Objective: To compare the effect of rhBMP-2 injection and non-injection on palatal expansion in cleft lip and palate patients. Design: A single-blind randomized clinical trial. Study population: Cleft lip and palate patients who need alveolar bone grafting referring to Dental Clinic of Mashhad Faculty of Dentistry. Inclusion criteria: cleft lip and palate patients; aged over 11 years showing after puberty stage (before CS3) based on cervical vertebral stadium (CVS). Exclusion criteria: Having certain systemic diseases; unwillingness to continue the study. Sample size: 16 cases. Study intervention: The control group underwent standard alveolar bone grafting, and the intervention group receiving standard alveolar bone grafting with rhBMP-2 injection. Study outcome: evaluation and comparison of the width between canines, width between the first premolars, width between the first permanent molars, as well as volume and density of alveolar bone defects with cone beam computed tomography (CBCT) in the intervention and control groups before, as well as immediately and three months after the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017051533974N1
Registration date:2017-06-25, 1396/04/04
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-06-25, 1396/04/04
Registrant information
Name
Sahar Irani
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38823255
Email address
iraniss921@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2017-07-23, 1396/05/01
Expected recruitment end date
2018-07-23, 1397/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial to compare the effect of rhBMP-2 injection and non-injection on palatal expansion in cleft lip and palate patients
Public title
The effectiveness of rhBMP-2 injected on palatal expansion.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: cleft lip and palate patients; aged over 11 years showing after puberty stage (before CS3) based on cervical vertebral stadium (CVS).
Exclusion criteria: Having certain systemic diseases; unwillingness to continue the study
Age
From 11 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
16
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Postal code
Approval date
2015-10-14, 1394/07/22
Ethics committee reference number
IR.mums.sd.REC.1394.26
Health conditions studied
1
Description of health condition studied
Cleft lip and palate patients
ICD-10 code
Q37
ICD-10 code description
Cleft palate with cleft lip
Primary outcomes
1
Description
Width between canines
Timepoint
Before, as well as immediately and 3 months after intervention
Method of measurement
Cone beam computed tomography (CBCT)
2
Description
First pre-cooled
Timepoint
Before, as well as immediately and 3 months after intervention
Method of measurement
Cone beam computed tomography (CBCT)
3
Description
Volume and density of alveolar bone defects
Timepoint
Before, as well as immediately and 3 months after intervention
Method of measurement
Cone beam computed tomography (CBCT)
4
Description
First permanent molar
Timepoint
Before, as well as immediately and 3 months after intervention
Method of measurement
Cone beam computed tomography (CBCT)
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Who is revising standard alveolar bone grafting, the effectiveness of skeletal and dental are examining 4 months after intervention before, as well as immediately and 3 months after intervention.
Category
Treatment - Surgery
2
Description
Interventional group: Who is revising standard alveolar bone grafting with rhBMP-2 injection, the effectiveness of skeletal and dental are examining 4 months after intervention before, as well as immediately and 3 months after intervention.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad Faculty of Dentistry Dental Clinic
Full name of responsible person
Sahar Irani
Street address
Dental Clinic of Mashhad Faculty of Dentistry, Opposite Mellat Park, Vakilabad Blvd
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
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
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad Faculty of Dentistry
Full name of responsible person
Sahar Irani
Position
Orthodontic Residents
Other areas of specialty/work
Street address
Opposite Mellat Park, Vakilabad Blvd Mashhad
City
Mashhad
Postal code
Phone
+98 51 3806 7224
Fax
Email
Iraniss921@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad Faculty of Dentistry
Full name of responsible person
Sahar Irani
Position
Orthodontic Residents
Other areas of specialty/work
Street address
Opposite Mellat Park, Vakilabad Blvd Mashhad
City
Mashhad
Postal code
Phone
+98 51 3806 7224
Fax
Email
Iraniss921@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad Faculty of Dentistry
Full name of responsible person
Sahar Irani
Position
Orthodontic Residents
Other areas of specialty/work
Street address
Opposite Mellat Park, Vakilabad Blvd Mashhad
City
Mashhad
Postal code
Phone
+98 51 3806 7224
Fax
Email
Iraniss921@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)