Assessment of graft particle size effect in horizontal ridge augmentation with periosteal pocket flap.
Design
Parallel two-arm group randomized clinical trial with postoperative care and blind outcome evaluation. Excel software rand function was used for randomization.
Settings and conduct
In one group, large DFDBA bone particles and in the other group, small DFDBA bone particles are used for lateral ridge grafting. In both groups, the same surgical procedure using the periosteal pocket flap technique will be used. CBCT is prepared from patients before and 24 weeks after surgery and the amount of horizontal augmentation obtained between the two groups is calculated and compared.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients referred to the implant ward of Mashhad Dental School, Patients with insufficient bone volume for implant placement, Patients at least 20 years old.
Exclusion criteria: People who are not willing to continue cooperation, Patients who are absent from examinations and intend to place implants outside the faculty.
Intervention groups
Twenty patients with one or more extracted tooth areas and severe horizontal collapse of the alveolar ridge who are candidates for horizontal ridge augmentation are randomly divided into two groups of 10 patients. In one group, large DFDBA bone particles are used and in the other group, small DFDBA bone particles are used for lateral ridge grafting. In both groups, the same surgical procedure using the periosteal pocket flap technique will be used for horizontal ridge reconstruction. CBCT is prepared from patients before and 24 weeks after surgery and the amount of horizontal augmentation obtained between the two groups is calculated and compared. Also, the density of the formed bone is recorded and stored in radiography using Hansfield unit determination software.
Main outcome variables
The rate of bone formation.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210706051801N1
Registration date:2021-07-08, 1400/04/17
Registration timing:prospective
Last update:2021-07-08, 1400/04/17
Update count:0
Registration date
2021-07-08, 1400/04/17
Registrant information
Name
Hamidreza Arab
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3882 9501
Email address
arabhr@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-21, 1400/04/30
Expected recruitment end date
2021-11-21, 1400/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of bone powder size on horizontal ridge augmentation by periosteal pocket method
Public title
The effect of bone powder size on horizontal augmentation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients referred to the implant ward of Mashhad Dental School
Patients with insufficient bone volume for implant placement
Patients at least 20 years old
Exclusion criteria:
Patients who are not willing to continue cooperation
Patients who are absent from examinations and intend to place implants outside the faculty
Age
From 20 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method will be simple and unit of randomization will be individual. Randomization will be done using www.randomization.com and using random numbers in sealed envelopes. Based on the random number in the envelope and its evenness and individuality, the patient will belong to the test and control group.
Blinding (investigator's opinion)
Triple blinded
Blinding description
According to the study design, it is not possible to blind the researcher and the clinical caregiver. Study participants are not aware of the size of bone particles and patients' information is not provided to the outcome assessor and data analyzer.
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
Deputy of Research and Technology, Ghoreshi Building, next to Hoveyzeh Cinema, University Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2021-01-13, 1399/10/24
Ethics committee reference number
IR.MUMS.DENTISTRY.REC.1399.131
Health conditions studied
1
Description of health condition studied
One or more areas of the tooth are extracted and severe horizontal collapse of the alveolar ridge.
ICD-10 code
K08.2
ICD-10 code description
Atrophy of edentulous alveolar ridge
Primary outcomes
1
Description
The rate of bone formation.
Timepoint
CBCT was prepared from patients before and 24 weeks after surgery and the amount of horizontal agitation obtained between the two groups was calculated and compared.
Method of measurement
The bone density is recorded and stored on radiography using Hansfield unit determination software.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In one group, a small bone particle is used
Category
Treatment - Surgery
2
Description
Intervention group: In one group, a large bone particle is used and then the bone density is checked by cbct.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad Dental School
Full name of responsible person
Hamidreza Arab
Street address
Mashhad Dental school, Beginning Vakil Abad Blvd,
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3806 7100
Email
arabhr@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hamidreza Arab
Street address
Deputy of Research and Technology, Ghoreshi Building, next to Hoveyzeh Cinema, University Street.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
arabhr@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
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
Mashhad University of Medical Sciences
Full name of responsible person
Hamidreza Arab
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Deputy of Research and Technology, Ghoreshi Building, next to Hoveyzeh Cinema, University Street.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
arabhr@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hamidreza Arab
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Deputy of Research and Technology, Ghoreshi Building, next to Hoveyzeh Cinema, University Street.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
arabhr@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hamidreza Arab
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Deputy of Research and Technology, Ghoreshi Building, next to Hoveyzeh Cinema, University Street.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
arabhr@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD