By conducting this research, this scientific and practical question will be answered that the local use of hyaluronic acid compared to the control group, has an effect on the amount of pain reduction and maximum opening of the mouth after extraction of molar teeth.
Design
In the intervention group, 400 mg of hyaluronic acid capsules (made by Sanct Bernhard brand in Iran) mixed with 2 ml of normal saline are placed on Gelfoam (Hemospon model made by Ferrosan or a similar product) and then placed on the wound (5 6). It is sutured using 0.3 chromic thread and a 26 mm needle, and a sterile gauze is placed in the area for half an hour. At least after one month, the patients are called to extract the molar teeth of the lower jaw on the opposite side. In the control group, only 2 ml of normal saline is placed on the gel foam and then placed on the wound. It is sutured using 0.3 chromic thread and a 26 mm needle, and a sterile gauze is placed in the area for half an hour.
Settings and conduct
The patients referred to the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Islamic Azad University of Tehran. The evaluator does not know the type of intervention and the study is conducted in a single blinded manner.
Participants/Inclusion and exclusion criteria
Patients between the ages of 18 and 60, who need to have their molar teeth removed, are included in the study.
Also, patients with vascular or blood disorders, anticoagulants such as aspirin, patients with uncontrolled systemic disorders are excluded from the study.
Intervention groups
The first group (control group) will be treated with placebo and the second group (intervention group) will be treated with hyaluronic acid.
Main outcome variables
The amount of pain reduction and maximum opening of the mouth
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240724062535N1
Registration date:2024-08-11, 1403/05/21
Registration timing:prospective
Last update:2024-08-11, 1403/05/21
Update count:0
Registration date
2024-08-11, 1403/05/21
Registrant information
Name
Mohsen Keyvanloo Shahrestanaki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2256 4571
Email address
zgh.keyvanloo995@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-22, 1403/07/01
Expected recruitment end date
2024-12-21, 1403/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The local effect of hyaluronic acid on pain reduction and mouth opening caused by extraction of molar teeth
Public title
Evaluation of the effect of hyaluronic acid on reducing pain after tooth extraction
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged between 18 and 60 years
Lower molar teeth
bilatral
Exclusion criteria:
Patients with vascular or blood disorders
Users of exogenous corticosteroids and anticoagulants such as aspirin
Patients with a history of asthma and allergies
Patients with uncontrolled systemic disorders
Patients with uncontrolled respiratory, digestive, kidney and lung cardiovascular diseases
Patients with a history of head and neck radiotherapy or chemotherapy, suffering from dry mouth
Pregnant women and nursing mothers
Patients with systemic fungal infections, acute infections and tuberculosis
Age
From 18 years old to 60 years old
Gender
Both
Phase
1
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
17
Randomization (investigator's opinion)
Randomized
Randomization description
A simple randomization method (coin flip) is used to assign patients to two groups. The first group (control group) will be treated with placebo and the second group (intervention group) will be treated with hyaluronic acid.
Blinding (investigator's opinion)
Single blinded
Blinding description
The evaluator does not know the type of intervention performed. The examination is performed through another jaw and face. The study is performed in a single blinded manner.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Dentistry Faculty - Islamic Azad University of Medical Sciences, Tehran
Street address
No. 9, Pasdaran St, Nistan 9th
City
Tehran
Province
Tehran
Postal code
1946853314
Approval date
2024-04-24, 1403/02/05
Ethics committee reference number
IR.IAU.DENTAL.REC.1403.013
Health conditions studied
1
Description of health condition studied
extraction of mandibular molar teeth
ICD-10 code
M27.2
ICD-10 code description
Inflammatory conditions of jaws
Primary outcomes
1
Description
The amount of pain
Timepoint
Time intervals of one hour, six hours, twelve hours, twenty-four hours, forty-eight hours, and seventy-two hours after surgical treatment for pain in both control and control sides
Method of measurement
The way to measure pain is based on the VAS criterion.
2
Description
Maximum mouth opening
Timepoint
Time intervals of one day, three days and seven days after surgical treatment, the amount of maximum mouth opening in millimeters on both control and control sides.
Method of measurement
The maximum opening of the mouth is in millimeters and by telephone.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: In the intervention group, 400 mg of hyaluronic acid capsules (made by Sanct Bernhard brand in Iran) mixed with 2 ml of normal saline are placed on Gelfoam (Hemospon model made by Ferrosan or a similar product) and then placed on the wound. be (5,6). It is sutured using 0.3 chromic thread and a 26 mm needle, and a sterile gauze is placed in the area for half an hour. At least after one month, the patients are called to extract the molar teeth of the lower jaw on the opposite side.
Category
Prevention
2
Description
Control group: Control group: In the control group, only 2 ml of normal saline is placed on gelfoam and then placed on the wound. It is sutured using 0.3 chromic thread and a 26 mm needle, and a sterile gauze is placed in the area for half an hour (5,6). Patients will be called for follow-up on the seventh day after surgery to check the response of hyaluronic acid at the tooth extraction site.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Azad Islamic University of Medical Sciences, Faculty of Dentistry, Tehran branch
Full name of responsible person
Farhad Noravesh
Street address
No. 9, Pasdaran St, Nistan 9th
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
farhadnoravesh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farhad Noravesh
Street address
No. 9, Pasdaran St, Nistan 9th
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
farhadnoravesh@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
Farhad Noravesh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No. 9, Pasdaran St, Nistan 9th
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
farhadnoravesh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farhad Noravesh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No. 9, Pasdaran St, Nistan 9th
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
farhadnoravesh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farhad Noravesh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No. 9, Pasdaran St, Nistan 9th
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
farhadnoravesh@gmail.com
Web page address
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