Radiographic evaluation of the changes in alveolar ridge dimensions after immediate implant placement with and without the use of bone materials in a 4-months follow-up. Evaluation of the changes in the thickness of the buccal bone plate, buccal gap distance and the width buccolingual ridge, 2 days and 4 months later of implant placement in the 0 , 2 and 4 mm from the implant platform, by cone-beam computed tomography in both groups.
Design
The clinical trial has a control group with randomized parallel groups without blinding, phase 2-3 on 30 implants, 15 implants in the test and the 15 implants in the control group.
Settings and conduct
Our patients include those who refer to Shahed Dental School and a private clinic, who need their teeth extracted and immediate implant placement. Before the operation, 0.2% chlorhexidine mouthwash is given for 60 seconds. After injection of anesthesia with 1/100000 lidocaine, atraumatic extraction of the tooth is performed in a flapless manner, and the silent walls are evaluated to confirm the health of the buccal bone plate . Drilling is done in order to place the bone level implant in the correct position and the implants are inserted in the lingual position and at a distance from the buccal plate.
Participants/Inclusion and exclusion criteria
Patients needing extraction and immediate implant placement without uncontrolled systemic disease, and with a intact buccal plate of the tooth after extraction.
Intervention groups
The use of bone graft material in the buccal distance gap in the test group and the blood clot filling in the control group are evaluated by radiography.
Main outcome variables
Buccal plate thickness; the buccal gap distance from the inner wall of the buccal plate to the external surface of the implant and the width of ridge buccolingual in the implant platform and 2 and 4 mm more apically were measured with using CBCT.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221218056849N1
Registration date:2023-01-28, 1401/11/08
Registration timing:retrospective
Last update:2023-01-28, 1401/11/08
Update count:0
Registration date
2023-01-28, 1401/11/08
Registrant information
Name
hasan Semyari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2248 5673
Email address
h.semyari@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-20, 1401/06/29
Expected recruitment end date
2023-01-19, 1401/10/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of alveolar ridge dimension changes after immediate implant placement with and without bone grafting
Public title
Evaluation of using bone material effects by Immediate implant placement
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
No Systemic disease
Intact buccal bone plate
Exclusion criteria:
Uncontrolled systemic disease
Heavy smoking
The buccal bone plate loss
Pregnancy and breastfeeding
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
30
More than 1 sample in each individual
Number of samples in each individual:
2
30 implant in 15 patient
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the block randomization method is used, so that thirty teeth with intact buccal bone plate selected that they need to extract and fresh socket implantation, they are divided into two groups of 15, such that odd teeth with odd numbers are in the first group and the teeth with even numbers are in the second group. In the first group, bone powder is placed at the same time as immediate implant insertion and don't use bone powder in the second group.There is no possibility of blinding the surgeon and the radiologist in this study, because it is obvious that the use and non-use of bone graft can be seen for both.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this study, allograft bone graft materials made in Iran are used in gap distance the immediate implant.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahed University
Street address
No 71,itally street , Shahed School of Dentistry ,tehran iran
City
Tehran
Province
Tehran
Postal code
1417755366
Approval date
2021-11-01, 1400/08/10
Ethics committee reference number
IR.SHAHED.REC.1400.094
Health conditions studied
1
Description of health condition studied
Changes in buccal plate thickness and buccal gap with immediate implant insertion
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Buccal gap distance in immediate implant
Timepoint
2 days and four months later
Method of measurement
CBCT radiology device
2
Description
The width of the buccolingual ridge
Timepoint
2 days and four months later
Method of measurement
CBCT radiology device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this study, after inserting bone level immediate implant, buccal gap in the immediate implant filling with bone powder of the Iranian tissue products (Regen) with a size of 500-1000, and then the location of the surgery with healing abutment and stitching .
Category
Treatment - Surgery
2
Description
Control group: In this study, after inserting bone level immediate implant, buccal gap in the immediate implant is filled naturally with blood clot and without using bone powder, and then the surgical site is closed with a healing abutment and suture.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahed dental university and a private clinic
Full name of responsible person
Hasan Semyari
Street address
No 71, Shahed Dental School, Italy street
City
Tehran
Province
Tehran
Postal code
1417755366
Phone
+98 21 8898 6053 ext. 09123194993
Email
h.semyari@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahed University
Full name of responsible person
Dr. Shahryar Bijani
Street address
Persian Gulf highway in front of Imam Khomeini shrine
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 5105
Email
bijani@shahed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahed University
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
Shahed University
Full name of responsible person
Hasan Semyari
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No 71, Shahed Dental School, Italy street
City
Tehran
Province
Tehran
Postal code
1417755366
Phone
+98 21 8898 6053
Email
h.semyari@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Hasan Semyari
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No 71, Shahed Dental School, Italy street
City
Tehran
Province
Tehran
Postal code
1417755366
Phone
+98 21 8898 6053
Fax
Email
h.semyari@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Tahereh Sahraei
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No 71, Shahed Dental School, Italy street
City
Tehran
Province
Tehran
Postal code
1417755366
Phone
+98 21 8896 8296
Email
drsahraeit@gmail.com
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
The principle of protecting the medical secrets of patients
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available