The success evaluation of bone grafts treatment in patients with unilateral alveolar cleft using mixture of allograft and symphisis bone compared to iliac bone graft alone
Determining and Comparing the Average Percentage of Bone Formed in the Alveolar Fissure in Different Ways
Design
Clinical Trial with Control Group, with Parallel Groups, Double-Blind, Randomized. Patients list randomized by computer program.
Settings and conduct
Iliac crest bone graft use commonly as donor site in alveolar cleft patients operation.in this study . We will compare iliac bone graft versus chin symphisis bone combine with allograft in operations results success .
This clinical study will perform in Alzahra Hospital ,Isfahan. patients with unilateral alveolar cleft were randomly divided into two groups:
Group A: Patients who will be treated with combination of chin symphysis and allograft
Group B: Patients who will be treated with iliac bone graft alone
Before and one year after treatment CBCT will be used to measure the volume of new bone regeneration .
Patients not know the location of donor site before the operation, but they will fulfilled informed consent for both methods.
The practitioner evaluating the CBCT results not know in which group the patients are.
Participants/Inclusion and exclusion criteria
Entry Requirements:
1)Patients with Unilateral Alveolar Defects
2)Patients in Mixed Dentition
Exit conditions:
1)Bilateral Alveolar Cleft
2)Presence of Systemic Diseases
3)Presence of Pathologic Disorders
4)History of Chemotherapy or Radiotherapy
5)History of Previous Failed Alveolar Graft.
Intervention groups
1)The intervention group includes patients with Unilateral Alveolar cleft who receive Chin Symphysis Bone Combination with Bone Allograft
2)The comparison group includes patients with Unilateral Alveolar cleft who receive anterior illic bone graft alone.
Main outcome variables
evaluation of Donor Site؛ evaluation of Complications Related to the Donor Site؛ Costs evaluation Compared to other Bone Regeneration Methods؛ evaluation the Duration of Surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210515051308N1
Registration date:2021-06-25, 1400/04/04
Registration timing:retrospective
Last update:2021-06-25, 1400/04/04
Update count:0
Registration date
2021-06-25, 1400/04/04
Registrant information
Name
Davood Davari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3234 9543
Email address
davari-d@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-03-21, 1396/01/01
Expected recruitment end date
2017-09-23, 1396/07/01
Actual recruitment start date
2017-03-21, 1396/01/01
Actual recruitment end date
2017-12-22, 1396/10/01
Trial completion date
2018-12-22, 1397/10/01
Scientific title
The success evaluation of bone grafts treatment in patients with unilateral alveolar cleft using mixture of allograft and symphisis bone compared to iliac bone graft alone
Public title
Evaluation of Alveolar Cleft Repair With Two Bone Grafting Methods
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with Unilateral Alveolar Cleft
Patients with Mixed Dentition
Informed Consent for Studing Treatment Methods
Exclusion criteria:
Bilateral alveolar cleft
History of previous surgery in the area
History of radiotherapy in the area
Existence of systemic disease
Age
From 8 years old to 14 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
22
Actual sample size reached:
22
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are selected by available sampling.
Simple randomization based on a table of random numbers will be done .
according to this participants will dividing into intervention and control groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
1)The Advantages and Disadvantages of Both Treatments Were Explained to Patients Who Entered the Study. Patients Entered the Treatment Phase with Informed Consent but Were Not Alert Which Method Will be Used in the Operation Room.
2)The Radiologists, Who Examined the Dimensions of the Alveolar Cleft and Repair Using CBCT, Did Not Alert Which Surgical Procedure Would be Used for the Patient.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Cleft Volume Measurement before Intervention and One Year after Surgery
Method of measurement
Cone-Beam Computed Tomography
Secondary outcomes
1
Description
Determining of Treatment Complications
Timepoint
1 Week, 1 Month, 3 Month, 6 Month, 1 Year after Intervention
Method of measurement
Clinical Inspection
Intervention groups
1
Description
Intervention group: Cortical bone fragments were extracted from the chin symphysis. For this purpose, sulcular incision of canine to canine was made in the mandible, 3 to 5 pieces of monocortical bone were extracted by a 6 mm trephine bur (Meisinger, Dusseldorf, Germany). The soft tissue incision was then sutured. A piece of the chin symphysis cortical bone was placed under the nasal mucosa. The other pieces were divided into smaller sizes and mixed with 2 to 5 mm allografts (Cenobone, Kish, Iran, two thirds autograft, one third allograft). The mixture filled the entire cleft area.
Category
Treatment - Surgery
2
Description
Control group: In these patients, a standard incision was used to access the anterior iliac crest. Based on the approximate size of the alveolar defect, a corticocancellous bone fragment was removed from the medial cortex of the anterior iliac crest by osteotome and mallet. The donor area (iliac) was sutured in three layers after washing. The extracted bone fragment was divided into smaller pieces and packed inside the alveolar defect so that a cortical wall was placed under the nasal mucosa.