Immediate Implant Outcomes With and Without Bone Augmentation

Study Overview
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Brief Summary
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To evaluate immediate implant placement feasibility and esthetic outcomes in severely damaged sockets that received simultaneously bone reconstruction (cortical bone shield) and implant placement versus intact sockets that needed no reconstruction and had immediate implant placement.

Detailed Description
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The present clinical trial aims at demonstrating facial bone regeneration on sites that presented large buccal bone dehiscences & vertical bone loss and evaluate the feasibility of performing simultaneous bone augmentation and implant placement, comparing the outcomes with sites that had intact sockets that did not require reconstruction. A secondary objective was to evaluate pink esthetics and marginal bone levels at final follow-up.

Official Title
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Immediate Implants in Damaged Sockets With Simultaneous Bone Reconstruction vs. Immediate Implants in Intact Sockets and no Reconstruction

Conditions
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Tooth Loss, Bone Loss, Alveolar, Dental Diseases, Dental Trauma

Intervention / Treatment
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* Procedure: implant placement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: individuals 20 Years and older Patients requiring single implants to replace missing teeth to restore masticatory function and esthetics. ASA1 or ASA2 (American Society of Anesthesiologists) Healthy individuals with good oral hygiene and motivation No systemic uncontrolled diseases Not taking drugs known to modify bone metabolism Exclusion Criteria: Individuals with untreated & generalized severe periodontitis Smokers (>5 cigarettes/day) Poor oral hygiene Diabetes (HbA1C >6.5% as cutoff value) Uncontrolled cardiovascular disease Poor overall health (ASA IV)

Ages Eligible for Study
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Minimum Age: 20 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Immediate implant placement without reconstruction<br>Immediate implant placement after tooth extraction | Procedure: implant placement<br>* autogenous bone reconstruction of damaged socket & simultaneous implant placement<br>* Other names: bone reconstruction;|
| Other: Immediate implant placement with reconstruction<br>Immediate implant placement and simultaneous bone reconstruction after tooth extraction | Procedure: implant placement<br>* autogenous bone reconstruction of damaged socket & simultaneous implant placement<br>* Other names: bone reconstruction;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate implant placement feasibility & success rate at 12 months | evaluate implant success following Karoussis et al. success criteria | 12 months | 
| Number of individuals with low pink esthetic outcomes as assessed by pink esthetic scores (PES) | pink esthetics scores (PES) as proposed by Belser et al. Values 0-10 were 10 is the best esthetic outcome. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant transparency: clinical presence or absence | Visual evaluation of facial mucosal implant transparency at 12 months: positive or negative | 12 months | 
| Number of participants with >0.2mm of marginal bone levels | evaluate radiographic marginal bone levels at 12 months with >0.2mm of bone loss | 12 months | 
| Band of keratinized tissue: clinical presence or absence | evaluate the presence of facial keratinized tissue on the implant sites >2 or <2mm | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dental implant, immediate dental implant, bone regeneration, peri-implantitis