Immediate Implant Placement: a Clinical and Radiographic Study on Hard and Soft Tissues Retraction at One Year.

Study Overview
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Brief Summary
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This project consists of placing dental implants at extraction sites. Bone drilling and implant placement are performed using the flapless method with the use of a surgical guide allowing guided surgery. After implant placement, temporary teeth are immediately made and placed on the implants to guide the gingival contour. Bone and soft tissue retraction at the implanted sites are measured radiographically and digitally using surface scan superimposition over a 12-month period.

Official Title
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Immediate Implant Placement: a Clinical and Radiographic Study on Hard and Soft Tissues Retraction at One Year.

Conditions
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Guided Surgery, Immediate Implant Placement, Immediate Tamporization

Intervention / Treatment
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* Other: Immediate Implant Placement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Absence of systemic or osseous disease that may impair peri-implant healing Age ≥ 21 years Acceptable oral hygiene Presence of both adjacent teeth Absence of acute infection in the treated area Absence of periodontal pockets > 3mm at the concerned site Absence of pre-operative defect at the buccal bone wall (dehiscence or fenestration) Per-operative integrity of the osseous and gingival structures (during tooth extraction) Light or non-smoker (<10 cigarettes per day) Exclusion Criteria: Myocardial infarction within the past 6 months. Poorly controlled diabetes (HBA1c > 7.5%). Coagulation disorders. Radiotherapy to the head/neck area within the past two years. Present or past treatment with intravenous bisphosphonates. Immunocompromised patients. Psychological or psychiatric problems. Alcohol or drug abuse. Poor oral hygiene and motivation (full mouth plaque score > 30% and/or full mouth bleeding score > 20%). Uncontrolled periodontal disease.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 74 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate implant placement with buccal gap grafted with Allograft<br>Following tooth extraction immediate implant will be placed in the palatal bone and the buccal gap between the implant and the buccal bone will be grafted with Allograft | Other: Immediate Implant Placement<br>* Tooth extraction followed by immediate implant placement. One group will have Allograft graft in the buccal gap, the other will have Xenograft graft.<br>|
| Experimental: Immediate implant placement with buccal gap grafted with Xenograft<br>Following tooth extraction immediate implant will be placed in the palatal bone and the buccal gap between the implant and the buccal bone will be grafted with Xenograft | Other: Immediate Implant Placement<br>* Tooth extraction followed by immediate implant placement. One group will have Allograft graft in the buccal gap, the other will have Xenograft graft.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hard tissue change by superimposing CBCT scans between 0 and 12 months using 3d slicer software | Buccal bone profil retraction after immediate implant placement using 2 different bone substitutes by comparing CBCT Dicom files at 0 and 12 months using 3d slicer software | 12 months | 
| Soft tissue change by superimposing surface intraoral scans between 0 and 12 months using 3d slicer software | Soft Tissue profil retraction after immediate implant placement using 2 different bone substitutes by superimposing STL files between 0 and 12 monts using 3d slicer software | 12 months |