Evaluation of clinical success of low intensity ultrasound application in comparison with conventional autogenous bone graft in the reconstruction of alveolar cleft defects in patients with clefts of hard palate and unilateral cleft of lips
Investigating the application of low intensity ultrasound in comparison with autogenous bone in the reconstruction of alveolar cleft defects
Design
Clinical trial with control group, with parallel groups, single blind, non-randomized, with a sample size of 14 patients
Settings and conduct
14 patients will be selected by using non-random sampling and from two clinics of Mashhad Dental School. Of the 14 patients, alone autologous bone graft will be done for 7 patients and others will be subjected to the pulsed ultrasound after transplantation for one minute at 1MHz frequency and 500 mW intensity for 6 weeks. In order to measure the gap size, occlusal and peri apical radiography will be used, and the two groups will be identical in this regard. Postoperative immediate CBCTs will be provided to assess the shape and appearance of graft and affected teeth. One month after surgery, patients will be examined for the progression of graft repair and growth patterns of affected teeth. At the end, the radiographic evaluation will be performed by an independent evaluator who has not participated in the preoperative orthodontic treatment for any patient in the study.
Participants/Inclusion and exclusion criteria
Patients with palate and lips cleft that their palatal bone has been expanded and they have been prepared for alveolar graft at age range of 9 to 13 years old and have their parent's informed consent
Intervention groups
In the intervention group, from day after transplantation, low-intensity ultrasound pulses will be applied for 1 minute at a frequency of 1 MHz and 500 mW in intensity for a period of 6 weeks. In the control group, the normal procedure will be performed with the autologous bone graft of the illiac region of the patient.
Main outcome variables
Progression of the graft repair and the pattern of affected adjacent tooth
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181022041411N1
Registration date:2018-12-07, 1397/09/16
Registration timing:registered_while_recruiting
Last update:2018-12-07, 1397/09/16
Update count:0
Registration date
2018-12-07, 1397/09/16
Registrant information
Name
Amirreza Mashreghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3768 3564
Email address
mashreghia951@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2019-09-23, 1398/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of clinical success of low intensity ultrasound application in comparison with conventional autogenous bone graft in the reconstruction of alveolar cleft defects in patients with clefts of hard palate and unilateral cleft of lips
Public title
Evaluation of success of low intensity ultrasound application in the reconstruction of alveolar bone
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with unilateral palate and lips cleft
Patients who their palatal bone has been expanded
Parental informed consent
Exclusion criteria:
Patients with bilateral palate and lips clefts
Patients with other syndromes
Patients who can not be surgically treated because of medical problems
Age
From 9 years old to 13 years old
Gender
Both
Phase
2-3
Groups that have been masked
Data analyser
Sample size
Target sample size:
14
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The analyst will be unaware of the intervention and control groups because the data will be presented as anonymous code to the statistician.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Faculty of Dentistry-Mashhad University of Medical Sciences
Street address
Mashhad dental school, Vakilabad Boulevard
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Approval date
2018-05-16, 1397/02/26
Ethics committee reference number
IR.MUMS.DENTISTRY.REC.1397.012
Health conditions studied
1
Description of health condition studied
Cleft hard palate with unilateral cleft lip
ICD-10 code
Q37.1
ICD-10 code description
Cleft hard palate with unilateral cleft lip
Primary outcomes
1
Description
The progression of the graft repair and the pattern of affected adjacent tooth
Timepoint
1, 3 and 6 months after bone graft surgery
Method of measurement
Radiographic images of CBCT, occlusal and periapical
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: From the day after the transplantation, patients will be subjected to pulsed ultrasound at low intensity for 1 minute at a frequency of 1 MHz and an intensity of 500 mW for 6 weeks.
Category
Treatment - Other
2
Description
Control group: The normal procedure will be performed with the autologous bone graft of the illiac region of the patient
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of palatal and lip cleft of Mashhad dental school
Full name of responsible person
Dr. Arezoo Jahanbin
Street address
Mashhad dental school, Vakilabad boulvard
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3882 9501
Email
mail@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Arezoo Jahanbin
Street address
Mashhad dental school, Vakilabad boulvard
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3882 9501
Email
mail@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
30
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
2
Sponsor
Name of organization / entity
Deputy of Research of Mashhad University of Medical Sciences
Full name of responsible person
Hossein Bagheri
Street address
Mashhad dental school, Vakilabad boulvard.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3882 9501
Email
mail@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research of Mashhad University of Medical Sciences
Proportion provided by this source
30
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
Amirreza Mashreghi
Position
Assistant of orthodontics
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Mashhad dental school, Vakilabad boulvard
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3882 9501
Email
mashreghia891@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Arezoo Jahanbin
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Mashhad dental school, Vakilabad Boulvard
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3882 9501
Email
jahanbina@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Amirreza Mashreghi
Position
Resident of orthodontics
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Mashhad dental school, Vakilabad boulvard
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3882 9501
Email
mashreghia891@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available