Demineralized Whole-tooth vs Demineralized Particulate Dentin Grafts in Alveolar Ridge Preservation

Study Overview
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Brief Summary
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The aim of this trial is to compare whole-tooth vs particulate dentin for their effects in alveolar ridge preservation.

Detailed Description
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Extraction of the teeth is still one of the most commonly undertaken procedures in dental practices due to various reasons that render the teeth non-restorable. Following extraction, replacing the lost teeth with a prosthetic alternative that provides for both optimal esthetics and function can be challenging due to the inevitable events of socket healing that results in the reduction in alveolar bone height and width. To overcome these limitations and provide for adequate ridge volume, different bone preservation or augmentation techniques can be utilized with different clinical applications. Alveolar ridge preservation is a procedure that attempts to reduce bone dimensional changes that naturally take place following tooth extraction. To overcome this problem, various approaches using various grafting materials and/or covering membranes have been proposed with varied success. The extracted tooth is no longer considered as clinical waste, it has been explored as an appropriate source for autogenous graft substitute. This idea emerged due to the shared embryonic origin of bone and teeth as well as the similarities in chemical structure as dentin is composed of 30-35% organic part and 65-70% inorganic part in comparison to alveolar bone, with inorganic and organic parts of 35% and 65% respectively. Both whole-tooth and particulate forms has been utilized for alveolar ridge preservation or augmentation but the superiority of one form over the other is not yet clear.

Official Title
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Demineralized Whole-tooth vs Demineralized Particulate Dentin Grafts in Alveolar Ridge Preservation. a Randomized Controlled Trial.

Conditions
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Alveolar Bone Loss

Intervention / Treatment
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* Procedure: Alveolar ridge preservation using whole-tooth dentin graft
* Procedure: Alveolar ridge preservation using particulate dentin graft


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Non-restorable tooth indicated for extraction single-rooted teeth Patients at least 18 years or older Motivated patients, agree to sign informed consent and complete the follow-up period Exclusion Criteria: Pregnant females active infection at extraction site Smokers systemic conditions affecting healing (e.g. diabetes, medications as bisphosphonates...)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: Whole-tooth dentin graft<br>The extracted tooth will be prepared as whole-tooth dentin graft and inserted in the extraction socket. | Procedure: Alveolar ridge preservation using whole-tooth dentin graft<br>* Minimally-traumatic extraction of non-restorable teeth then grafting with whole-tooth dentin graft<br>|
| Active Comparator: Particulate dentin graft<br>The extracted tooth will be prepared as particulate dentin graft and inserted in the extraction socket. | Procedure: Alveolar ridge preservation using particulate dentin graft<br>* Minimally-traumatic extraction of non-restorable teeth then grafting with particulate dentin graft<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alveolar bone width change in mm | Alveolar bone linear width will be measured at baseline at final cone beam computed tomography (CBCT) scans. The change in bone width will be calculated as the subtraction of final width from baseline width and will be expressed in millimetres. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alveolar bone height change in mm | Alveolar bone linear height will be measured at baseline at final cone beam computed tomography (CBCT) scans. The change in bone height will be calculated as the subtraction of final height from baseline height and will be expressed in millimetres. | 6 months | 
| Histological assessment | Bone samples from at least one control and one intervention site will be taken during implant placement using a trephine bur. Samples will be examined for new bone formation (Yes/no) and inflammatory response (Yes/no). | 6 months |