave, Pasdaran Ave
City
Tehran
Province
Tehran
Postal code
1946853314
Approval date
2020-09-30, 1399/07/09
Ethics committee reference number
IR.IAU.DENTAL.REC.1399.184
Health conditions studied
1
Description of health condition studied
Pain after Wisdom Tooth Surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain score in the visual analogue scale questionnaire
Timepoint
24-48-72 hours, day 5 and day 7 after surgery
Method of measurement
Using pain visual analogue scale questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Ozonized water is produced with an ozone generator model OZONEDS5 is produced by Nab zist Company with a concentration of 11-12 micrograms per ml. The surgical site is washed with this solution.
Category
Prevention
2
Description
Control group: 0.9% sodium chloride solution (9 g NaCl per liter of water) from Iran Injection and Pharmaceutical Products Company is used to wash the surgical site.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Surgery, Faculty of Dentistry, Islamic Azad University of Tehran
Full name of responsible person
Dr ٍEshagh Lasemi
Street address
No.9, neiestan9 Ave, pasdaran Ave
City
Tehran
Province
Tehran
Postal code
91946853314
Phone
+98 21 2676 2270
Email
elasemi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Arash Azizi
Street address
No.9, neiestan9 Ave, pasdaran Ave
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2676 2270
Email
elasemi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
None applicable
Proportion provided by this source
100
Public or private sector
Private
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
Islamic Azad University
Full name of responsible person
Dr Eshagh Lasemi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No. 9, Neiestan 9 Ave, Pasdaran Ave
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2676 2270
Email
elasemi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Eshagh Lasemi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No.9, Neiestan9 Ave, Pasdaran Ave
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2676 2270
Email
Dr.samanehrahimi.m@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Eshagh Lasemi
Position
Associate professor
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No. 9, Neiestan 9 Ave, Pasdaran Ave
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2676 2270
Fax
Email
elasemi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Title and more details about the data/document
A part of the information, such as information about the main outcome or the like, can be shared.
When the data will become available and for how long
The start of the access period will be 6 to12 months after the results are released.
To whom data/document is available
The data will be available only to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
The data will be available for access to dental research centers, universities and public and private health centers.
From where data/document is obtainable
Applicants can contact the person responsible for the article to receive the information. Dr Eshagh Lasemi, elasemi@yahoo.com 00989123871430 No9, Neistan9 Ave, Pasdaran Ave, Tehran, samaneh Rahimi ,Dr.samanehrahimi.m@gmail.com
What processes are involved for a request to access data/document
ِDemand by email to the person responsible for the article Dr.Eshaq Lasemi.elasemi@yahoo.com