Evaluation and comparison of side effects of two suturing methods/simple and horizontal mattress/after mandibular third molar surgery in patients who refer to surgery ward
Determining the intensity of pain and the amount of edema and evaluating the occurrence of dehiscence in two suture models following the impacted wisdom tooth
Design
Patients who meet the criteria for entering the study will be divided into two groups (28 patients with simple suturing, 28 patients with horizontal matrix suturing) by random allocation method using double randomized blocks. They are simplified from suture surgery and the second group is examined with the horizontal matrix method.
Settings and conduct
Patients referring to maxillofacial surgery clinic for implanted wisdom teeth surgery after surgery will be classified according to the type of suture (28 patients sutured by simple method, 28 patients sutured by horizontal matrix method). The first group after simple suture surgery. and the second group is examined with the horizontal matrix method. The patient and the data analyzer do not know about the suture method.
Participants/Inclusion and exclusion criteria
1. Patient consent to participate in the study
2. Absence of systemic disease such as bone pathological conditions, hematological disorders, diabetes
3. Absence of pregnancy and breastfeeding
Intervention groups
The type of suture, which is simple or matrix, matrix intervention group and the control group will receive normal suture
Main outcome variables
Determining the intensity of pain and investigating the factors affecting it; determining the amount of swelling after surgery and investigating the factors affecting it
Clinical observations will be used for each patient to determine the degree of dehiscence and check the factors affecting it.
General information
Reason for update
Acronym
بخیه زدن ساده و ماتریسی
IRCT registration information
IRCT registration number:IRCT20230827059270N1
Registration date:2023-08-31, 1402/06/09
Registration timing:registered_while_recruiting
Last update:2023-08-31, 1402/06/09
Update count:0
Registration date
2023-08-31, 1402/06/09
Registrant information
Name
Mehdi Askari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3621 8926
Email address
mehdiaskari@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-29, 1402/06/07
Expected recruitment end date
2023-09-24, 1402/07/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation and comparison of side effects of two suturing methods/simple and horizontal mattress/after mandibular third molar surgery in patients who refer to surgery ward
Public title
suturing methods/simple and horizontal mattress/after mandibular third molar surgery
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Patient consent to participate in the study .
Absence of systemic diseases such as bone pathological conditions, hematological disorders, diabetes
Absence of pregnancy and breastfeeding 4.
The presence of a fully impacted tooth that requires surgery (wisdom teeth with mesiangular impact)
No smoking
Exclusion criteria:
Patients who need anesthesia and other interventions for wisdom tooth surgery
Patients who do not have wisdom teeth and can be treated with non-surgical methods
Age
From 18 years old to 25 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
Patients who meet the criteria for entering the study will be divided into two groups (28 patients with simple suturing, 28 patients with horizontal matrix suturing) by random allocation method using double randomized blocks. They are simplified from suture surgery and the second group is examined with the horizontal matrix method.
Blinding (investigator's opinion)
Double blinded
Blinding description
To increase the validity of the study, double-blinding method is used so that neither the patient nor the data analyst knows about the methods.
The patient does not know the method of suturing.
The data analyzer only analyzes the code and then the information is decoded.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Zand sums center
City
Shiraz
Province
Fars
Postal code
71348-14336
Approval date
2023-08-27, 1402/06/05
Ethics committee reference number
IR.SUMS.DENTAL.REC.1402.047
Health conditions studied
1
Description of health condition studied
Sutturing method after Mesioangular impacted wisdom tooth surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Determining the intensity of pain
Timepoint
The first day of surgery until the tenth day
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Complete recovery of the patient with pain: dehiscence and less swelling in the shortest possible time
Timepoint
The first day of surgery until the tenth day
Method of measurement
Visual Analogue Scale
Intervention groups
1
Description
In 1th intervention group , sulcular incision with ramus releasing is done.next aftet bone removal the wisdom tooth is removed.then gingiva is returned to previous position.next simple sutturing is done by silk 3_0 sutureabd 26 mm needle lenght.(made by SUPA company)
Category
Treatment - Surgery
2
Description
In 2th intervention group,sulcular incision with ramus releasing is done.next after bone removal the impacted wisdom tooth is removed.then gingive is returned to previous position.next horizontal mattress sutturing is done by 3-0 silk and 26 mm needle lenght (made by SUPA company )
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz dentistry university
Full name of responsible person
Farhad ghorbani
Street address
Ghasrodasht shiraz
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3629 1485
Email
Mehdiaskari@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farhad Ghorbani
Street address
Ghasrodasdht Ghom abab
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3629 1485
Email
Mehdiaskari@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Farhad
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Ghasrodasht
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
009836298564
Email
Mehdiaskari@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farhad Ghorbani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Ghasrodasht Ghomabad
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
009836291352
Email
Mehdiaskari@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mehdi askari
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Ghasrodasht Ghomabad
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3629 7852
Email
Mehdiaskari@sums.ac.ir
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