The aim of this study was to evaluate the efficacy of CO2
laser for vestibuloplasty in the anterior region of the maxilla
in cleft patients and also increase in the length of the upper lip in these patients
Design
This clinical trial study, cleft lip and palate patients with shallow vestibule depth undergo CO2 laser surgery and the depth of the vestibule are measured before surgery, one week and four months after surgery.This study did not have control group
Settings and conduct
Cleft lip and palate patients presenting to the Department of Orthodontics of Yazd University of Medical sciences who had vestibular depth loss
in the anterior maxilla are included in the study.The surgery is performed using CO2 laser for increasing vestibule depth, then measure the depth of the vestibule and the length of the lips in three steps in these patients by the digital caliper.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Cleft and lip patients who had vestibular depth loss
in the anterior maxilla following primary cleft surgery
Exclusion criteria; Patients who had already underwent
secondary surgery for vestibuloplasty and subjects with certain
systemic problems
Intervention groups
15 patients undergo CO2 laser surgery to increase the depth of the vestibule in the anterior maxilla area.
Main outcome variables
vestibule depth, upper lip length
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180314039089N1
Registration date:2018-04-13, 1397/01/24
Registration timing:prospective
Last update:2018-04-13, 1397/01/24
Update count:0
Registration date
2018-04-13, 1397/01/24
Registrant information
Name
soghra yassaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3621 2222
Email address
s.yassaei@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-19, 1397/01/30
Expected recruitment end date
2018-06-20, 1397/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of carbon dioxide laser on increasing vestibular depth in cleft lip and palate patients
Public title
Effect of CO2 laser on vestibule depth
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Cleft lip and palate patients
presenting to the Department of Orthodontics of Yazd University of Medical sciences
have vestibular depth lossin the anterior maxilla
following primary cleft surgery
Exclusion criteria:
Patients who had already underwent secondary surgery for vestibuloplasty
subjects with certain systemic problems
heart disease (pacemaker)
pregnancy
epileptic seizures
thyroid gland disease
malignancies
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
15
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
Ethics committee of Shahid Sadoughi Yazd university of medical Science
Street address
Central organization Shahid Sadoughi Yazd University of Medical Sciences, Shahid Bahonar Square, Yazd
City
Yazd
Province
Yazd
Postal code
8916978477
Approval date
2015-04-13, 1394/01/24
Ethics committee reference number
IR.SSU.REC.1394.17438
Health conditions studied
1
Description of health condition studied
vestibule deformity
ICD-10 code
H81
ICD-10 code description
Disorders of vestibular function
Primary outcomes
1
Description
vestibular depth
Timepoint
before surgery, 1 week following surgery, 4 months following surgery
Method of measurement
digital caliper
2
Description
upper lip length
Timepoint
before surgery, 1 week following surgery, 4 months following surgery
Method of measurement
digital caliper
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group, CO2 laser with wavelength 10.600 nm, with output power of 5 W and continuous mode used for surgery
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry, Shahid Sadoughi Yazd University of Medical Sciences