Ridge Preservation Following Tooth Extraction

January 16, 2024 updated by: Se-Lim Oh, University of Maryland, Baltimore

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Unassisted healing
The extraction sockets in the non-intervention group will be filled with blood clots only.
Experimental: 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.
Other: Reducing dimensional changes following tooth extraction
Use of a titanium bone screw for ridge preservation following tooth extraction
Active Comparator: 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.
Other: Reducing dimensional changes following tooth extraction
Use of a titanium bone screw for ridge preservation following tooth extraction

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Maryland, Baltimore

Investigators

  • Principal Investigator: Se-Lim Oh, University of Maryland School of Dentistry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2025

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2028

Study Registration Dates

First Submitted

July 31, 2022

First Submitted That Met QC Criteria

July 31, 2022

First Posted (Actual)

August 3, 2022

Study Record Updates

Last Update Posted (Estimated)

January 18, 2024

Last Update Submitted That Met QC Criteria

January 16, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HP-00102697

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shares with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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