Evaluation of clinical parameters following application of routine rotary device in comparison with peizosurgery device for surgery of extraction of impacted third molar.
Design
Randomized clinical trial, double blinded, control group without placebo
Settings and conduct
In this study, which will be conducted in Zahedan Dental School, 30 patients with inclusion criteria and without exclusion criteria will be selected. one of studied methods randomly will choose for each side of patient mouth. Patients are recalled for specific follow-up sessions and will measure pain, swelling, and trismus in these sessions.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 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 degree of 2 and 3 and the maximum difference of 1 between the two sides in terms of the degree of difficulty and same trauma from surgery in both sides of surgery; patient with the ability to fill in a questionnaire and consent Exclusion criteria: patients with history of systemic diseases; surgery hardness above degree of 3
Intervention groups
Surgery in Intervention 1 group with the use of conventional rotary osteotomy instrument Surgery in Intervention 2 group with the use of new Piezosurgery osteotomy instrument
Main outcome variables
Pain; Swelling; Maximum mouth opening
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180515039664N2
Registration date:2020-05-11, 1399/02/22
Registration timing:retrospective
Last update:2020-05-11, 1399/02/22
Update count:0
Registration date
2020-05-11, 1399/02/22
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
2019-05-22, 1398/03/01
Expected recruitment end date
2019-06-22, 1398/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison and evaluation of pain, swelling and trismus of mandibular third molar surgery by conventional rotary device and piezoelectric surgery.
Public title
Comparison and evaluation of post-surgical outcome of mandibular third molar surgery by conventional rotary device and piezoelectric surgery.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Existance of impacted third lower molar in degree of A or B and Class I or II of impaction (Pell & Gregory classification)
Conscious consent to participate in the study
No decay
Absence of any systemic disease
No pregnancy or lactation
Exclusion criteria:
Any factor that prevents the patient from continuing to study
Age
From 18 years old to 50 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
Flip a coin were used to randomize samples.
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
2019-10-15, 1398/07/23
Ethics committee reference number
IR.ZAUMS.REC.1398.266
Health conditions studied
1
Description of health condition studied
Impacted teeth
ICD-10 code
K01.1
ICD-10 code description
Impacted teeth
Primary outcomes
1
Description
Pain
Timepoint
1st, 3rd, 7th, and 14th day after surgery
Method of measurement
VAS pain scale
2
Description
Trismus
Timepoint
1st, 3rd, 7th, and 14th day after surgery
Method of measurement
Clinical examination
3
Description
Trismus
Timepoint
1st, 3rd, 7th, and 14th day after surgery
Method of measurement
Clinical examinaion
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 surgical osteotomy in control group by NSK . Vmax surgical motor machine, made in Japan (35,000 rpm),to cool the surgical site during the operation, use 250 ml of sterile washing serum and then 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 surgical osteotomy in test group by Dmetec SurguryStar plus piezo machine made in South Korea,to cool the surgical site during the operation, use 250 ml of sterile washing serum and then 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
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
Mohammadali Fatehi MArj
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
m.ali.f.m1993@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
Mohammadali Fatehi MArj
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
m.ali.f.m1993@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