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NCT05485194 Clinical Trial

Ridge Preservation Following Tooth Extraction

Tooth Extraction Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05485194
Other study ID # HP-00102697
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date December 1, 2025
Est. completion date March 31, 2028

Study information
Verified date January 2024
Source University of Maryland, Baltimore
Contact Se-Lim Oh
Phone 4107063708
Email soh@umaryland.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 150
Est. completion date March 31, 2028
Est. primary completion date March 31, 2027
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• Reducing dimensional changes following tooth extraction
Use of a titanium bone screw for ridge preservation following tooth extraction

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University of Maryland, Baltimore

References & Publications (2)

Joseph S, Oh SL, Pae EK, Joshi S. Use of transcortical miniscrews for alveolar ridge preservation following tooth extraction: A pilot study. Clin Oral Implants Res. 2022 Feb;33(2):150-157. doi: 10.1111/clr.13875. Epub 2021 Nov 16. Erratum In: Clin Oral Im — View Citation

Melsen B, Huja SS, Chien HH, Dalstra M. Alveolar bone preservation subsequent to miniscrew implant placement in a canine model. Orthod Craniofac Res. 2015 May;18(2):77-85. doi: 10.1111/ocr.12058. Epub 2014 Nov 18. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary The width of the alveolar bone Dimensional changes in the width of the alveolar bone following tooth extraction up to 6 months
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