Buccal Bone Resorption in Immediate SLActive Implant Placement Thin vs. Thick Buccal Bone

Study Overview
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Brief Summary
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The utilization of SLActive implants which allow more rapid osseointgeration with 3 to 4 weeks. will be placed in thin buccal bone as immediate implants to determine the resorption compared to thick buccal bone

Detailed Description
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With the increased demand for aesthetics and the expectation of immediate tooth replacement, improving the treatment options in case with hopeless teeth in the esthetic zone by immediate implants is a need by both practitioners and patients. Current guidelines, today, restricting such treatment to only thick (+ or = 1mm) buccal bone plates. However, the literature shows that less than 10% of the community have such criteria, making it a high risk but needed procedure. Soft tissue and bone remodelling after extraction is an inescapable fact. Immediate implant placement cannot prevent soft tissue and bone remodeling around implants (Araújo et al. 2005, Chen et al. 2009), but implant surface treatment and modifications might enhance the maintainability of the supporting structures around the dental implant due to its faster integration, better stimulating the vascular components at the site. This could be tested by the crestal and buccal bone changes, pink esthetic score and ostell readings.

Official Title
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Evaluation of the Buccal Bone Resorption in Immediate SLActive Implant Placement in Thin vs. Thick Buccal Bone Plates: RCT

Conditions
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Dental Implant, Immediate Implant

Intervention / Treatment
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* Device: immediate implant placement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Single bounded irrestorable tooth in the esthetic zone that needs to be extracted. Healthy systemic condition. Type I socket with a minimum of 1mm of buccal bone thickness prior to extraction. (Morton et al., 2014) Sufficient bone apical to the socket for implant primary stability. (Morton et al., 2014) Good oral hygiene. Patient accepts a minimum of three-year follow-up period (cooperative patients). Exclusion Criteria: Signs of acute infection related to the area of interest. Patients with parafunctional habits (Lobbezoo et al. 2006 and Roelhing et al. 2016). Smokers (Lambert et al. 2000). Pregnant females.

Ages Eligible for Study
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Minimum Age: 20 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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: thin buccal bone<br> | Device: immediate implant placement<br>* Minimally traumatic tooth extraction, immediate implant placement and hard tissue grafting. loading after 3 months.<br>|
| Active Comparator: thick buccal bone<br> | Device: immediate implant placement<br>* Minimally traumatic tooth extraction, immediate implant placement and hard tissue grafting. loading after 3 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bucccal bone changes | standardized Cone beam computed Tomography The radiograph will be taken preoperatively and 12 month after. The pre and post operative cone beams will be compared to each other observing any changes of the buccal bone at 2 , 4 and 6 mm from the crest, the measurements will be in mm | 12 months post loading | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant stability | Ostell readings in isq (range from 55 till over 70) bleow 55 low stability over 55 till 65 moderate stability above 70 good stability | 3 months | 
| Crestal bone changes | Periapical radiograph the measurements will be taken from the platform of the implants. 3 readings will be taken one at the paltform one above and one below according to pattern and form of the resorption. | 12 months post loading | 
| Soft tissue thickness | Periodontal probe | 3 months | 
| Post operative pain and swelling | Blinded assessment ( numerical score) | 1 week | 
| Buccal bone thickness | Cone Beam Computed Topography | 3 months | 
| Postsurgical satisfaction | Questionnaire | 1 week | 
| Pink aesthetic score | Pink esthetic score Scale 0 being the lowest and 14 highest attainable | 12 months post loading | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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immediate implant, esthetic zone, buccal plate, SLActive