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The effect of Customized Healing Abutment and Conventional Healing Abutment on preservation of alveolar ridge contour in immediate posterior implants

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History
# Registration date Revision Id
2 2022-07-27, 1401/05/05 234766
1 2022-07-18, 1401/04/27 233788
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  • Recruitment centers

    #1
    Name of recruitment center - English: Islamic Azad university dental branch Tehran
    Name of recruitment center - Persian: دانشکده دندانپزشکی آزاد اسلامی تهران
    Full name of responsible person - English: Elahe Soltani
    Full name of responsible person - Persian: الهه سلطانی
    Street address - English: No.9 , Neyestan Ave, Pasdaran Blvd
    Street address - Persian: خیابان پاسداران، نیستان نهم، پلاک 9
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1946853314
    Phone: +98 21 2256 4571
    Fax:
    Email: info@iau.ac.ir.university
    Web page address: https://tms.iau.ir/dental/fa
    Name of recruitment center - English: Islamic Azad University Dental Branch Tehran
    Name of recruitment center - Persian: دانشکده دندانپزشکی آزاد اسلامی تهران
    Full name of responsible person - English: Dr. Nima Naddafpour
    Full name of responsible person - Persian: دکتر نیما نداف پور
    Street address - English: No.9 , Neyestan Ave, Pasdaran Blvd
    Street address - Persian: خیابان پاسداران، نیستان نهم، پلاک 9
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1946853314
    Phone: +98 21 2256 4571
    Fax:
    Email: nima.na04@gmail.com
    Web page address:

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Elahe Soltani
    Full name of responsible person - Persian: الهه سلطانی
    Street address - English: No.9 , Neyestan Ave, Pasdaran Blvd
    Street address - Persian: پاسداران، نیستان نهم، پلاک 9
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1946853314
    Phone: +98 21 2256 4571
    Fax:
    Email: info@iau.ac.ir.university
    Web page address: https://tms.iau.ir/dental/fa

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Arash Azizi
    Full name of responsible person - Persian: آرش عزیزی
    Street address - English: No.9 , Neyestan Ave, Pasdaran Blvd
    Street address - Persian: پاسداران، نیستان نهم، پلاک 9
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1946853314
    Phone: +98 21 2258 0925
    Fax:
    Email: drarashazizi@yahoo.com
    Web page address:

  • Person responsible for general inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Elahe Soltani
    Full name of responsible person - Persian: الهه سلطانی
    Position - English: Student
    Position - Persian: دانشجو
    Latest degree: a_level
    Area of specialty/work: 43
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: No. 82 , East 180th Ave, Tehranpars, Tehran city
    Street address - Persian: شهر تهران، تهرانپارس، خیابان 180 شرقی، پلاک82
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1655965784
    Phone: +98 21 7770 9604
    Mobile: +98 901 347 0854
    Fax:
    Email: elaahesoltaani@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr. Nima Naddafpour
    Full name of responsible person - Persian: دکتر نیما نداف پور
    Position - English: Periodontist
    Position - Persian: متخصص پریودانتیکس
    Latest degree: specialist
    Area of specialty/work: 43
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: No.9 , Neyestan 9 Ave, Pasdaran Ave
    Street address - Persian: خیابان پاسداران، خیابان نیستان 9 ، پلاک 9
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1946853314
    Phone: +98 21 2256 4571
    Mobile: +98 912 288 9128
    Fax:
    Email: nima.na04@gmail.com
    Web page address:

  • Person responsible for scientific inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Elahe Soltani
    Full name of responsible person - Persian: الهه سلطانی
    Position - English: Student
    Position - Persian: دانشجو
    Latest degree: a_level
    Area of specialty/work: 43
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: No.82, East 180th street, Tehranpars, Tehran city
    Street address - Persian: شهر تهران، تهرانپارس، خیابان 180 شرقی، پلاک 82
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1655965784
    Phone: +98 21 7770 9604
    Mobile: +98 901 347 0854
    Fax:
    Email: elaahesoltaani@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr. Nima Naddafpour
    Full name of responsible person - Persian: دکتر نیما نداف پور
    Position - English: Periodontist
    Position - Persian: متخصص پریودانتیکس
    Latest degree: specialist
    Area of specialty/work: 43
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: No.9 , Neyestan 9 Ave, Pasdaran Ave
    Street address - Persian: خیابان پاسداران، خیابان نیستان 9 ، پلاک 9
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1946853314
    Phone: +98 21 2256 4571
    Mobile: +98 912 288 9128
    Fax:
    Email: nima.na04@gmail.com
    Web page address:

