Comparison of Peri-implant Tissues Using Socket Shield Technique Versus Xenograft

Study Overview
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Brief Summary
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The aim of this study is to clinically and radiographically evaluate the dimensional changes of soft and hard peri-implant tissues around single immediate post-extraction implants in the esthetic zone.

Detailed Description
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to compare the efficacy of the socket shield technique in counteracting the dimensional changes of the soft and hard peri-implant tissues to filliing the buccal gap with xenograft. Population (P): Patients with single non-restorable tooth in the esthetic zone. Intervention (I): Immediate implant placement with socket shield technique. Comparator (C): Immediate implant placement and filling the buccal gap with xenograft. Primary Outcome (O): Pink Esthetic Score (PES) (Fürhauser et al., 2005). Time frame: 9 months (Chu et al., 2015). Study design: Randomized controlled clinical trial.

Official Title
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Comparison of the Dimensional Changes of Hard and Soft Peri-implant Tissues Around Single Immediate Post-Extraction Implants in the Esthetic Zone With Socket Shield Technique Versus Using Xenograft: A Randomized Controlled Clinical Trial

Conditions
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Socket Shield

Intervention / Treatment
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* Procedure: socket shield technique
* Procedure: xenograft


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient's age was 18 years or older. Non-restorable tooth in the upper inter-bicuspid area. Adequate bone volume for the placement of immediate implant. Following tooth extraction, there was an intact socket bony wall (type I extraction socket). Primary stability of the implant was achieved at the time of the implant placement. Exclusion Criteria: Patients who reported tobacco use in the past 5 years. Patients who had severe periodontal destruction at the site of implant placement. The presence of any signs of acute infection in the surgical site or the adjacent two natural teeth. Patients who had history of any systemic disease that precludes the placement of implants. Any disease that might affect bone metabolism as osteoporosis. Patients taking medications that might affect bone turn over as bisphosphonates. Physically or mentally handicapped patients. Pregnant females. Teeth with vertical root fractures on the buccal aspect Teeth with any other pathologies affecting the buccal part of the root, for example, external or internal resorptions.

Ages Eligible for Study
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Minimum Age: 18 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: experimental<br>immediate implant with socket shield technique | Procedure: socket shield technique<br>* immediate implant placement with buccal part of the root is retained<br>|
| Active Comparator: control<br>immediate implant placement with filling the buccal gap with xenograft | Procedure: xenograft<br>* immediate implant placement with filling the buccal gap with xenograft<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pink esthetic score | Pink esthetic score evaluates the soft tissue esthetics around implant supported crowns. Using a 0-1-2 scoring system, 0 being the lowest, 2 being the highest value. The maximum achievable PES is 14. 7 variables are measured: mesial and distal papillae being 0 if absent, 1 if incomplete and 2 if complete. Alveolar process, soft tissue level, contour, texture and color being 0 if major discrepancy, 1 if minor discrepancy and 2 if matches the contralateral | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recession of the buccal peri-implant mucosa | measured at the apical zenith of the mucosal margin on the implants after digital superimposition of the optically scanned models as the vertical distance change between the former and the new position of soft tissue margins. | 9 months | 
| Corono-apical peri-implant bone dimensional changes | measured at the middle of the buccal implant surface after the superimposition of Cone Beam C.T scans as the difference between the former and new vertical distance from the implant platform to the buccal alveolar crest | 6 months | 
| Bucco-lingual peri-implant bone dimensional changes | measured at middle of the buccal implant surface 1mm below the alveolar crest after the superimposition of the Cone Beam C.T scans as the difference between the former and new horizontal distance between the buccal and the palatal plate of bone | 6 months | 
| Patient satisfaction: VAS | Patient satisfaction will be evaluated using a questionnaire which is based on a visual analog scale (VAS). A horizontal VAS bar, 100 mm long, with the right anchor labeled much less than natural teeth which is marked by zero and the left anchor labeled much more which is marked by 10 will be used. Five questions will be formulated to record the patients' satisfaction in terms of functionality and from an esthetic point of view. Participants will look in a mirror and also be viewed a photograph before recording their answers on the horizontal calibrated line. | 9 months |