Comparison of Probing Depth at Distal of Second Molar after Surgical Removal of Semi -Impacted and Eruption Wisdom Teeth in Lower Jaw by Two Suture Techniques
Comparison of probe depth in the distal region of the second molar after surgery of semi-impacted wisdom teeth
and mandibular growth with two suture methods
Design
The clinical trial has two groups of control and intervention. Which is performed in parallel and is double-blind. The sample size of 16 patients with bilateral mandibular wisdom teeth (32 wisdom teeth) requires surgery. Using a table of numbers A simple coincidence determines in which patient which side of the mandible is part of the control group and which side is part of the control group.
Settings and conduct
The study site is in the office of maxillofacial surgeon and dental clinic of Urmia University of Medical Sciences. The study is a double-blind study involving the patient and the person evaluating the results. The other side of the flap is stitched with a simple modified suture.
Participants/Inclusion and exclusion criteria
Inclusion criteria: bilateral semi-occlusion of the mandibular mandibular third molars or bilateral erupted third molars, over 16 and under 40 years of age. Exclusion criteria: pregnancy and lactation and intraoral infections such as acute periodontitis or apical periodontitis in last 6 months. Presence of systemic diseases (diabetes, hypertension, thalassemia and platelet deficiency) and the use of anticoagulants.
Intervention groups
People with bilateral tertiary molars in the mandible who have a simple modified suture on one side of the patient after wisdom tooth surgery, which is the same as our intervention group, and a simple suture on the opposite side of the same patient after surgery. To be part of the control group.
Main outcome variables
Periodontal pocket depth and clinical attachment loss in distal of second molar
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210107049961N1
Registration date:2021-02-02, 1399/11/14
Registration timing:registered_while_recruiting
Last update:2021-02-02, 1399/11/14
Update count:0
Registration date
2021-02-02, 1399/11/14
Registrant information
Name
sina ilkhani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3226 1497
Email address
dr.ilkhani.s@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-19, 1399/10/30
Expected recruitment end date
2021-07-05, 1400/04/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Probing Depth at Distal of Second Molar after Surgical Removal of Semi -Impacted and Eruption Wisdom Teeth in Lower Jaw by Two Suture Techniques
Public title
The effect of simple and modified sutures on complications of third molars
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Bilateral occlusion of the mandibular mandibular third molars bilateral erupted third molars
Age under 40 years old
No pregnancy or lactation
Exclusion criteria:
Pregnant women
Acute infection and intraoral lesions
Systemic diseases such as (diabetes, hypertension, etc.)
Age
From 16 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
16
More than 1 sample in each individual
Number of samples in each individual:
2
People who need bilateral third molars in the mandible
Randomization (investigator's opinion)
Randomized
Randomization description
In patients who need wisdom tooth surgery, we randomly suture a simple suture on one side and a modified suture on the other side in one patient. Syntax: from the sample of 16 patients, the first 8 are selected. Our surgical intervention is performed on the right wisdom tooth, and the surgical control group is on the left, and the remaining 8 intervention groups are on the left and the control group is on the right side of the patient.
Blinding (investigator's opinion)
Double blinded
Blinding description
The person who examines the results of different stitches in a person does not know the type of stitches on that side.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Urmia University of Medical Sciences
Complication of surgical and medical care, unspecified
2
Description of health condition studied
Gingival recession
ICD-10 code
K06.0
ICD-10 code description
Gingival recession
3
Description of health condition studied
Periodontal conditions
ICD-10 code
K05.5
ICD-10 code description
Other periodontal diseases
Primary outcomes
1
Description
Clinical attachment loss
Timepoint
Before surgery and 3 months later
Method of measurement
Michigan periodontal probe
2
Description
Probing depth
Timepoint
Before surgery and 3 months later
Method of measurement
Michigan periodontal probe
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: modified simple suture; insert the suture needle a little more mesially from the distal parasite line of the second molar from the buccal side, and also remove the needle more distal from the distal parasite line towards the lingual, and stretch the suture in the distal side of the second molar.
Category
Treatment - Surgery
2
Description
Control group: simple suture; the suture needle is inserted from the outer surface of the needle and exits from the opposite side of the riffle, and then re-enters the initial entry point of the needle and is tied.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Dentistry, Urmia University of Medical Sciences
Full name of responsible person
Dr. Sina Ilkhani
Street address
12 meters from Hadi, Alborz St.
City
Urmia
Province
West Azarbaijan
Postal code
5719736191
Phone
+98 44 3336 3590
Email
dr.ilkhani.s@gamail.com
2
Recruitment center
Name of recruitment center
Maxillofacial surgery office
Full name of responsible person
Dr. Sina Ilkhani
Street address
3rd floor, Iranmehr Building, Khan Babakhan
City
Urmia
Province
West Azarbaijan
Postal code
5716663139
Phone
+98 44 3226 1497
Email
dr.ilkhani.s@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr Iraj Mohebbi
Street address
Urmia University of Medical Sciences, Emergency Alley, Resalat Boulevard
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Email
dr.mohebbi.iraj@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Sina Ilkhani
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Maxillofacial surgery
Street address
Urmia University of Medical Sciences, Orjhans Alley, Resalat Boulevard
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Email
dr.ilkhani.s@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Sina Ilkhani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Maxillofacial surgery
Street address
Urmia University of Medical Sciences, Orjhans Alley, Resalat Boulevard
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Email
dr.ilkhani.s@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Sina Ilkhani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Maxillofacial surgery
Street address
Urmia University of Medical Sciences, Orjhans Alley, Resalat Boulevard
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Email
dr.ilkhani.s@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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available