Comparison of bone dimensional changes in immediate implant placement in mandibular premolars and/or molar sites with a horizontal gap more than 2 millimeters with or without graft: A Randomized clinical trial
The purpose of this study is to compare the clinical and radiographic effects of different types of bone grafts on alveolar bone dimensions after immediate implant placement.
Design
This double-blind parallel randomized clinical trial in phase 2-3 includes a total of 40 patients who have been randomly assigned to 4 groups.
Settings and conduct
The present study is a parallel randomized clinical trial with four arms. The study will be conducted in the fall of 1403 at the Faculty of Dentistry in Isfahan
Participants/Inclusion and exclusion criteria
The inclusion criteria for this study include age over 18 years, good oral hygiene, the presence of premolar or mandibular molar with hopeless prognosis due to severe caries or irreparable fracture
Intervention groups
Patients in the first group receive one immediate implant without graft material and without membrane. Patients in the second group receive one immediate implant with allograft and membrane. Patients in the third group receive one immediate implant with xenograft and membrane. The patients of the fourth group receive immediate implant with the equal ratio of combination of xenograft, allograft and membrane
Main outcome variables
To evaluate the vertical changes, the vertical distance between the implant shoulder and the crest of the buccal bone surface is measured along the longitudinal axis of the implant. If the bone is higher than the shoulder implant level, this situation is considered positive, but if the more apical bone is If the shoulder implant is placed, this situation is negative and they are evaluated in different groups. If there is a negative situation and the presence of bone resorption, a small reconstruction (Mini GBR) should be performed using autogenous bone in the vicinity of the resorption area, and the patient should be reevaluated 3 months later.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240924063148N1
Registration date:2024-10-04, 1403/07/13
Registration timing:prospective
Last update:2024-10-04, 1403/07/13
Update count:0
Registration date
2024-10-04, 1403/07/13
Registrant information
Name
Arsham Azarbad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3626 6898
Email address
arsham_azarbad@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-11-21, 1403/09/01
Expected recruitment end date
2024-11-30, 1403/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of bone dimensional changes in immediate implant placement in mandibular premolars and/or molar sites with a horizontal gap more than 2 millimeters with or without graft: A Randomized clinical trial
Public title
Comparison of bone dimensional changes in immediate implant placement
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age more than 18 years
Good oral hygiene
with optimal occlusion (without any parafunction)
Buccal bone thickness greater than 1 mm as previously measured by CBCT
Presence of mandibular premolar or molar with hopeless prognosis due to severe caries or irreparable fracture.
The presence of at least 2 mm of keratinized gingiva around the hopeless tooth
Exclusion criteria:
No entry of patients with suppressed immunity or immunodeficiency, such as patients with uncontrolled diabetes or with a history of head and neck radiotherapy
No entry of pregnant or lactating women
No entry of heavy smokers (more than 10 cigarettes per day)
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
After evaluating pre-surgery CBCTs, 40 patients who need to extract mandibular premolar and molar teeth and simultaneously place implants in these areas are included in the study. These patients will be assigned to one of 4 groups in a random block format in the form of 5 blocks of eight in which two people from each intervention will be present in each block. The way to choose the blocks is also based on the fact that the number of possible states of forming 8 blocks, which is a total of 2520 states, is determined by the Random Allocation Software 2.0 software, and five times out of these possible states, the block is selected randomly. In total, by choosing these five modes of blocks of 8, 40 patients will be assigned to 4 intervention groups based on the order of placement in the blocks and the selection of the blocks.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is done in a double-blind manner because the patient does not know which group he is placed in and the evaluator is also blinded, but it will be very difficult to blind the surgeon because the types of these transplant materials are recognizable from each other.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Schools of Dentistry, Health Sciences and Advanced Medical Technologie
Street address
Tohid
City
Esfahan
Province
Isfehan
Postal code
8173836630
Approval date
1997-02-11, 1375/11/23
Ethics committee reference number
IR.MUI.DHMT.REC.1403.105
Health conditions studied
1
Description of health condition studied
Comparison of bone dimensional changes in immediate implant placement in mandibular premolars and/or molar sites with a horizontal gap more than 2 millimeters with or without graft
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Horizontal and vertical bone dimensional changes
Timepoint
Before tooth extraction/just after implant placement/3 months after implant placement
Method of measurement
Radiographic evaluation to check the horizontal and vertical changes of buccal bone includes the use of CBCT scan before tooth extraction, right after implant placement and 3 months after implant placement. Through CBCT scan, the following items are evaluated: the vertical distance between the shoulder of the implant and the surface Buccal bone crest, buccal bone thickness and the distance between the buccal surface of the implant and the external surface of the buccal bone (the existing distance along with the thickness of the buccal bone).In these cases, the reference point for measuring the horizontal changes of the buccal bone is 1.5 mm more apical than the shoulder of the implant. To evaluate the vertical changes, the vertical distance between the shoulder of the implant and the crest of the buccal bone surface is measured along the longitudinal axis of the implant.
Secondary outcomes
empty
Intervention groups
1
Description
Patients in the second group receive one immediate implant with allograft and membrane
Category
Treatment - Surgery
2
Description
Patients in the third group receive one immediate implant with xenograft and membrane
Category
Treatment - Surgery
3
Description
Patients of the fourth group receive one immediate implant with an equal ratio of xenograft, allograft and membrane.
Category
Treatment - Surgery
4
Description
Control group: Patients in the first group receive one immediate implant without graft material
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Dental University of Medical Sciences
Full name of responsible person
Arsham azarbad
Street address
No42, tohid,
City
Isfahan
Province
Isfehan
Postal code
8173836630
Phone
+98 31 3626 6898
Fax
Email
arsham_azarbad@yahoo.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Vice President of Research and Technology of Isfahan University of Medical Sciences
Street address
Faculty of Dentistry, Isfahan
City
Esfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
edo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Arsham azarbad
Position
Residente
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No42, tohid
City
Isfahan
Province
Isfehan
Postal code
8173836630
Phone
+98 31 3626 6898
Fax
Email
arsham_azarbad@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Arsham azarbad
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No42, tohid
City
Isfahan
Province
Isfehan
Postal code
8173836630
Phone
+98 31 3626 6898
Fax
Email
arsham_azarbad@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Arsham azarbad
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No42, tohid
City
Isfahan
Province
Isfehan
Postal code
8173836630
Phone
+98 31 3626 6898
Fax
Email
arsham_azarbad@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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