The aim of this study was to compare the effect of Periosteal pocket flap technique with the gold standard technique, autogenous bone block on reconstruction of horizontal alveolar ridge defects.
Design
A controlled clinical trial with Individual block randomization with the random number tables with 24 sample sizes in 17 patients
Settings and conduct
The study was performed in the implant department of Mashhad Dental School. Patients were randomly divided into two groups. The periosteal pocket flap method was used in the intervention group with a horizontal incision on the periosteum. This space was then deepened using a periosteal elevator to completely separate the mucosa from the periosteum. Next, the periosteum with the periosteal elevator was raised over the bone to create a periosteal pocket between the bone and the periosteum. After biomaterial application including particulate allograft, collagen membrane was placed on the biomaterial inside the envelope. Membrane was then sutured to periosteum and buccal flap to palatal or lingual flap.
In the control group, bone was harvested from the ramus of the mandible and fixed with titanium screws in the target area. The gaps between the block and the receptor area were filled by particulate allografts and collagen membrane was placed on it. The buccal flap was then sutured to the palatal or lingual flap.
Participants/Inclusion and exclusion criteria
Inclusion criteria: edentulous area requiring horizontal bone reconstruction
Exclusion criteria: previous bone graft in the area, cigarette smoking, drug abuse
Intervention groups
The use of periosteal pocket flap in intervention group and autogenous bone block technique in control group
Main outcome variables
horizontal alveolar ridge augmentation in milimeter
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200105046011N1
Registration date:2020-02-15, 1398/11/26
Registration timing:retrospective
Last update:2020-02-15, 1398/11/26
Update count:0
Registration date
2020-02-15, 1398/11/26
Registrant information
Name
Leila Khodadadifard
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3760 7139
Email address
lkhodadadi1@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-06, 1398/01/17
Expected recruitment end date
2019-05-19, 1398/02/29
Actual recruitment start date
2019-04-06, 1398/01/17
Actual recruitment end date
2019-05-19, 1398/02/29
Trial completion date
2019-11-20, 1398/08/29
Scientific title
Comparison of Periosteal pocket flap technique with autogenous bone block for horizontal bone augmentation
Public title
Comparison of Periosteal pocket flap technique with autogenous bone block
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
edentulous area requiring horizontal bone reconstruction
Exclusion criteria:
previous bone graft in the area
cigarette smoking
drug abuse
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
17
More than 1 sample in each individual
Number of samples in each individual:
24
edentulous area requiring horizontal bone reconstruction
Actual sample size reached:
17
More than 1 sample in each individual
Actual sample size in each individual:
24
edentulous area requiring horizontal bone reconstruction
Randomization (investigator's opinion)
Randomized
Randomization description
Individual block randomization with the random number tables
Based on the CONSORT criteria, we coded the patients based on their number and assigned a random code to each patient. We put Periosteal pocket flap and autogenic block methods in the envelope and assign a special number to it randomly based on a random number table. Then we assign the envelope to the patient based on the patient code and random number and the procedure is performed by the surgeon.
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
Qom dental school, Qom university of medical science, Saheli Ave., Qom
City
Mashhad
Province
Razavi Khorasan
Postal code
3713649373
Approval date
2018-12-19, 1397/09/28
Ethics committee reference number
IR.MUMS.DENTISTRY.REC.1397.091
Health conditions studied
1
Description of health condition studied
horizontal alveolar ridge resorption
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
horizontal alveolar ridge augmentation in milimeter
Timepoint
before intervention, 26 weeks after surgery
Method of measurement
cone beam computed tomography survey
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Using the periosteal pocket flap method, after local anesthesia, a horizontal incision is made on the periosteum to create a small space between the periosteum and the mucosa. This space is then deepened using a periosteal elevator to completely separate the mucosa from the periosteum. Vertical releases are applied only to the mucosa if needed. The mucosal flap is then separated by the periosteal elevator over the mucogingival line, and the periosteum is then elevated from the bone to create a periosteal pocket between the bone and the periosteum. After biomaterial application including particulate allograft ine the size of 500-1000 micrometer (Regen Allograft- Iranian Tissue Product Company- Tehran-Iran), collagen membranes with 0.6-1 mm width (Regen Alloderm- Iranian Tissue Product Company- Tehran-Iran) are inserted over the biomaterial in the envelope. The buccal flap is then sutured to the palatal or lingual flap using the Vicryl 4-0 suture.
Category
Treatment - Surgery
2
Description
Control group: Bone block harvesting is done from the ramus mandibular area, then fixation of the block by titanium screws (JEIL Medical Corporation- Seoul-Korea). Flap tension is eliminated by applying periosteal-releasing at the buccal vestibule. The gaps between the block and the receptor area are filled by particulate allograft with a size of 500-1000 micrometer (Regen Allograft- Iranian Tissue Product Company- Tehran-Iran) and a collagen membrane with a width of 0.6-1 mm (Regen Alloderm-Iranian Tissue Product Company-Tehran-Iran) places over them. The buccal flap is then sutured to the palatal or lingual flap using the Vicryl 4-0 suture.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Implant section of Mashhad dental school
Full name of responsible person
Leila Khodadadifard
Street address
Qom dental school, Qom university of medical science, Saheli Ave., Qom
City
Mashhad
Province
Razavi Khorasan
Postal code
3713649373
Phone
+98 25 3770 0094
Email
l.khodadadifard@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Qom dental school, Qom university of medical science, Saheli Ave., Qom
City
Mashhad
Province
Razavi Khorasan
Postal code
3713649373
Phone
+98 25 3770 0094
Email
l.khodadadifard@gmail.com
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
Ghoum University of Medical Sciences
Full name of responsible person
Leila Khodadadifard
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Qom dentistry school, Qom university of medical science, Saheli street, Qom, Iran
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3770 0094
Fax
Email
l.khodadadifard@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Leila Khodadadifard
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Qom dentistry school, Qom university of medical science, Saheli street, Qom, Iran
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3770 0094
Fax
Email
l.khodadadifard@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Leila Khodadadifard
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Qom dentistry school, Qom university of medical science, Saheli street, Qom, Iran
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3770 0094
Fax
Email
l.khodadadifard@gmail.com
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Information of the age, sex, and width of the alveolar ridge before and after surgery as well as will be shared as well as the enhancement of the alveolar ridge width will be share.
When the data will become available and for how long
Start of access period 6 months after publishing the results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
The data can be used to conduct a similar study.
From where data/document is obtainable
Leila khodadadifard
Address: Qom dentistry school, Qom university of medical science, Qom, Iran
Email address: l.khodadadifard@gmail.com
What processes are involved for a request to access data/document
Sending an email request for data which containing information about the applicant for employment in academic and scientific institutions.
Data file will be sent by an email within one week.