Determination of the percentage of canine eruption after corticocancellous iliac graft
Design
Non randomized split mouth clinical trial of 41 patients with congenital palatal cleft
Settings and conduct
In this study, the reconstruction of the alveolar gap in the congenital cleft palate patients referred to Mashhad dental school is done. corticocancellous iliac graft in wedge shape is used to reconstruct the alveolar cleft. The other side of maxilla who has no gap is considered as control group. Clinical and radiographic examinations are performed before and after 14 days, 3 and 12 months after surgery at Mashhad dental school. The canine angel is measured as an angle between the longitudinal axis of the crown tip to the tip of the root and the plan drawn from two condyles in the panoramic radiograph. The amount of bone formed is evaluated in PA radiography by Bergland method.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
The full one-sided cleft lip and palate without any other craniofacial anomalies
orthopedic jaw expansion was performed for childeren, and there is space for canine tooth eruption.
At the age of second mixed dentition with unerupted canine tooth bud with root formation rate of 1/3 to 2/3.
exclusion criteria:
Infection and dehiscence of graft recipient's site and patients who do not come for follow up.
Intervention groups
Children with congenital alveolar clefts.
Main outcome variables
Eruption height of canine teeth; bone volume that formed in the cleft area
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190126042491N1
Registration date:2020-07-11, 1399/04/21
Registration timing:registered_while_recruiting
Last update:2020-07-11, 1399/04/21
Update count:0
Registration date
2020-07-11, 1399/04/21
Registrant information
Name
Amin Rahpeyma
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3882 9501
Email address
rahpeymaa@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-23, 1398/02/03
Expected recruitment end date
2020-08-24, 1399/06/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the effect of corticocancellous iliac graft on maxillary canine eruption
Public title
Investigation of the effect of pelvic graft for cleft palate on canine tooth eruption
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The complete one-sided cleft lip and palate without any other craniofacial anomalies.
Children have orthopedic expansion before surgery, and there is space for canine tooth eruption
In children with secondary mixed dentition that have unerupted canine bud with root formation rate of 1:3 to 2:3
Exclusion criteria:
Infection
dehiscence
Patients Do not refer for follow-up
Age
From 8 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
41
Randomization (investigator's opinion)
N/A
Randomization description
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 Mashhad University of Medical Sciences
Street address
Vakilabad Blvd, Ferdowsy University, Dental college
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Approval date
2019-03-10, 1397/12/19
Ethics committee reference number
IR.MUMS.DENTISTRY.REC.1397.116
Health conditions studied
1
Description of health condition studied
Alveolar cleft of maxilla
ICD-10 code
K08.8
ICD-10 code description
Other specified disorders of teeth and supporting structures
Primary outcomes
1
Description
Canine eruption
Timepoint
3 and 12 months after graft surgery
Method of measurement
Panoramic Radiography, expose in mouth
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Alveolar cleft side of 41 patients undergoing corticocancellous anterior iliac crest graft surgery with the wedge method.
Category
Treatment - Surgery
2
Description
Control group: Non-cleft side of 41 patients that no extra work is done.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem hospital of Mashhad University of medical science
Full name of responsible person
Dr Amin Rahpeyma
Street address
department of oral and maxillofacial surgery , Dental school, Mashhad , Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3882 9501
Fax
+98 51 3882 9500
Email
rahpeymaa@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,Daneshgah St. Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3882 3255
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
Adel Sharifi Rayeni
Position
Resident of Oral and Maxillofacial surgery
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3806 7101
Email
Sharifi.r.adel@gmail.con
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Amin
Position
Associated professor of oral and maxillofacial surgery
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dental Research Center of Mashhad University of Medical Sciences ,Vakilabad Blvd, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
91735-984
Phone
+98 51 3882 9501
Email
rahpeymaa@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Saeede
Position
Associated professor of oral and maxillofacial pathology
Latest degree
Specialist
Other areas of specialty/work
Pathology
Street address
Dental Research Center of Mashhad University of Medical Sciences ,Vakilabad Blvd, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
91735-984
Phone
+98 51 3882 9501
Email
khajehahmadis@mums.ac.ir
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
No - There is not a plan to make this available
Title and more details about the data/document
After completing the study, the paper is sent for publication in scientific journals.
When the data will become available and for how long
About two months after the completion of the study, the paper is sent for publication and will be available in the journal.
To whom data/document is available
For those who have access to scientific journals, they will be available.
Under which criteria data/document could be used
It will be available to anyone interested.
From where data/document is obtainable
From the journal where the article will be printed will be accessible.
What processes are involved for a request to access data/document
Interested persons can recieve study information through email after publishing the article.