Determination of bone volume formed after bone grafting to an alveolar defect in control and fibrin glue treatment groups, 4 months after surgery
Design
The study population is individuals with a unilateral alveolar cleft.
According to the specific randomization method, the statistical population, which is a total of 20 people, is divided into two groups of intervention and control (each group has 10 patients).
Settings and conduct
This Single-blind clinical trial study will be performed on patients with unilateral alveolar clefts referred to Alzahra Hospital in Isfahan. The evaluators of the study results will be blind to the study groups. Patients in both groups are operated on according to standard surgical procedures for this type of disease, with the difference that in the intervention group, fibrin glue is also used. The results of fibrin glue are evaluated by a specialist using the cone-beam computed tomography (CBCT) method.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Presence of unilateral alveolar cleft, age 6 to 12 years
2. Conscious consent to participate in the study
Exclusion criteria:
1. Bilateral alveolar cleft
2. Presence of systemic diseases or pathological disorders
3. History of chemotherapy or radiotherapy
4. Patients with a history of unsuccessful alveolar graft
Intervention groups
The study population is divided into two groups of intervention and the control group. In the control group, normal alveolar bone grafting is performed and in the intervention group, in addition to surgery, fibrin glue is also used.
Main outcome variables
The volume of bone formed after graft
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210501051143N1
Registration date:2021-05-20, 1400/02/30
Registration timing:prospective
Last update:2021-05-20, 1400/02/30
Update count:0
Registration date
2021-05-20, 1400/02/30
Registrant information
Name
Mohammad hossein Manouchehri naeini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3785 1106
Email address
manouchehri@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-22, 1400/04/01
Expected recruitment end date
2021-08-23, 1400/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the success rate of alveolar bone grafts using fibrin glue
Public title
Investigation the effect of fibrin glue on alveolar graft
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with unilateral alveolar cleft
Ages 6 to 12 years
referred to Al-Zahra Hospital in Isfahan
Conscious consent to participate in the study
Exclusion criteria:
Bilateral alveolar cleft
Presence of systemic diseases or pathological disorders
History of chemotherapy or radiotherapy
Patients with a history of unsuccessful alveolar transplantation
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, patients were selected based on the inclusion and exclusion criteria of two-digit codes from 10 to 30, and randomization was performed based on the lottery method. Assignment codes were written on paper and placed inside an envelope. One of the researchers will pick up the written code without looking inside the envelope and will be assigned to the control group (A) or intervention group (B) alternatively. It should be noted that after removing each of the codes, in order to equalize the chances of all people, the read code will be placed again in the envelope, and in case of re-pick up an assigned code, it will be considered as an empty option.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients were randomly selected in such a way that they will be fully informed about the type of received treatment. Finally, the intervention effectiveness will be evaluated by the CBCT method compared to the control group. A specialist who is blind to the treatment procedures will assess the results, regardless of the control and intervention group, and report the results to each participant based on the assigned codes.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Isfahan University of Medical Sciences
Street address
Hezar Jerib St., Central Headquarters, Isfahan University of Medical Sciences and Health Services
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-03-17, 1399/12/27
Ethics committee reference number
IR.MUI.RESEARCH.REC.1400.002
Health conditions studied
1
Description of health condition studied
Unilateral alveolar cleft
ICD-10 code
K08.8
ICD-10 code description
Other specified disorders of teeth and supporting structures
Primary outcomes
1
Description
The volume of bone formed after transplantation
Timepoint
Before surgery and 4 months after bone graft
Method of measurement
Cone beam computed tomography method
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Includes ten patients with unilateral alveolar cleft who will undergo iliac crest bone graft surgery in the alveolar cleft area. After bone graft surgery, the nasal mucosa and palatal mucosa will be sutured.
Category
Treatment - Surgery
2
Description
Intervention group: Includes ten patients with unilateral alveolar cleft who will undergo iliac crest bone graft surgery in the alveolar cleft area. All interventions performed in this group will be completely similar to the control group, except for fibrin glue, which will be the only difference between the control group and the intervention group. After suturing the nasal mucosa and palatal mucosa, fibrin glue will be placed on the sutured part to prevent leaking bacteria into the transplant space.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Medical Center - Isfahan University of Medical Sciences
Full name of responsible person
Bijan Movahedian Attar
Street address
Soffe Blvd- Shahid Keshvari Highway -Alzahra Medical Center - Alzahra Hospital Isfahan-Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
Manouchehri@dnt.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjooy Javanmard
Street address
Building No. 4, Vice Chancellor for Research and Technology-Hezar Jerib St., Isfahan University of Medical Sciences and Health Services
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Isfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Bijan Movahedian Attar
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Oral and Maxillofacial Surgery
Street address
Department of Oral and Maxillofacial Surgery, School of Dentistry, Hezar Jerib St., University of Medical Sciences and Health Services
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
b_movahedian@dnt.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Bijan Movahedian Attar
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Oral and Maxillofacial Surgery, School of Dentistry
Street address
Department of Oral and Maxillofacial Surgery, School of Dentistry, Hezar Jerib St., University of Medical Sciences and Health Services
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
b_movahedian@dnt.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Bijan Movahedian Attar
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Oral and Maxillofacial Surgery
Street address
Department of Oral and Maxillofacial Surgery, School of Dentistry, Hezar Jerib St., University of Medical Sciences and Health Services
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
b_movahedian@dnt.mui.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
Yes - There is a plan to make this available
Title and more details about the data/document
Information about participants, including sex, age, the volume of alveolar cleft, and the amount of bone formed after the intervention in both control and intervention groups, can be published after the individuals have not been identified.
When the data will become available and for how long
The access period is immediately after publication the results
To whom data/document is available
Only people working in health care institutions and medical researchers
Under which criteria data/document could be used
Researchers involved in the field related to this study, including evaluating the CBCT method to investigate bone volume or the effectiveness of fibrin glue in bone grafting
From where data/document is obtainable
Isfahan University of Medical Sciences, Department of Oral and Maxillofacial Surgery, School of Dentistry, Dr. Bijan Movahedian Attar, b_movahedian@dnt.mui.ac.ir
What processes are involved for a request to access data/document
The applicant must provide the required documentation from a valid institution to receive the files