Protocol summary

Study aim
Investigating the effect of 2% chlorhexidine gel internally on pain after mandibular impacted third molar surgery
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 17 patients, each patient has 2 samples. Randomization using the Excel Randbetween function option
Settings and conduct
This study is conducted in the Faculty of Dentistry of Tehran Azad University in the Department of Oral and Maxillofacial Surgery. researcher and the patient are blinded to the study but clinician is blind. After anesthetic injection, a mucoperiosteal flap will be applied and the tooth will be loosened and removed with an elevator. Chlorhexidine 2% gel will be placed on the tested side, which is randomly selected, along with gelfoam, and gelfoam will be placed on the control side after surgery, then sutures will be applied. It is simple. All patients are given the usual care after surgery (such as painkillers). Demographic data of patients including age, gender, amount of pain while taking painkillers and the number of painkillers used are recorded. The pain level after surgery is evaluated by VAS criteria. Evaluations are performed on both the first and third days after the operation (2, 12, 24, 72 hours after the operation,).
Participants/Inclusion and exclusion criteria
People who are fully satisfied after explaining the procedures and purpose of the research and do not have any specific systemic problems and are 18-25 years old and need bilateral lower third molar surgery.
Intervention groups
Intervention group: Placing 2% chlorhexidine gel in the socket of one side (right or left) of the impacted impacted third molar, control group: Placing placebo on the other side.
Main outcome variables
Pain at 2,12,24,72 hours after surgery on the intervention and control side based on VAS criteria.The VAS is a score from 1-10 , (1: no pain,10: unbearable pain).

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230721058874N1
Registration date: 2023-08-06, 1402/05/15
Registration timing: prospective

Last update: 2023-08-06, 1402/05/15
Update count: 0
Registration date
2023-08-06, 1402/05/15
Registrant information
Name
Alireza Fathi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8897 5068
Email address
arya.fathi77.af@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-01, 1402/07/09
Expected recruitment end date
2023-11-30, 1402/09/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of 2% chlorhexidine gel inside the socket on pain after surgery of the third molar of the mandible.
Public title
Investigating the effect of chlorhexidine on pain after extraction of lower wisdom teeth
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
People who are 18-25 years old. Needs bilateral extraction of mandibular impacted third molar with difficulty level of 7-10 according to Pederson criteria. The mucus on the tooth should be healthy.
Exclusion criteria:
People with a history of systemic diseases, pregnancy, infection in the area, use of anti-coagulant drugs, presence of painful conditions such as teeth needing root canal treatment, neurological diseases and use of nerve drugs, having a history of allergies. People who do not give consent after explaining the steps and purpose of the research.
Age
From 18 years old to 25 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 17
More than 1 sample in each individual
Number of samples in each individual: 2
The right mandibular third molar and the left mandibular third molar
Randomization (investigator's opinion)
Randomized
Randomization description
In each patient, in a simple random manner (by Excel software using the Randbetween function option), the impacted molar tooth on one side is considered as the case group and the other side as the control.
Blinding (investigator's opinion)
Double blinded
Blinding description
Before starting the surgery, the research procedures were explained to the patient, and a consent form was obtained from him or her. On the day of the surgery, the resident (clinician who is not blinded to the study) at Tehran Azad Dental School after surgery and tooth extraction on the Intervention side, which is chosen by simple random before the surgery, he puts chlorhexidine gel and placebo on the control side and writes the information in a form and puts it in a closed envelope and hands it to the researcher. The patient and the researcher, who is the outcome evaluator, are blind, and after evaluating the outcome (which is the evaluation of the patient's pain in each side), he opens the information form and compares and analyzes the data.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Faculty of Dentistry of Tehran Azad University
Street address
south Sohrevardi east Abrar alley No 5
City
Tehran
Province
Tehran
Postal code
1566635111
Approval date
2023-06-14, 1402/03/24
Ethics committee reference number
IR.IAU.DENTAL.REC.1402.029

Health conditions studied

1

Description of health condition studied
Dry socket
ICD-10 code
M27.3
ICD-10 code description
Alveolitis of jaws

2

Description of health condition studied
Impacted teeth
ICD-10 code
K01.1
ICD-10 code description
Impacted teeth

Primary outcomes

1

Description
Pain after impacted mandibular third molar surgery based on Visual Analogue Scale
Timepoint
Pain assessment after 2, 12, 24, 72 hours after surgery, respectively
Method of measurement
Visual Analogue Scale Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: One patient's jaw, which was randomly selected, and after surgery, chlorhexidine gluconate 2% gel Morva Sept, made in Iran, in the amount of 1 ml, was applied to resorable Roeko Gelat Amp gelofoam, made in Germany, and placed in the socket.
Category
Prevention

2

Description
Control group: Roeko Gelat Amp absorbable gel foam made in Germany is placed in the patient's toothless socket after surgery.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Faculty of Dentistry, Azad University of Medical Sciences, Tehran
Full name of responsible person
Eshagh Lasemi
Street address
No 9 . Ninth Neyestan . Pasdaran
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
arya.fathi77@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Arash Azizi
Street address
No 9 . Ninth Neyestan . Pasdaran
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
arya.fathi77@yahoo.con
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
Eshagh Lasemi
Position
Associate professo
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Tehran
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
elasemi@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Eshagh lasemi
Position
Associate professo
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Pasdaran Neyestan 9 alley No 9
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
elasemi@yahoo.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
Specialist
Other areas of specialty/work
Dentistry
Street address
No 9 Ninth Neyestan pasdaran
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
arya.fathi77@yahoo.com

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
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
The research process and the main results of the research and data about the patients are accessible
When the data will become available and for how long
1 year after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions and people working in industry can apply for them
Under which criteria data/document could be used
If the patient is fully satisfied and if it is aimed at improving the patient's condition and preventing the patient's problems, the documents can be used and available
From where data/document is obtainable
You can contact this email for correspondence and exchange of views arya.fathi77.af@gmail.com
What processes are involved for a request to access data/document
It must be for research or treatment
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