Titanium Bone Screw

Sponsor

University of Maryland, Baltimore (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05485194

Collaborator

(none)

150

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Alveolar Bone Resorption Tooth Extraction	Other: Reducing dimensional changes following tooth extraction	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Mar 31, 2027

Anticipated Study Completion Date :

Mar 31, 2028

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

The width of the alveolar bone [up to 6 months]
Dimensional changes in the width of the alveolar bone following tooth extraction

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Maryland, Baltimore

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Se-Lim Oh, Clinical Associate Professor, University of Maryland, Baltimore

ClinicalTrials.gov Identifier:

NCT05485194

Other Study ID Numbers:

HP-00102697

First Posted:

Aug 3, 2022

Last Update Posted:

Aug 3, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Bone Resorption

Study Results

No Results Posted as of Aug 3, 2022