Evaluation of lip movement in patients with unilateral cleft lip, before and after vestibuloplasty by Co2 laser in patients referred to the School of Dentistry
Design
control group includes patients with unilateral or bilateral cleft lip before vestibuloplasty and the intervention group includes the same patients after vestibuloplasty.The sample size includes 20 people. This study does not have a second phase. The patients are people with cleft lip and palate who refer to the orthodontic department of Yazd Dental School and we have no involvement in what economic, social, etc. group these people belong to.There is no possibility of blindness.
Settings and conduct
In this study, which is a clinical trial before and after, 20 people with unilateral or bilateral cleft lip are studied. Samples will be selected from patients with cleft lip, referred to Yazd Dental School and according to the inclusion and exclusion criteria.
Before the study, the method and purpose of the study are explained to the patient and written consent is obtained from the samples, patients are assured that all information is confidential, then the samples are entered into the study and how the lips move electromyographically. Will be checked.The patient's satisfaction with the results of the surgery is also measured by a questionnaire.
Participants/Inclusion and exclusion criteria
1- Patients with unilateral cleft lip referred to Yazd Dental School orthodontic department at the time of research
2- Age over 12 years
Patients should not have a syndromic cleft.
4. Filling in the informed consent of the patient to enter the study
Intervention groups
The intervention group is the same as the control group, but after vestibuloplasty.
Main outcome variables
How to change lip movement after vestibuloplasty by co2 laser
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210321050751N1
Registration date:2021-05-15, 1400/02/25
Registration timing:prospective
Last update:2021-05-15, 1400/02/25
Update count:0
Registration date
2021-05-15, 1400/02/25
Registrant information
Name
Soghra Yassaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3625 6975
Email address
syassaei@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-22, 1400/03/01
Expected recruitment end date
2021-06-21, 1400/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of lip movement in patients with unilateral cleft lip, before and after vestibuloplasty by Co2 laser
Public title
Evaluation of lip movement in patients with unilateral cleft lip, before and after vestibuloplasty by Co2 laser
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
1- Patients with unilateral cleft lip referred to Yazd Dental School orthodontic department at the time of research
Age over 12 years
Patients should not have a syndromic cleft
Filling in the informed consent of the patient to enter the study
Exclusion criteria:
Any illness and trauma that occurs in the samples after the start of the study and affects the movement of the lips.
Reluctance to participate in the study
Age
From 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
More than 1 sample in each individual
Number of samples in each individual:
2
Sample: Orbicularis oris muscle in the patient before and after the intervention
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Yazd shahid sadoughi university of medical science
Street address
Yazd. Dahe fajr Boulevard. Imam Reza Street.shahid sadoughi university of medical science
City
yazd
Province
Yazd
Postal code
8914881167
Approval date
2021-02-21, 1399/12/03
Ethics committee reference number
IR.SSU.REC.1399.267
Health conditions studied
1
Description of health condition studied
Lip movement in patients with cleft lip
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Changes in lip muscle contraction and movement
Timepoint
Twenty days after vestibuloplasty
Method of measurement
Using electromyography
2
Description
Patient satisfaction with vestibuloplasty results
Timepoint
Twenty days after vestibuloplasty
Method of measurement
Using a questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients with unilateral or bilateral cleft lip and palate in which vestibuloplasty is performed as an intervention. Co2 laser is used to perform vestibuloplasty. After surgery, there is no need for sutures, the patient experiences little discomfort and There is no bleeding. This intervention will be performed only once in each patient.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Orthodontics, Shahid Sadoughi School of Dentistry, Yazd
Full name of responsible person
Elahe Salarpour
Street address
Yazd. Fajr Decade Boulevard. Imam Reza St.. Shahid Sadoughi Dental School of Yazd
City
yazd
Province
Yazd
Postal code
8914881167
Phone
+98 35 3625 5813
Email
samat@ssu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
maseud mirzaei
Street address
Department of Orthodontics, Shahid Sadoughi School of Dentistry, Yazd
City
yazd
Province
Yazd
Postal code
8914881167
Phone
+98 35 3726 3733
Email
mmirzaei@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
elahe salarpour
Position
orthodontics resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Department of Orthodontics, Shahid Sadoughi School of Dentistry, Yazd
City
yazd
Province
Yazd
Postal code
8914881167
Phone
+98 34 3428 4157
Email
dr.elahe.salarpour@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
elahe salarpour
Position
orthodontics resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Department of Orthodontics, Shahid Sadoughi School of Dentistry, Yazd
City
yazd
Province
Yazd
Postal code
8914881167
Phone
+98 34 3428 4157
Email
dr.elahe.salarpour@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
elahe salarpour
Position
orthodontic resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
یزد .بلوار دهه فجر.خیابان امام رضا.دانشکده علوم پزشکی شهید صدوقی یزد.
City
yazd
Province
Yazd
Postal code
8914881167
Phone
+98 34 3428 4157
Email
dr.elahe.salarpour@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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
After unidentifying ,it is possible to share all variables of patients.
When the data will become available and for how long
After unidentifying ,it is possible to share all variables of patients.
To whom data/document is available
Researchers working in academic and scientific institutions and valid scientific research
Under which criteria data/document could be used
In order to use the documents of this study for other studies and researches to apply the results and a step forward for the use of lasers in patients with cleft lip and palate
What processes are involved for a request to access data/document
The applicant can send his request to the above- mentioned email address his/her introduction and the reason for the request and receive the information as soon as possible (finally within 7-10 days)