Ridge Preservation Following Tooth Extraction

University of Maryland Baltimore (UMB)

Status: Begins enrollment in 11 months

Conditions: Tooth Extraction; Alveolar Bone Resorption

Treatments: Other: Reducing dimensional changes following tooth extraction

Study type: Interventional

Funder types: Other

Identifiers

NCT05485194

HP-00102697

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

---

150 participants in 3 patient groups

Unassisted healing

No Intervention group

Description:

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

Titanium bone screw (TBS)

Experimental group

Description:

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.

Treatment:

Other: Reducing dimensional changes following tooth extraction

Alveolar ridge preservation (ARP)

Active Comparator group

Description:

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.

Treatment:

Other: Reducing dimensional changes following tooth extraction