Determination of alveolar bone loss in one stage immediate implant surgery
Determination of alveolar bone loss in two stage immediate implant surgery
Comparison of alveolar bone loss in one and two stage immediate implant surgical
Design
Clinical trial with 2 intervention groups, with parallel groups, semi-randomized, without blinding on 70 patients
Settings and conduct
According to the entry and exit criteria, patients will enter the study. Parallel and panoramic periapical radiography will be taken from the patients. The implant site will be prepared and the fixtures will be used. Then parallel periapical radiographs are taken immediately after the surgery. 6 months after the completion of the patient's surgery, parallel periapical images are taken from the patients.Marginal bone analysis will be calculated using Adobe Photoshop CS5 software.
Participants/Inclusion and exclusion criteria
Entry requirements : Healthy patients with good oral and dental health status (plaque index below 25%)
No history of chronic systemic diseases
A candidate for implant surgery in the anterior area of the maxillary
Non-entry conditions :
Presence of chronic systemic disease
Tooth with periapical lesion
smoking
bruxism
Uncontrolled or insulin-dependent diabetes
Oral and dental diseases
Intervention groups
Candidate patients for implant surgery in the anterior region of the maxilla in fresh-socket form and in the same treatment session as tooth extraction.
Main outcome variables
Investigating the amount of bone loss using parallel periapical radiographs in both groups, before and after surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240705062331N1
Registration date:2024-07-21, 1403/04/31
Registration timing:retrospective
Last update:2024-07-21, 1403/04/31
Update count:0
Registration date
2024-07-21, 1403/04/31
Registrant information
Name
Saber Eskandari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2276 1513
Email address
saberesk@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-22, 1402/10/01
Expected recruitment end date
2024-07-20, 1403/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determination of alveolar bone loss in one and two stage immediate implant surgery
Public title
Investigation the rate of bone loss in immediate implants
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy patients with good oral and dental health status (plaque index below 25%)
No history of chronic systemic diseases
A candidate for implant surgery in the anterior area of the upper jaw (3 to 3) in the form of fresh-socket
Exclusion criteria:
Presence of chronic systemic disease
Tooth with periapical lesion
smoking
bruxism
Uncontrolled or insulin-dependent diabetes
Oral and dental diseases
Coagulation disorders
Consumption of alcohol and bisphosphonate drugs
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Azad University of Dentistry, Tehran branch
Street address
University of Dentistry, Nistan 9th St., Pasdaran, Tehran
City
Tehran
Province
Tehran
Postal code
1946853314
Approval date
2024-06-22, 1403/04/02
Ethics committee reference number
IR.IAU.DENTAL.REC.1403.076
Health conditions studied
1
Description of health condition studied
Determination of alveolar bone loss in one and two stage immediate implant surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The rate of bone loss
Timepoint
Before surgery. 6 months after surgery
Method of measurement
Adobe Photoshop CS5 software
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: healthy patients with good oral and dental health status (plaque index below 25%), without history of chronic systemic diseases, are candidates for implant surgery in the anterior region of the upper jaw (3 to 3) in the form of fresh-socket. For some patients, a one-step implant will be performed. The location of the implants will be chosen so that there is at least 4 mm of bone behind the apex of the root and 1-2 mm of palatal and facial bone width, and the distance of the implant in all cases is less than 2 mm to the silent walls of the tooth to ensure stability. The primary implant, tooth extraction without trauma and minimum force of 35 N/CM should be ensured. In order to reduce the trauma as much as possible, the elevator and periotum will be used so as to cause the least amount of damage to the bone. After tooth extraction, the socket is carefully cut, then the implant bed will be prepared. Using standard drills, the implant site is prepared and fixtures with a diameter of 3.9±2.0 will always be placed at least 4 mm behind the apex of the root and 1-2 mm wide of the palatal and facial bones. Parallel periapical radiographs are taken immediately after surgery. 6 months after surgery, parallel periapical images are taken from patients and the amount of bone loss in millimeters will be measured using Adobe Photoshop CS5 software.
Category
Treatment - Surgery
2
Description
Intervention group: healthy patients with good oral and dental health status (plaque index below 25%), without history of chronic systemic diseases, are candidates for implant surgery in the anterior region of the upper jaw (3 to 3) in the form of fresh-socket. A number of patients will have a two-stage implant. The location of the implants will be selected so that there is at least 4 mm of bone beyond the apex of the root and 1-2 mm of the width of the palatal and facial bone, and the distance of the implant in all cases is less than 2 mm to the silent walls of the tooth in order to ensure stability. Initial implant, tooth extraction without trauma and minimum force of 35 N/CM should be ensured. In order to reduce the trauma as much as possible, the elevator and periotoum will be used to minimize the damage to the bone. After tooth extraction, the socket is carefully cut, then the implant bed will be prepared. Using standard drills, the implant site is prepared and fixtures with a diameter of 3.9±2.0 will always be placed at least 4 mm behind the apex of the root and 1-2 mm wide of the palatal and facial bones. Parallel periapical radiographs are taken immediately after the surgery. 6 months after the second surgery, parallel periapical images are taken from the patients and the amount of bone loss in millimeters will be measured using Adobe Photoshop CS5 software.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Azad University of Dentistry, Tehran branch
Full name of responsible person
Leila Derakhshan
Street address
Azad University of Dentistry, Nistan 9th St, Pasdaran, Tehran
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
Public.relation.of.dentistry@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Afshin Haraji
Street address
Azad University of Dentistry, Nistan 9th St., Pasdaran, Tehran
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
Public.relation.of.dentistry@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad 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
Islamic Azad University
Full name of responsible person
Saber Eskandari
Position
Dentistry student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No:40.Fatahian street.Ekhtiarieh square.Tehran
City
Tehran
Province
Tehran
Postal code
1956674993
Phone
+98 21 2276 1513
Email
Saberesk@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Saber Eskandari
Position
Dentistry student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No:40.Fatahian s.Ekhtyarieh squ.Pasdaran.Tehran
City
Tehran
Province
Tehran
Postal code
1958674993
Phone
+98 21 2276 1513
Email
Saberesk@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Saber Eskandari
Position
Dentistry student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No:40.Fatahian s.Ekhtiarieh squ.Pasdaran s.Tehran
City
Tehran
Province
Tehran
Postal code
1958674993
Phone
+98 21 2276 1513
Email
Saberesk@yahoo.com
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