Alveolar Ridge Preservation With Layered Collagen and Xenograft

Study Overview
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Brief Summary
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alveolar ridge preservation using deep collagen layer, xenograft and collagen membrane seal versus the use of xenograft and collagen membrane seal alone. Measuring the clinical and radiographic alveolar ridge dimensional changes following after preservation at the time of implant placement

Detailed Description
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alveolar ridge preservation using deep collagen layer, xenograft and collagen membrane seal versus the use of xenograft and collagen membrane seal alone. The primary objective of the study is measuring the clinical and radiographic alveolar ridge dimensional changes following the procedure 4 months post operatively The secondary objective : Histological assessment of alveolar bone specimens to assess bone remodeling and new bone formation in both studied groups after four months. Patient satisfaction after implant placement

Official Title
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Biologically Oriented Alveolar Ridge Preservation With Layered Collagen and Xenograft (A Randomized Controlled Clinical Trial With Histological Evaluation)

Conditions
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Alveolar Ridge Preservation

Intervention / Treatment
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* Procedure: deep collagen layer, xenograft and collagen membrane
* Procedure: xenograft and collagen membrane


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Systemically healthy patients (American Society of Anesthesiologists I; ASA I). Patients diagnosed with single unrestorable molar teeth (socket type I) requiring extraction and implant placement (Elian et al.2007). Teeth free from any infection or periapical pathosis. Enough zone of keratinized tissue with at least 2mm. Good compliance with the plaque control instructions following initial therapy. Availability for follow up and maintenance program. Exclusion Criteria: Bad oral hygiene. Presence of smoking habit. Presence of occlusal interferences Pregnant females Vulnerable group of patients (handicapped, mentally retarded and prisoners) (according to the recommendation of esthetical committee of Faculty of Dentistry Ain Shams University).

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 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
Interventional Model Description: The application of deep collagen layer, xenograft and collagen membrane seal versus the use of xenograft and collagen membrane seal alone in alveolar ridge preservation procedures.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: deep collagen layer, xenograft and collagen membrane<br>Alveolar ridge preservation is done using deep collagen layer, xenograft and collagen membrane | Procedure: deep collagen layer, xenograft and collagen membrane<br>* Alveolar ridge preservation is done using deep collagen layer, xenograft and collagen membrane<br>|
| Active Comparator: xenograft and collagen membrane<br>Alveolar ridge preservation is done using xenograft and collagen membrane alone | Procedure: xenograft and collagen membrane<br>* Alveolar ridge preservation is done using xenograft and collagen membrane only<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measuring the clinical alveolar ridge changes | Measuring the thickness of the alveolar ridge in mm | at baseline and 4 months | 
| Measuring the radiographic change in the buccal bone thickness | Measuring the change in the thickness of the buccal ridge radiographically in mm | at baseline and 4 months | 
| Measuring the radiographic alveolar ridge dimensional changes | Measuring the bone density in hounsfield units (HU) | at baseline and 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histological assessment of core biopsy | The microscopic examination of the bone remodeling and new bone through tissue biopsy (fixation and staining of the tissues) to examine the newly formed cells and count them to determine the amount of newly tissue formed | 4 months post operatively |