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Effect of Tooth Angulation, Alveolar and Basal Bone Anatomical Characteristics on Soft and Hard Tissue Alterations Around Immediate Implants With Customized Healing Abutment

Primary Purpose

Immediate Implant, Esthetic Zone, Customized Healing Abutment

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
immediate implant placement with customized healing abutment
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Immediate Implant

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Patient-related criteria: Adults at or above the age of 21. Non-restorable maxillary inter-canine tooth requiring extraction and needed an implant placing therapy. The failing tooth will have adjacent and opposing natural teeth. Sufficient mesial-distal and interocclusal space for placement of the implant and definitive restoration. Able to tolerate surgical periodontal procedures. Good oral hygiene. Compliance with the maintenance program. Provide informed consent. Accepts the one-year follow-up period. Teeth related criteria: Intact thick biotype gingival tissue with at least 2mm band of keratinized tissue. Intact socket wall before the extraction, buccal bone thickness ≤1mm assessed by CBCT. Sufficient apical bone to place an immediate implant with minimum primary stability of 30Ncm. Exclusion criteria: Patients diagnosed with periodontal diseases. Current or previous smokers. Pregnant and lactating females. Patients with medical conditions that would compromise the surgical procedures; uncontrolled diabetes mellitus, taking IV Bis-phosphonates for treatment of osteoporosis. Patients with active infection related at the site of implant/bone graft placement. Patients with parafunctional habits

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    immediate implant placement with customized healing abutment

    Arm Description

    Outcomes

    Primary Outcome Measures

    Amount of labiopalatal ridge collapse
    radiographic Labiopalatal ridge collapse via CBCT
    Amount of bone labial to the implant
    Amount of bone labial to the implant at three levels 0, 2, and 5mmm below the alveolar crest via CBCT

    Secondary Outcome Measures

    Amount of vertical crestal bone resorption in millimeters
    Vertical crestal bone changes via CBCT in mm
    Amount of change in buccal soft issue contour in mm3
    volumetric analysis of the amount of change in buccal soft issue contour in mm3
    amount of Mid facial recession in millimeters
    Mid facial recession in n millimeters
    Pink esthetic score
    1-14 scale

    Full Information

    First Posted
    September 4, 2023
    Last Updated
    September 10, 2023
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06040788
    Brief Title
    Effect of Tooth Angulation, Alveolar and Basal Bone Anatomical Characteristics on Soft and Hard Tissue Alterations Around Immediate Implants With Customized Healing Abutment
    Official Title
    Effect of Tooth Angulation, Alveolar and Basal Bone Anatomical Characteristics on Soft and Hard Tissue Alterations Around Immediate Implants With Customized Healing Abutment. A 1-Year Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    September 2024 (Anticipated)
    Study Completion Date
    November 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The goal of this clinical trial is to investigate the effect of different anatomical variations in terms of root angulation, alveolar bone and basal bone morphology on soft and hard tissue alterations in patients with non-restorable teeth in the inter-canine region undergoing immediate implantation. The main question it aims to answer are: Will the amount of collapse be greater when the root is proclined or outside the bone housing? Will no additional intervention be needed with immediate implants in the esthetic zone if we have better anatomy that will help hinder the collapse? Participants will receive immediate dental implants with customized healing abutments

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Immediate Implant, Esthetic Zone, Customized Healing Abutment, Tissue Collapse, Tissue Dimensional Changes

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    immediate implant placement with customized healing abutment
    Arm Type
    Experimental
    Intervention Type
    Procedure
    Intervention Name(s)
    immediate implant placement with customized healing abutment
    Intervention Description
    immediate implant placement with customized healing abutment
    Primary Outcome Measure Information:
    Title
    Amount of labiopalatal ridge collapse
    Description
    radiographic Labiopalatal ridge collapse via CBCT
    Time Frame
    1 year
    Title
    Amount of bone labial to the implant
    Description
    Amount of bone labial to the implant at three levels 0, 2, and 5mmm below the alveolar crest via CBCT
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Amount of vertical crestal bone resorption in millimeters
    Description
    Vertical crestal bone changes via CBCT in mm
    Time Frame
    1 year
    Title
    Amount of change in buccal soft issue contour in mm3
    Description
    volumetric analysis of the amount of change in buccal soft issue contour in mm3
    Time Frame
    1 year
    Title
    amount of Mid facial recession in millimeters
    Description
    Mid facial recession in n millimeters
    Time Frame
    1 year
    Title
    Pink esthetic score
    Description
    1-14 scale
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patient-related criteria: Adults at or above the age of 21. Non-restorable maxillary inter-canine tooth requiring extraction and needed an implant placing therapy. The failing tooth will have adjacent and opposing natural teeth. Sufficient mesial-distal and interocclusal space for placement of the implant and definitive restoration. Able to tolerate surgical periodontal procedures. Good oral hygiene. Compliance with the maintenance program. Provide informed consent. Accepts the one-year follow-up period. Teeth related criteria: Intact thick biotype gingival tissue with at least 2mm band of keratinized tissue. Intact socket wall before the extraction, buccal bone thickness ≤1mm assessed by CBCT. Sufficient apical bone to place an immediate implant with minimum primary stability of 30Ncm. Exclusion criteria: Patients diagnosed with periodontal diseases. Current or previous smokers. Pregnant and lactating females. Patients with medical conditions that would compromise the surgical procedures; uncontrolled diabetes mellitus, taking IV Bis-phosphonates for treatment of osteoporosis. Patients with active infection related at the site of implant/bone graft placement. Patients with parafunctional habits

    12. IPD Sharing Statement

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    Effect of Tooth Angulation, Alveolar and Basal Bone Anatomical Characteristics on Soft and Hard Tissue Alterations Around Immediate Implants With Customized Healing Abutment

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