Protocol summary

Study aim
Immediate implantation has benefits for the patient. The use of this method has been proven in the posterior area, but few studies have investigated immediate implantation in the cosmetic area, therefore, due to the lack of clinical reports, the purpose of this study is to evaluate two methods of anatomical and usual immediate implantation in the esthetic area
Design
Randomization is not done in this study The sample size is at least 24 people Groups receive treatment in parallel.
Settings and conduct
The patients referred to the periodontics specialist department of the Dental Clinic of Islamic Azad University of Isfahan. Blinding was not done in this study. In the present study, there are two groups of patients, all of whom are treated by a resident under the supervision of a periodontics specialist.
Participants/Inclusion and exclusion criteria
A patient who has a tooth in the anterior region of the upper jaw that has an indication for tooth extraction and has the entry criteria. Choosing the right case is done through clinical evaluation and radiography (periapical and CBCT) before the operation. A thorough clinical and radiographic evaluation should be performed before immediate implant placement. Preferably, a CBCT graph should be obtained from the concerned areas. In the prepared graph, the thickness of the buccal plate is evaluated.
Intervention groups
In this study, patients are divided into two groups: experimental and control. However, their placement in these two groups is non-random and the method of implantation is based on the patient's dental conditions.
Main outcome variables
The buccolingual position /Mesiodistal position/Epicochronal position mesiodistal angle/The buccolingual angle/Implantation method Initial stability

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240212060982N1
Registration date: 2024-08-22, 1403/06/01
Registration timing: prospective

Last update: 2024-08-22, 1403/06/01
Update count: 0
Registration date
2024-08-22, 1403/06/01
Registrant information
Name
Navid Asghari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 936 718 6887
Email address
dent.asghari@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-22, 1403/07/01
Expected recruitment end date
2024-11-21, 1403/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the ideal position of the implant in two conventional and anatomical methods of immediate placement in aesthetic areas
Public title
Comparison of the ideal position of the implant in the aesthetic area
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
A patient who has a tooth in the anterior region of the upper jaw that has an indication for tooth extraction The patient is systemically healthy Good oral hygiene The patient's gingival biotype is thick and the buccal wall is quiet and healthy The lateral teeth (the teeth in the distal and mesial part of the implant) are healthy and do not have extensive caries, crowding or restoration. The patient's occlusion is appropriate and there is no obvious crossbite or overbite
Exclusion criteria:
Use of cigarettes and tobacco Presence of periodontitis and gum analysis Having a history of radiotherapy The presence of active infection in the dental cavity
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 24
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 Islamic Azad University - Isfahan Branch (Khorasgan)
Street address
No. 7, Sadat Quay, Golestan St., Golestan St., Shahadai Sattar Blvd., J Street, Khorasgan City, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8159144851
Approval date
2024-05-29, 1403/03/09
Ethics committee reference number
IR.IAU.KHUISF.REC.1403.081

Health conditions studied

1

Description of health condition studied
The subject of the study is not a disease and two methods of implantation
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Initial stability
Timepoint
Immediately after implantation
Method of measurement
Stability: Torque (cm)

2

Description
Angle and position of the implant
Timepoint
Immediately after implantation
Method of measurement
MM

Secondary outcomes

1

Description
The convenience of the method used by the surgeon
Timepoint
After surgery
Method of measurement
Qualitative

Intervention groups

1

Description
Intervention group: Anatomical implant recipient
Category
Treatment - Surgery

2

Description
Control group: The recipient of the implant in the usual way
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Faculty of Dentistry, Islamic Azad University, Khorasgan branch
Full name of responsible person
Navid Asghari
Street address
Plate 7, Sadat Quay, Golestan Street, Shahadai Sattar Blvd., J Street, Khorasgan City, Isfahan.
City
Isfahan
Province
Isfehan
Postal code
8159144851
Phone
+98 936 718 6887
Email
dent.asghari@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Amir Mansour Shirani
Street address
University Blvd., Arghwanieh., J Sharghi St., Isfahan
City
Isfahan
Province
Isfehan
Postal code
81551-39998
Phone
+98 31 3535 4001
Email
info@khuisf.ac.ir
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
Navid Asghari
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Plate 7, Koi Sadat, Golestan Street, Shahadai Sattar Blvd., Khorasagan City
City
Isfahan
Province
Isfehan
Postal code
8159144851
Phone
+98 936 718 6887
Email
dent.asghari@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Navid Asghari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
7, Koi Sadat., Golestan Street., Khorasagan City
City
Isfahan
Province
Isfehan
Postal code
8159144851
Phone
+98 936 718 6887
Email
dent.asghari@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Navid Asghari
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Plate 7, Koi Sadat, Golestan Street, Shahadai Sattar Blvd., Khorasagan City
City
Isfahan
Province
Isfehan
Postal code
۸۱۵۹۱۴۴۸۵۱
Phone
+98 936 718 6887
Email
dent.asghari@yahoo.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
In expressing the results of the study, there is no need for the personal information of the participants
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
After obtaining the results from the examination of the two groups, conclusions are made about the stability, position, and angle of the implant, and the results are made available to others.
When the data will become available and for how long
There is access to data 4 months after preparing the thesis.
To whom data/document is available
Technicians who perform implant placement and related dental students and residents can access this data.
Under which criteria data/document could be used
It is possible to use the results of the study to compare with other studies and newer methods
From where data/document is obtainable
The results of the study are available in the form of a thesis in the library of the Faculty of Dentistry of Islamic Azad Unit, and the research article is also available in the related journal.
What processes are involved for a request to access data/document
After the request, the applicant can have access to the documents after a few days.
Comments
There is no specific explanation.
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