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NCT05485194 | NOT YET RECRUITING | Alveolar Bone Resorption

Ridge Preservation Following Tooth Extraction
Sponsor:

University of Maryland, Baltimore

Information provided by (Responsible Party):

See-Lim Oh

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

Alveolar Bone Resorption

Tooth Extraction

Intervention/treatment

Reducing dimensional changes following tooth extraction

Phase

NA

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
Estimated Enrollment : 150 participants
Masking : SINGLE
Primary Purpose : TREATMENT
Official Title : Use of a Titanium Bone Screw for Ridge Preservation Following Tooth Extraction
Actual Study Start Date : 2025-12-01
Estimated Primary Completion Date : 2027-03-31
Estimated Study Completion Date : 2028-03-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
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.
Ridge Preservation Following Tooth Extraction

Location Details

NCT05485194

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Locations

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