Evaluation the effect of tissue adhesive and suture techniques on the postoperative pain after the tooth extraction
Design
The clinical trial consisted of two randomized double-blind parallel groups on 18 patients. Random allocation Software version 1 was used for randomization.
Settings and conduct
At Yazd school of dentistry, either the left or right premolar will be randomly extracted by a surgical resident, then it will be sutured using 3.0 Silk thread (Supasil Co., made in Iran). In order to measure the pain intensity after the surgery, each patient will be given a visual analogue scale (VAS) form to complete. The patient will be asked to record their pain intensity on a chart at 5, 12, 24 and 48 hours after the tooth extraction.
After two weeks, the patient will be required to attend the school for following steps of the treatment. The patient’s first premolar on the other side will be extracted by the resident and the silent tooth will be covered with mucous adhesive. The VAS form will be returned to the patient to record their pain intensity 5, 12, 24 and 48 hours later.
Participants/Inclusion and exclusion criteria
Inclusion criteria : People without systemic disease - No history of allergic to any drugs - With good oral hygiene. At first written consent will be obtained from the patient.
Exclusion criteria: Fear of dentistry
Intervention groups
Intervention group 1:Mucosal adhesive
Intervention group 2:Suture
Main outcome variables
Pain intensity is the main variable which will be measured based on the Visual Analogue Scale at 5-12-24 and 48 hours after tooth extraction.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210306050604N1
Registration date:2021-06-29, 1400/04/08
Registration timing:retrospective
Last update:2021-06-29, 1400/04/08
Update count:0
Registration date
2021-06-29, 1400/04/08
Registrant information
Name
Mohsen Barzegar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3820 8342
Email address
m.barzegar@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-12, 1400/01/23
Expected recruitment end date
2021-04-13, 1400/01/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of tissue adhesive and suture techniques on the postoperative pain after the tooth extraction
Public title
Evaluation of the effect of tissue adhesive and suture on the postoperative pain
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
People without systemic diseases
No history of allergies to any drugs
With good oral hygiene
At first written consent will be obtained from the patient
Exclusion criteria:
Fear of extraction teeth
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
18
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 18 qualified patients will be selected. For each patient, the first premolars will be extracted in the first session and the first premolars on the opposite side of the same jaw will be extracted in the second session and additionally the wound will be covered with sutures or mucosal adhesive. All the patients will be numbered (1 to 18). First, using Random allocation software version 1 and block random allocation method, we will determine the random sequence for numbers 1 to 18. For each number, either the mucosal adhesive (A) or sutures (B) interventions will be applied either in the first turn or in the second turn. Totally, 18 pair blocks (an A&B pair block for each patient) will be identified. In order to blind the random allocation, the random allocation list will be given a third party who knows nothing about the interventions and will be asked on the phone to choose intervention A or B for the patient.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to blind the study in both directions, the patient and the statistical consultant will not know which side of the tooth is pulled at each stage and which technique is used to cover the wound.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Sadouqi School of Yazd Dentistry
Street address
Dahe Fajr Ave,Shahid Sadouqi School of Dentistry of Yazd
City
Yazd
Province
Yazd
Postal code
8914881167
Approval date
2020-06-22, 1399/04/02
Ethics committee reference number
IR.SSU.REC.1399.066
Health conditions studied
1
Description of health condition studied
Evaluation of the effect of tissue adhesive and suture techniques on the postoperative pain after the tooth extraction
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain intensity in patients
Timepoint
5, 12, 24, and 48 hours after tooth extraction.
Method of measurement
By (VAS) Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
First Intervention group: After injection of Lidocaine 2% 1.100000(Darou Pakhsh- Iran), one of premolars on the left or right side will be extracted by a surgical resident and it will be sutured using Supasil (3.0 silk thread made in Supa Medical Devices) according to figure eight.
Category
Treatment - Other
2
Description
Intervention group 2 will attend the school again after two weeks and their first premolar on the other side will be extracted by the resident and the silent tooth will be covered with mucous adhesive. To use mucosal adhesive, first disinfect the wound with normal saline and select the ora-aid mucous adhesive (TBM company, made in South Korea) in the appropriate size. Then dry the wound area with a wet swab, put the adhesive on the silent tooth and press it for 5 to 10 seconds to stick to the wound.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadouqi School of Dentistry of Yazd
Full name of responsible person
Mohsen Barzegar
Street address
Dahe Fajr Ave
City
Yazd
Province
Yazd
Postal code
8914881167
Phone
+98 35 3621 3870
Email
karbalaeaian.ali@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Maryam Kazemipor
Street address
Dahe Fajr Ave
City
Yazd
Province
Yazd
Postal code
8914881167
Phone
+98 35 3621 3870
Email
karbalaeaian.ali@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
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
Yazd University of Medical Sciences
Full name of responsible person
Mohsen Barzegar
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dahe Fajr Ave
City
Yazd
Province
Yazd
Postal code
8914881167
Phone
+98 35 3621 3871
Email
karbakaeaian.ali@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mohsen Barzegar
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dahe Fajr Ave
City
Yazd
Province
Yazd
Postal code
8914881167
Phone
+98 35 3621 3870
Email
karbalaeaian.ali@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mohsen Barzegar
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dahe Fajr Ave
City
Yazd
Province
Yazd
Postal code
8914881167
Phone
+98 35 3621 3870
Email
karbalaeaian.ali@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