Investigating the effect of iodine tampon on the pain level after partially-impacted mandibular third molar surgery
Design
Split-mouth randomized single blind clinical trial. The random allocation of samples to study groups is done using random blocks of 4.
Settings and conduct
This study is conducted in the Faculty of Dentistry, Islamic Azad University of Tehran. After the extraction of the tooth, the studied interventions are applied. During one week after the surgery, the participants enter their pain score in the questionnaire and after collecting the questionnaire, the information is evaluated. The person evaluating the information is blind to the intervention.
Participants/Inclusion and exclusion criteria
Inclusion condition
The participant should have bilateral- partially-impactd mandibular third molar, no systemic problems, and be between 18 to 30 years old.
Exclusion condition
Smoking, the participant's allergy to the substances used in the study, pregnancy and systemic problems of the participant make t excluded from the study.
Intervention groups
In the experimental group, iodine tampon and then a gauze is placed on it at the surgical site. In the control group, gauze impregnated with physiological serum is placed at the surgical site.
Main outcome variables
Pain level after dental surgery during one week
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231221060486N1
Registration date:2024-02-06, 1402/11/17
Registration timing:prospective
Last update:2024-02-06, 1402/11/17
Update count:0
Registration date
2024-02-06, 1402/11/17
Registrant information
Name
Amir arsalan Yazdani boroujeni
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8802 6163
Email address
arsalan.yazdani1378@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-19, 1402/11/30
Expected recruitment end date
2024-07-21, 1403/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of iodine tampon usage on pain after partially-impacted mandibular third molar surgery
Public title
Evaluation the effect of iodine tampon usage on pain after wisdom tooth surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Mesioangular bilateral partially-impacted mandibular third molar
The patient should be placed in the systemic classification of class 1.
The patient should be between 18 to 30 years old.
Exclusion criteria:
The patient's allergy to ibuprofen
The patient's allergy to iodine
Smoking and tobacco usage
Presence of systemic disease
Presence of acute perichronitis
Presence of periodontal disease
The patient recently or currently has a stomach ulcer
The patient receives anticoagulation treatment
Pregnancy or breastfeeding of the patient
The patient has a history of local infection before surgery in the last 15 days
History of radiotherapy in the jaw and face area
Pathological disease related to the third molar
Age
From 18 years old to 30 years old
Gender
Both
Phase
3
Groups that have been masked
Investigator
Outcome assessor
Sample size
Target sample size:
35
More than 1 sample in each individual
Number of samples in each individual:
2
One tooth as the control group and the other tooth as the intervention group
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the random allocation of samples to study groups is done using random blocks of 4. The randomization process is done by using a table of random numbers and by someone other than the person conducting the study. The type of allocation is noted in a note inside the numbered sealed envelopes. At the first visit of each patient, the envelopes are opened in the order of patients' visits after the end of tooth extraction, and the type of post-operative care is determined based on the intervention mentioned in the note inside each patient's envelope. According to the intervention, the intervention of the opposite tooth will also be determined.
Blinding (investigator's opinion)
Single blinded
Blinding description
The main researcher and the evaluator, who are the same person, are blind to the intervention and do not know what intervention was done on the tooth. This person only evaluates the data collected from the questionnaires.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University Tehran Medical sciences Dental Branch
Street address
4th Floor , No. 25 , 17th St. , Jahan are St. , Yousef Abad
City
Tehran
Province
Tehran
Postal code
1438696845
Approval date
2023-10-30, 1402/08/08
Ethics committee reference number
IR.IAU.DENTAL.REC.1402.110
Health conditions studied
1
Description of health condition studied
Partially-impacted mandibular third molar
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain score in visual analog scale (VAS) pain assessment
Timepoint
Pain score during the first week after surgery
Method of measurement
Visual analog scale (VAS) pain assessment
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After tooth extraction, iodine tampon and then a gauze on it will be placed in the surgical site.
Category
Treatment - Drugs
2
Description
Control group: Gauze impregnated with physiological serum is placed in the surgical site
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Islamic Azad University, Tehran Dental Branch
Full name of responsible person
Amirarsalan Yazdani Boroujeni
Street address
No.9, 9th Neyestan St., Pasdaran Ave.
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
arsalan.yazdani1378@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Arash Azizi
Street address
No.9, 9th Neyestan St., Pasdaran Ave.
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
arsalan.yazdani1378@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Amirarsalan Yazdani Boroujeni
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
4th Floor , No. 25 , 17th St. , Jahan are St. , Yousef Abad
City
Tehran
Province
Tehran
Postal code
1438696845
Phone
+98 21 8802 6163
Email
arsalan.yazdani1378@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Amirarsalan Yazdani Boroujeni
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
4th Floor , No. 25 , 17th St. , Jahan are St. , Yousef Abad
City
Tehran
Province
Tehran
Postal code
1438696845
Phone
+98 21 8802 6163
Email
arsalan.yazdani1378@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Amirarsalan Yazdani Boroujeni
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
4th Floor , No. 25 , 17th St. , Jahan are St. , Yousef Abad
City
Tehran
Province
Tehran
Postal code
1438696845
Phone
+98 21 8802 6163
Email
arsalan.yazdani1378@gmail.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