Comparison of pain perception and tissue repair after frenectomy with surgical blade and 445 nm and 970 nm diode laser
Design
Clinical trial with a control group with parallel group, with blinding of only outcome assessment and data collection, randomized with Random Allocation Software using 29 block on 174 patients
Settings and conduct
The study will be carried on in the dental clinic of Mazandaran University of Medical Sciences. 174 participants will be allocated to three groups using blocks of 6 with Random Allocation Software. Assessments will be performed by a blinded individual immediately after surgery, 7, 14 and 28 days after surgery. Data collection will also be performed by a blinded researcher and the data will be concealed and sent to the statistician for analysis. Results will be provided to the blind writer of the draft, who will in turn compose the draft and share it with all the researchers to edit and provide the final manuscript.
Participants/Inclusion and exclusion criteria
Need of frenectomy surgery in orthodontic treatment, not undergoing speech therapy, periodontal therapy and prosthetic treatment in anterior maxilla
Intervention groups
Intervention group 1: 445 nm diode laser
Intervention group 2: 970 nm diode laser
Control group: scalpel
Main outcome variables
Post-operative pain and tissue healing
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220630055326N1
Registration date:2022-10-29, 1401/08/07
Registration timing:prospective
Last update:2022-10-29, 1401/08/07
Update count:0
Registration date
2022-10-29, 1401/08/07
Registrant information
Name
Aryousha Moallemsavasari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3320 7729
Email address
a.moallem@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-22, 1401/09/01
Expected recruitment end date
2022-12-22, 1401/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of pain perception and tissue repair after frenectomy with surgical blade and 445 nm and 970 nm diode laser: a clinical trial study
Public title
Comparison of 445 nm and 970 nm diode lasers and surgical blade in frenectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Need for orthodontic treatment
Need for labial frenectomy
Participants will be divided into 29 blocks of 6 and then allocated to one of the three groups of the study using Random Allocation Software.
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 Mazandaran University of Medical Sciences
Street address
Deputy of Research and Technology of Mazandaran University of Medical Sciences, Moallem Sq.
City
Sari
Province
Mazandaran
Postal code
4815733971
Approval date
2022-10-08, 1401/07/16
Ethics committee reference number
IR.MAZUMS.REC.1401.338
Health conditions studied
1
Description of health condition studied
Dental diastema and high labial frenum
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Postoperative pain
Timepoint
Immediately after the surgery, 7 days, 14 days and 28 days after the surgery
Method of measurement
Visual Analogue Scale questionnaire
2
Description
Postoperative wound healing
Timepoint
Immediately after the surgery, 7 days, 14 days and 28 days after the surgery
Method of measurement
Clinical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: 445 nm diode laser
Category
Treatment - Surgery
2
Description
Intervention group 2: 970 nm diode laser
Category
Treatment - Surgery
3
Description
Control group: scalpel
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Baghban Dental Clinic
Full name of responsible person
Abbas Mesgarani
Street address
Baghban Dental Clinic, Khazar Blvd.
City
Sari
Province
Mazandaran
Postal code
4816895471
Phone
+98 11 3324 4894
Email
dentistry@mazums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Pedram Ebrahimnejad
Street address
Deputy of Research and Technology of Mazandaran University of Medical Sciences, Moallem Sq.
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3325 7230
Fax
+98 11 3326 1244
Email
pajoheshi@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Farhad Sobouti
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Baghban Dental Clinic, Khazar Blvd.
City
Sari
Province
Mazandaran
Postal code
4816895471
Phone
+98 11 3324 4894
Email
farhad_sobouti@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Sepideh Dadgar
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Baghban Dental Clinic, Khazar Blvd.
City
Sari
Province
Mazandaran
Postal code
4816895471
Phone
+98 11 3324 4894
Email
dadgar_sepideh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
َAryousha Moallem Savasari
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No. 4, Gol-e Sorkh Bldg., 13th Alley, Mahdiye St.
City
Sari
Province
Mazandaran
Postal code
4818897388
Phone
+98 11 3320 7728
Email
aaryoosha@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Title and more details about the data/document
Information about the main outcomes of the study and their relationship with the variables of the study will be published after anonymizing the data.
When the data will become available and for how long
The access period will start 3 months after the results are published.
To whom data/document is available
Researchers working in universities, institutes and scientific centers and people working in related industries can apply to receive the data.
Under which criteria data/document could be used
The use of data for the purpose of independent analysis is unimpeded, but any activity leading to the publication using the data is subject to obtaining explicit permission.
From where data/document is obtainable
In order to receive data, it is necessary to send a request to the first author of the article, Aryousha Moallem Suvasri, via the email address a.moallem@mazums.ac.ir or aaryoosha@gmail.com. If needed, call +989112561042.
What processes are involved for a request to access data/document
The request received via e-mail will be read and considered within two working days, and negotiations will begin to coordinate and ensure that the applicant meets the conditions by the same time. It is expected to take no more than seven working days to send the documents to the applicant.