  • Person responsible for updating data


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Elahe Soltani
    Full name of responsible person - Persian: الهه سلطانی
    Position - English: Student
    Position - Persian: دانشجو
    Latest degree: a_level
    Area of specialty/work: 43
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: No.82, East 180th street, Tehranpars, Tehran city
    Street address - Persian: شهر تهران، تهرانپارس، خیابان 180 شرقی، پلاک 82
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1655965784
    Phone: +98 21 7770 9604
    Mobile: +98 901 347 0854
    Fax:
    Email: elaahesoltaani@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr. Nima Naddafpour
    Full name of responsible person - Persian: دکتر نیما نداف پور
    Position - English: Periodontist
    Position - Persian: متخصص پریودانتیکس
    Latest degree: specialist
    Area of specialty/work: 43
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: No.9 , Neyestan 9 Ave, Pasdaran Ave
    Street address - Persian: خیابان پاسداران، خیابان نیستان 9 ، پلاک 9
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1946853314
    Phone: +98 21 2256 4571
    Mobile: +98 912 288 9128
    Fax:
    Email: nima.na04@gmail.com
    Web page address:

Protocol summary

Study aim
The effect of Customized Healing Abutment and Conventional Healing Abutment on preservation of alveolar ridge contour in immediate posterior implants
Design
Clinical trial with control group, with 2 parallel groups, double blinded, randomized on 26 patients. Coin flip will be used for randomization.
Settings and conduct
Patients are selected from the patients of Islamic Azad University Dental Branch and divided into 2 groups based on Coin flip. The clinical supervisor, who is a specialist in periodontics, performs the surgery and doesn’t inform the participants, the researcher and the outcome assessor about which group each patient is in.
Participants/Inclusion and exclusion criteria
The inclusion criteria are: The patient has a hopeless tooth. They should not have periodontal disease or significant recession. They should agree the study conditions and sign the testimonial. The exclusion criteria are: The systemic or psychological conditions that are implant placement contraindications. When there is not intact bone wall in dental socket after extraction. The patient is not compliant. They are heavy smoker ( more than 10 cigarettes per day) They have bruxism or destructive para-functional habits. The primary stability is below 20.
Intervention groups
For the control group, on the surgery day, after placing the Osstem implant made by south Korea, Conventional Healing Abutment is placed and the region will be sutured. For the intervention group,on the surgery day, after placing the Osstem implant made by south Korea, Customized Healing Abutment is placed and formed to the socket shape of the desired tooth by light cure composite and the region will be sutured.
Main outcome variables
Width of alveolar ridge

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220702055345N1
Registration date: 2022-07-18, 1401/04/27
Registration timing: prospective

Last update: 2022-07-27, 1401/05/05
Update count: 1
Registration date
2022-07-18, 1401/04/27
Registrant information
Name
Elahe Soltani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7770 9604
Email address
elaahesoltaani@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-06, 1401/05/15
Expected recruitment end date
2022-10-07, 1401/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Customized Healing Abutment and Conventional Healing Abutment on preservation of alveolar ridge contour in immediate posterior implants
Public title
Effect of Customized Healing Abutment on alveolar ridge contour
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patient has a hopeless tooth They should not have periodontal disease or significant recession They should agree the study conditions and sign the testimonial
Exclusion criteria:
The systemic or psychological conditions that are implant placement contraindications There is not intact bone wall in dental socket after extraction The patient is not compliant The patient is a heavy smoker ( more than 10 cigarettes per day) The patient has bruxism or destructive para-functional habits The primary stability is below 20
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 26
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization is done by coin-flip. The customized healing abutment group is considered as heads and the Conventional Healing Abutment group is considered as tails. A coin is tossed and patients are assigned to two random groups.
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
Research ethics committees of Islamic Azad University Dental Branch Tehran Iran
Street address
No. 9 , Neyestan Ave, Pasdaran Blvd
City
Tehran
Province
Tehran
Postal code
1946853314
Approval date
2022-07-02, 1401/04/11
Ethics committee reference number
IR.IAU.DENTAL.REC.1401.060

Health conditions studied

1

Description of health condition studied
Width of alveolar ridge
ICD-10 code
K08.2
ICD-10 code description
Atrophy of edentulous alveolar ridge

Primary outcomes

1

Description
Width of Alveolar Ridge
Timepoint
At the start of the research(before intervention) and 3 months later
Method of measurement
On the cast prepared after impression taken, using a gauge with an accuracy of 0.1 mm

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: On the surgery day, after placing the Osstem implant brand, made in South Korea, the Healing Abutment is placed on it and the light cure composite around it is shaped into the socket shape of the desired tooth and the region will be sutured.
Category
Treatment - Devices

2

Description
Control group: On the surgery day after placing the Osstem implant brand, made in South Korea, only the Healing Abutment is placed on it and the region will be sutured.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Islamic Azad University Dental Branch Tehran
Full name of responsible person
Dr. Nima Naddafpour
Street address
No.9 , Neyestan Ave, Pasdaran Blvd
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
nima.na04@gmail.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Arash Azizi
Street address
No.9 , Neyestan Ave, Pasdaran Blvd
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2258 0925
Email
drarashazizi@yahoo.com
Web page address
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
Dr. Nima Naddafpour
Position
Periodontist
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No.9 , Neyestan 9 Ave, Pasdaran Ave
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
nima.na04@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Nima Naddafpour
Position
Periodontist
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No.9 , Neyestan 9 Ave, Pasdaran Ave
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Fax
Email
nima.na04@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Nima Naddafpour
Position
Periodontist
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No.9 , Neyestan 9 Ave, Pasdaran Ave
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Fax
Email
nima.na04@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
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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