Evaluation of the effect of Ora-aid tissue adhesive on post-operative pain after tooth extraction
Design
A clinical trial with a control group with randomized parallel groups. on 38 patients. A coin is used for randomization
Settings and conduct
Candidates for extraction of both upper first premolar teeth for orthodontic reasons, who were referred from the orthodontic department of Yazd Dental School to the maxillofacial surgery department. The study is not blind because the patient and the doctor see the type of dressing inside the mouth.
Participants/Inclusion and exclusion criteria
inclusion criteria: All patients referred from the Orthodontics Department to the Oral And Maxillofacial Surgery Department of Shahid Sadoughi Faculty of Dentistry, Yazd, who need extraction of both upper 4th premolar teeth.
Exclusion criteria: people with systemic diseases, smoking
Intervention groups
Intervention group: maxillary 4th premolar socket, which was bandaged with ora-aid mucosal adhesive after tooth extraction (made by TBM Korea)
Control group: maxillary 4th premolar socket on the opposite side, which was bandaged with sterile gauze after tooth extraction
Main outcome variables
pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230204057322N1
Registration date:2023-06-23, 1402/04/02
Registration timing:prospective
Last update:2023-06-23, 1402/04/02
Update count:0
Registration date
2023-06-23, 1402/04/02
Registrant information
Name
Mohammad Amin Yektaie
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4467 1315
Email address
m.am.yektaie@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-06, 1402/04/15
Expected recruitment end date
2024-03-15, 1402/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Ora-aid tissue adhesive on post-operative pain after tooth extraction
Public title
Evaluation of pain reduction of Ora-aid tissue adhesive
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
all patients who should extract their upper 4s for orthodontic reasons
patients visited by Oral and Maxillofacial surgery (OMFS) Department of dental faculty at Shahid Sadughi University (SSU)
Exclusion criteria:
having underlying systemic disease
smoking
Age
From 12 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
38
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Simple randomization with coin toss
Randomization unit: left or right side of the mouth
Randomization Tool: Coins
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Dental Faculty of Yazd Shahid Sadughi University of Medical Sciences
Street address
Dental Faculty of Shahid Sadughi University, Fajr Blvd, Yazd
City
Yazd
Province
Yazd
Postal code
8913814396
Approval date
2022-12-12, 1401/09/21
Ethics committee reference number
IR.SSU.DENTISTRY.REC.1401.058
Health conditions studied
1
Description of health condition studied
Post tooth extraction pain
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
pain measurement
Timepoint
5-12-24-48 hours after intervention
Method of measurement
visual analogue scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: in the first session and After extraction, the tooth socket is washed with normal saline and then a mucosal adhesive cut in appropriate size is placed on it (ora-aid mucosal adhesive made by TBM South Korea, including cyanoacrylate polymers and hydroxyethyl cellulose).
Category
Treatment - Drugs
2
Description
Control group: In the second session, after extraction, the tooth socket is washed with normal saline and then dressed with sterile gauze.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Dantal Faculty of Yazd Shahid Sadughi University
Full name of responsible person
Dr Mohsen Barzegar
Street address
Oral and Maxillofacial Department,Dental Faculty,Dahe Fajr blvd,Yazd