Ridge Preservation Following Tooth Extraction

NCT05485194 | Withdrawn

• 1 other identifier: HP-00102697
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Alveolar Bone Resorption; Tooth Extraction

Outcome Measures

Primary Outcomes (1)

• The width of the alveolar bone

  Dimensional changes in the width of the alveolar bone following tooth extraction

  up to 6 months

Study Arms (3)

Unassisted healing

NO INTERVENTION

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

Titanium bone screw (TBS)

EXPERIMENTAL

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

Alveolar ridge preservation (ARP)

ACTIVE COMPARATOR

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

Interventions

Reducing dimensional changes following tooth extraction OTHER

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

Alveolar ridge preservation (ARP); Titanium bone screw (TBS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Related 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.

  PMID: 34741321 RESULT

• 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.

  PMID: 25403977 RESULT

Study Officials

• Se-Lim Oh

  University of Maryland School of Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: July 31, 2022
• First Posted: August 3, 2022
• Study Start: December 1, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: January 24, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share