Ridge Preservation Following Tooth Extraction

Study Overview
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Brief Summary
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An animal study and our pilot human study demonstrated that placing a smooth-surface titanium bone screw (TBS) over the buccal plate of an extraction socket resulted in less dimensional changes of the alveolar ridge along with no adverse effects. The purpose of this randomized clinical trial is to investigate the effectiveness of TBS application for ridge preservation in comparison to (1) unassisted/non-interventional socket healing and (2) alveolar ridge preservation (ARP) approach using allografts and a membrane.

Detailed Description
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The participants will be randomized to one of the three groups: the non-intervention, titanium bone screw (TBS), and alveolar ridge preservation (ARP) groups. The sockets in the non-intervention group will be filled with blood clots only. One TBS will be placed over the labial/buccal plate of the extraction socket in the TBS group on the same day of the extraction. Allograft and resorbable collagen membrane will be used for the ARP group.

Official Title
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Use of a Titanium Bone Screw for Ridge Preservation Following Tooth Extraction

Conditions
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Alveolar Bone Resorption, Tooth Extraction

Intervention / Treatment
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* Other: Reducing dimensional changes following tooth extraction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age ≥18 years a tooth, which is in the area from the central incisor to the second premolar bounded by teeth (or implants) mesiodistally a tooth requiring extraction Exclusion Criteria: thyroid dysfunctions diabetes mellitus history of a chronic use of corticosteroids (>6 months) history of oral/intravenous bisphosphonates within the past 2 years smoking history of other systemic conditions that could affect bone integrity.

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: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Unassisted healing<br>The extraction sockets in the non-intervention group will be filled with blood clots only. | |
| Experimental: Titanium bone screw (TBS)<br>One titanium bone screw (TBS) will be placed over the labial/buccal plate of the extraction socket in the TBS group on the same day of the extraction. | Other: Reducing dimensional changes following tooth extraction<br>* Use of a titanium bone screw for ridge preservation following tooth extraction<br>|
| Active Comparator: Alveolar ridge preservation (ARP)<br>The extraction socket will be filled with mineralized ground cortical allograft up to the level of the buccal and lingual/palatal bony plates. A resorbable membrane will be trimmed and adapted to cover the grafting material. The flaps will be secured with a monofilament suture. | Other: Reducing dimensional changes following tooth extraction<br>* Use of a titanium bone screw for ridge preservation following tooth extraction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The width of the alveolar bone | Dimensional changes in the width of the alveolar bone following tooth extraction | up to 6 months |