Guided Bone Regeneration for Horizontal Alveolar Ridge Augmentation With Double Layer Technique

Study Overview
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Brief Summary
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clinical study with guided bone regeneration for deficient alveolar ridge to restore the defect in width and be able to place implant with two different technique

Detailed Description
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This study will be conducted to compare the bone formation with double layer graft technique versus standard protocol in GBR for horizontal ridge augmentation with staged implant placement Primary outcome: Evaluation of alveolar bone width gain clinically and radiographically. Secondary outcome: Histological analysis of remodeled bone.

Official Title
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Evaluation of Double Layer Graft Technique for Horizontal Ridge Augmentation With Staged Implant Placement (A Randomized Controlled Clinical Trial With Histological Assessment)

Conditions
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Guided Bone Regeneration

Intervention / Treatment
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* Procedure: Double layer technique


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1- Healthy adult patients as evidenced by Burkett's oral medicine health history questionnaire. (American Society of Anesthesiologists I; ASA I) (Mombelli and Cionca, 2006) 2- Both genders. 3- Age from 20 - 40 years old. 4- Having missing maxillary or mandibular tooth with low or moderate horizontal defect (4-8) according to cologne classification (2013) 5- Presence of sufficient bone height minimum 12 mm that does not require bone grafting or any other ridge augmentation procedure.(Shah and Lum, 2008) 6- Presence of sufficient keratinized mucosa of at least 2 mm.(Bassetti, et al. 2015) Exclusion Criteria: 1- Smokers (Twito and Sade, 2014) 2- Vulnerable groups (as pregnant females and decisional impaired individuals) will be excluded from the study. 3- Patients with poor oral hygiene or not willing to perform oral hygiene measures. 4- Prisoners and handicapped patients. 5- Patients with periodontal or periapical infections.(Tonetti, et al. 1996)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 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: double layer technique<br>include 9 patients will receive lateral alveolar ridge augmentation with double bone graft layer technique for GBR (first layer autograft followed by xenograft second layer | Procedure: Double layer technique<br>* Double layer technique for alveolar ridge augmentation (first layer autograft followed by xenograft second layer).<br>|
| Other: control<br>include 9 patients will receive lateral alveolar ridge augmentation with stander protocol for GBR technique (mixture of autograft and xenograft | Procedure: Double layer technique<br>* Double layer technique for alveolar ridge augmentation (first layer autograft followed by xenograft second layer).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical and radiographic outcome | clinical ridge width gain | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| histological analysis of remodeled bone. | core biopsy were taken after 6 months from augmentation | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sausage technique