Comparative evaluation of immediate and delayed addition of nasal stent to nasoalveolar molding plate on nostrils shape and cleft width among patients with unilateral cleft lip and palate
The aim of present study is to compare immediate and delayed addition of nasal stent to nasoalveolar molding plate on nostrils shape and cleft width among patients with unilateral cleft lip and palate
Design
Randomized, superiority, parallel group single blind clinical trial
Settings and conduct
Twenty infants with unilateral cleft lip and palate are included in the study. First, all patients are referred to the proficient radiology scanner for facial scans. In the control group, insertion of nasal stent into the nasoalveolar plaque is performed when the width of the cleft is 5 mm. In the intervention group, insertion of nasal stent into the nasoalveolar plaque in the initial phase of the treatment occurs when the cleft width is greater than 5 mm. The treatment continues for 2 months after insertion of the stent in each group, and ultimately the patients will be referred to the radiology clinic for a final scan of the face with the proface software.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age is under one month; Alveolar width greater than 6 mm; Parent cooperation; Informed consent.
Non Inclusion criteria: syndromic patient
Intervention groups
In the intervention group, insertion of nasal stent into the nasoalveolar plaque in the initial phase of the treatment occurs when the cleft width is greater than 5 mm.
In the control group, insertion of nasal stent into the nasoalveolar plaque is performed when the width of the cleft width is 5 mm.
Main outcome variables
Width of the gap; columellar deviation angle; nostril width; nostril height; inter comisural distance; soft tissue cleft width; the nasal area on the left and right side of the line from Nasion to Subnasal
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180828040897N1
Registration date:2018-12-21, 1397/09/30
Registration timing:registered_while_recruiting
Last update:2018-12-21, 1397/09/30
Update count:0
Registration date
2018-12-21, 1397/09/30
Registrant information
Name
Abdollah Jamalinasab
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 76 3334 8313
Email address
jamalinasaba961@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-22, 1397/09/01
Expected recruitment end date
2019-11-22, 1398/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative evaluation of immediate and delayed addition of nasal stent to nasoalveolar molding plate on nostrils shape and cleft width among patients with unilateral cleft lip and palate
Public title
The effect of immediate and delayed addition of nasal stent to nasoalveolar molding plate among patients with unilateral cleft lip and palate
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age under one month
Alveolar width greater than 6 mm
Parent's cooperation
Informed consent
Exclusion criteria:
Syndromic disease (patients)
Age
From 1 day old to 30 days old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization based on blocking method
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients are unaware to what intervention or control group they will be assigned.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the Mashhad University of Medical Sciences
Street address
Mashhad University of Medical Sciences, Vakil Abad Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Approval date
2018-10-28, 1397/08/06
Ethics committee reference number
IR.MUMS.DENTISTRY.REC.1397.072
Health conditions studied
1
Description of health condition studied
Cleft palate
ICD-10 code
Q35
ICD-10 code description
Cleft palate
2
Description of health condition studied
cleft lip
ICD-10 code
Q36
ICD-10 code description
Cleft lip
Primary outcomes
1
Description
columellar deviation angle: The intercalary angle that passes from the Clomarlar with the horizontal line in the subjective mental view of the radiograph
Timepoint
The beginning and the end of the treatment
Method of measurement
Using proface software (picture derived from software)
2
Description
nostril width: The greatest distance between the clommler and the alar of nose in each side
Timepoint
The beginning and the end of the treatment
Method of measurement
Using proface software (picture derived from software)
3
Description
nostril hight: the distance between the anteriormost point of the nasal cavity and the posterior part of the nose
Timepoint
The beginning and the end of the treatment
Method of measurement
Using proface software (picture derived from software)
4
Description
inter comisural distance: the distance between the two corners of the lip
Timepoint
The beginning and the end of the treatment
Method of measurement
Using proface software (picture derived from software)
5
Description
soft tissue cleft width: Maximum distance from the two edges of the cleft lip
Timepoint
The beginning and the end of the treatment
Method of measurement
Using proface software (picture derived from software)
6
Description
The nasal area is on the left and right side of the line from Nasion to Subnasal.
Timepoint
The beginning and the end of the treatment
Method of measurement
Using proface software (picture derived from software)
7
Description
clinical width of the gap
Timepoint
Weekly until the end of the study
Method of measurement
Use a caliper with a precision of 1 mm for
8
Description
width of the gap
Timepoint
Monthly until the end of the study
Method of measurement
Based on models scanned with Cone beam computed tomography
Secondary outcomes
empty
Intervention groups
1
Description
Control group: 10 patients with unilateral cleft of lip and palate are included. First, all patients are referred to the proficient radiology scanner for facial scans, using proface software. In this group, insertion of nasal stent into the nasoalveolar plaque is performed when the width of the cleft is 5 mm. Each week the plaques are adjusted with selective grinding and adding of elastic materials and the gap is measured monthly. The treatment continues for 2 months after insertion of the stent in each group, and ultimately the patients will be referred to the radiology clinic for a final scan of the face with the proface software.
Category
Treatment - Devices
2
Description
Intervention group: 10 patients with unilateral cleft of lip and palate are included. First, all infants are referred to the proficient radiology scanner for facial scans, using proface software. In this group, insertion of nasal stent into the nasoalveolar plaque in the initial phase of the treatment occurs when the cleft width is greater than 5 mm. Each week the plaques are adjusted with selective grinding and adding of elastic materials and the gap is measured monthly. After 2 months of insertion of the stent, the infants will be referred to the radiology clinic for a final scan of the face with the proface software.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Akbar Hospital
Full name of responsible person
Ali Khakshour
Street address
Akbar Hospital. Fakori Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3871 3803
Email
khakshoura@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Mashhad University of Medical Sciences, in front of Daneshgah 18 avenue, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3841 2081
Email
tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Arezo Jahanbin
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Mashhad Dental School, Vakilabad Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3883 2301
Email
abdollahjamalinasab@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Arezo Jahanbin
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Mashhad Dental School, Vakilabad Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3883 2301
Email
abdollahjamalinasab@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Abdollah Jamalinasab
Position
Resident of orthodontics
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Boostan dormitory ; Shahid Bahonar Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948988
Phone
+98 76 3334 8313
Fax
Email
jamalinasaba961@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
A portion of the data, such as data on the main outcome or like that can be shared.
When the data will become available and for how long
Starting the access period 6 months after printing results
To whom data/document is available
own data will only be available to researchers working in academic and academic institutions
Under which criteria data/document could be used
You have to completely control the data and get the credentials from the author.