Ridge Preservation Following Tooth Extraction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2028-03-31

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.

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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.

Conditions

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Alveolar Bone Resorption Tooth Extraction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Unassisted healing

The extraction sockets in the non-intervention group will be filled with blood clots only.

Group Type NO_INTERVENTION

No interventions assigned to this group

Titanium bone screw (TBS)

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.

Group Type EXPERIMENTAL

Reducing dimensional changes following tooth extraction

Intervention Type OTHER

Use of a titanium bone screw for ridge preservation following tooth extraction

Alveolar ridge preservation (ARP)

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.

Group Type ACTIVE_COMPARATOR

Reducing dimensional changes following tooth extraction

Intervention Type OTHER

Use of a titanium bone screw for ridge preservation following tooth extraction

Interventions

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Reducing dimensional changes following tooth extraction

Use of a titanium bone screw for ridge preservation following tooth extraction

Intervention Type OTHER

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes