Temporary Anchorage Devices for Ridge Preservation

NCT03205800 | Completed Results FDA Device

• 1 other identifier: HP-00076020
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

Alveolar bone is a bony portion surrounding the root of a tooth. The alveolar bone disappears gradually when the tooth is extracted. This bone loss often becomes a problem if a patient wants to close the missing tooth space with orthodontic treatments (braces), or to get a dental implant (a metal post replacing a tooth). Therefore, we would like to place small screws at the extraction sites to preserve the alveolar bone when the teeth need to be extracted and a patient cannot start treatments some time. Mini-screws (small metal screws) are routinely used for regular orthodontic treatment. We will recruit patients who require extractions of two upper small molars (maxillary premolars) on both right and left sides. We will place one mini-screw on one side while the other side will be untouched after teeth extractions. Both sides will be followed at 8 months for examinations.

Conditions

Ridge Preservation

Outcome Measures

Primary Outcomes (1)

• Changes in Width of Extraction Site (Ridge)

  the distance from the buccal plate to the palatal plate

  8 months

Study Arms (2)

Mini-screw placement

EXPERIMENTAL

One mini-screw (8 mm length) will be placed at the buccal plate of the extraction socket one week after the atraumatic extraction of maxillary first or second premolars in one side.

Device: Mini-screw

No treatment

NO INTERVENTION

No treatment will be conducted on the contralateral side.

Interventions

Mini-screw DEVICE

Placement of a mini-screw

Mini-screw placement

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
• two maxillary premolars (left and right) required to be extracted based on recommended dental treatment plans

You may not qualify if:

• uncontrolled hypertension
• diabetes mellitus
• subjects with a history of a long-term use of corticosteroid (\> 6 months)
• subjects with a history of taking oral/IV bisphosphonates within the past 2 years
• smokers

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland School of Dentistry

Baltimore, Maryland, 21201, United States

Location

Related Publications (1)

• 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 DERIVED

Results Point of Contact

• Title: Se-Lim Oh
• Organization: University of Maryland, Baltimore

soh@umaryland.edu

4107063708

Study Officials

• Se-Lim Oh

  University of Maryland School of Dentistry

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Model Details: a split-mouth design

Study Record Dates

• First Submitted: June 29, 2017
• First Posted: July 2, 2017
• Study Start: January 12, 2018
• Primary Completion: November 9, 2020
• Study Completion: November 9, 2020
• Last Updated: February 19, 2025
• Results First Posted: February 19, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)