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

Study Overview
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Brief Summary
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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

Official Title
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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. A 1-Year Randomized Clinical Trial

Conditions
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Tissue Collapse, Immediate Implant, Esthetic Zone, Customized Healing Abutment, Tissue Dimensional Changes

Intervention / Treatment
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* Procedure: immediate implant placement with customized healing abutment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: immediate implant placement with customized healing abutment<br> | Procedure: immediate implant placement with customized healing abutment<br>* immediate implant placement with customized healing abutment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of labiopalatal ridge collapse | radiographic Labiopalatal ridge collapse via CBCT | 1 year | 
| 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 | 1 year | 

Secondary Outcome Measures

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