Evaluation of clinical parameters following application of typical suture technique in comparison with no suture for surgery of extraction of impacted third molar
Design
Randomized clinical trial, No blinded, control group without placebo
Settings and conduct
In this study, which will be conducted at Zahedan School of Dentistry, 30 patients will be selected for surgery with hardness grades 2 and 3 and the maximum difference between the two sides in terms of degree of hardness and classification 1 and in terms of trauma surgery on both sides in the same way. Randomly, for each side of the patient, one of the methods studied will be used following the third latent molar surgery. Patients will be called for follow-up at specific intervals, and the amount of pain, swelling, and trismus will be measured during these sessions.
Participants/Inclusion and exclusion criteria
Patients with no history of systemic disease who have a bilateral mandibular impacted third molar with the surgery hardness degree of maximum 7 and the classification of winter at mesioangular or vertical position and in terms of latency level A or B and class І or II in classification of Pell & Gregory.surgery with hardness grades 2 and 3 and the maximum difference between the two sides in terms of degree of hardness and classification 1 and in terms of trauma surgery on both sides in the same way.
Intervention groups
Test group: The third molar dental surgery is followed by no suture
Control group: Performing the third molar dental surgery and then using the usual suture technique
Main outcome variables
Pain; Swelling; Trismus
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180515039664N3
Registration date:2020-05-28, 1399/03/08
Registration timing:registered_while_recruiting
Last update:2020-05-28, 1399/03/08
Update count:0
Registration date
2020-05-28, 1399/03/08
Registrant information
Name
Sina Hakimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2272 9626
Email address
sinahakimi@irimc.org
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-21, 1399/03/01
Expected recruitment end date
2020-06-21, 1399/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of pain, swelling and trismus after mandibular impacted third molar tooth surgery with conventional sutured and sutureless technique
Public title
Investigating the effect of suture technique on treatment outcomes following mandibular third molar dental surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Existence of mandibular third molar with the degree of latency A and B and class I and II (based on Pell & Gregory classification)
Informed consent to participate in the study
surgery with hardness grades 2 and 3 and the maximum difference between the two sides in terms of degree of hardness and classification 1 and in terms of trauma surgery on both sides in the same way.
Exclusion criteria:
Existence of any systemic disease
Existence of decay
pregnancy or lactation
Take any coagulation medication
Age
From 16 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Flipping a coin will be used for randomization
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 Zahedan University of Medical Sciences
Street address
ZAUMS Main campus, Jenat Boulevard., Zahedan, Sistan and Baluchestan, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2020-05-03, 1399/02/14
Ethics committee reference number
IR.ZAUMS.REC.1399.044
Health conditions studied
1
Description of health condition studied
Impacted tooth
ICD-10 code
K01.1
ICD-10 code description
Impacted teeth
Primary outcomes
1
Description
Pain
Timepoint
1st, 3rd, 7th, and 15th day after surgery
Method of measurement
VAS pain scale
2
Description
swelling
Timepoint
1st, 3rd, 7th, and 15th day after surgery
Method of measurement
Clinical examination
3
Description
Trismus
Timepoint
1st, 3rd, 7th, and 15th day after surgery
Method of measurement
Clinical examination
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Injection of two lidocaine cartridges with the main anesthesia technique involves the use of an alveolar inferior nerve block (IANB) and Long buccally nerve block, then a triangular Fullthickness flap in the second and third molar teeth with a buccally inclination, followed by NSK surgical osteotomy. Vmax, made in Japan (35,000 rpm), will be followed by tooth extraction and silent washing with 40 ml of sterile serum, followed by suturing with a non-absorbent Silk floss of 3-0 by Simple loop suture technique
Category
Treatment - Surgery
2
Description
Intervention group: Injection of two lidocaine cartridges with the main anesthesia technique involves the use of an alveolar inferior nerve block (IANB) and Long buccally nerve block, then a triangular Fullthickness flap in the second and third molar teeth with a buccally inclination, followed by NSK surgical osteotomy. Vmax, made in Japan (35,000 rpm), will be followed by tooth extraction and silent washing with 40 ml of sterile serum, followed by the soft tissue will then be returned to its original position, but no sutures will be placed on it, and a small sterile gauze pad will be placed on it for at least 1 hour.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Zahedan university of medical sciences
Full name of responsible person
Sina Hakimi
Street address
College of Dentistry , Eastern Azadegan St. , Zahedan City
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3344 1814
Email
sinahakimi@irimc.org
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Nourmohammad Bakhshani
Street address
ZaUMS Main campus, Jenat Blvd., Zahedan, Sistan and Baluchestan, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3342 5765
Email
nmbakhsha@zdmv.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Roya Moradi Gohort
Position
Dentistry student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
College of Dentistry , Eastern Azadegan St. Zahedan city
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3329 5715
Email
roya.moradi.gohart1993@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Sina Hakimi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
East Azadegan St. - Kooye tir andazi - Zahedan College of Dentistry
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3329 5715
Email
sinahakimi@irimc.org
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Roya Moradi Gohort
Position
Dentistry Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
College of Dentistry , Eastern Azadegan St. Zahedan city
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3329 5715
Email
roya.moradi.gohart1993@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