Using Fascia Lata Membrane Versus Connective Tissue Graft in Immediate Implants

Study Overview
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Brief Summary
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The aim of this study is to evaluate and compare the Vestibular Socket Therapy (VST) technique using fascia lata membrane versus connective tissue graft both with xenogenic lamina membrane in immediate implants of anterior aesthetic zone.

Official Title
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Vestibular Socket Therapy Using Fascia Lata Membrane Versus Connective Tissue Graft in Immediate Implants of Aesthetic Zone

Conditions
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Connective Tissue Graft, Anterior Aesthetic Zone

Intervention / Treatment
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* Procedure: Test
* Procedure: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Class II socket according to Elian et al, described as facial soft tissue is present but the buccal plate is partially missing following extraction of the tooth in the maxillary anterior region. Thin gingival phenotype. Bone quality ranges from D2-D3 as gained from preoperative cone-beam computed tomography. Presence of at least 3 mm of keratinized gingiva. Optimal compliance as evidenced by no missing treatment appointments and a positive attitude towards oral hygiene Exclusion Criteria: Medically compromised patients and systemic conditions precluding implant and periodontal surgery. Smokers, diabetics, pregnant or lactating women. History of chemotherapy, radiotherapy in head and/or neck region. Bisphosphonate therapy.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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 |
| --- | --- |
| Experimental: Fascia lata membrane<br> | Procedure: Test<br>* immediate implant and VST with fascia lata membrane + xenogenic lamina membrane and particulate bone graft composed of autogenous cortical chips harvested from the surgical site<br>|
| Active Comparator: Connective tissue graft both with xenogenic lamina membrane<br> | Procedure: Control<br>* immediate implant and VST with connective tissue graft + xenogenic lamina membrane and particulate bone graft composed of autogenous cortical chips harvested from the surgical site<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in peri-implant mucosal level | The changes in peri-implant mucosal level will be assessed by superimposition of scanning files of different intervals to monitor the changes in surface area calculated by software. | at baseline, 6 months and 12 months | 
| Changes in gingival phenotype | The changes in gingival phenotype could be assessed at 6 months and 12 months intervals by superimposition of DICOM files on CBCT software. | at baseline, 6 months and 12 months | 
| Chaneg in height of labial (facial) plate of bone | Cone beam computed tomography (CBCT) | at baseline, 6 months and 12 months | 
| Chaneg in thickness of labial (facial) plate of bone | Cone beam computed tomography (CBCT) | at baseline, 6 months and 12 months |