Protocol summary
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Study aim
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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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Design
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Clinical trial with control group, with 2 parallel groups, double blinded, randomized on 26 patients. Coin flip will be used for randomization.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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Width of alveolar ridge
General information
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Reason for update
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Acronym
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IRCT registration information
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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
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Registration date
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2022-07-18, 1401/04/27
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-08-06, 1401/05/15
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Expected recruitment end date
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2022-10-07, 1401/07/15
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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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Public title
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Effect of Customized Healing Abutment on alveolar ridge contour
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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No age limit
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
26
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2022-07-02, 1401/04/11
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Ethics committee reference number
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IR.IAU.DENTAL.REC.1401.060
Health conditions studied
1
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Description of health condition studied
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Width of alveolar ridge
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ICD-10 code
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K08.2
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ICD-10 code description
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Atrophy of edentulous alveolar ridge
Primary outcomes
1
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Description
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Width of Alveolar Ridge
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Timepoint
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At the start of the research(before intervention) and 3 months later
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Method of measurement
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On the cast prepared after impression taken, using a gauge with an accuracy of 0.1 mm
Intervention groups
1
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Description
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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.
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Category
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Treatment - Devices
2
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Description
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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.
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Category
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Treatment - Devices
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Islamic Azad University
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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There is no further information
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available