Temporary Anchorage Devices for Ridge Preservation (TAD)

The Use of Temporary Anchorage Devices for Ridge Preservation After Tooth Extraction

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.

Study Overview

• Status: Completed
• Conditions: Ridge Preservation
• Intervention / Treatment: Device: Mini-screw

Detailed Description

The purpose of this study is to investigate the effects of transcortical mini-screws on ridge preservation following tooth extraction with a split mouth design. The study will evaluate clinical and radiographic outcomes following transcortical screw placements at extraction sites compared to non-treated extraction sites.

Specific Aim 1: To evaluate the clinical outcomes between the treated sites with a transcortical screw (the experimental group) and the non-treated sites (the control group) Null Hypothesis: There will be no differences in clinical parameters between the two groups.

Approach: The investigators will conduct a prospective split-mouth design clinical study. The investigators will compare the clinical changes in vertical bone height and horizontal bone width at 8 months from baseline (tooth extraction).

Specific Aim 2: To evaluate the radiographic outcome between the experimental group and the control group Null Hypothesis: There will be no difference in alveolar ridge height and width between the two groups.

Approach: The study will measure ridge height and width using cone beam computed tomography (CBCT) at baseline and 8 months.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland School of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• age ≥ 18 years
• two maxillary premolars (left and right) required to be extracted based on recommended dental treatment plans

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mini-screw placement; 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; Placement of a mini-screw
No Intervention: No treatment; No treatment will be conducted on the contralateral side.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Width of Extraction Site (Ridge)	the distance from the buccal plate to the palatal plate	8 months

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore
• Investigators: Study Chair: Se-Lim Oh, University of Maryland School of Dentistry

Publications and helpful links

General Publications

• 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 Implants Res. 2022 Sep;33(9):965. doi: 10.1111/clr.13987.

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2018
• Primary Completion (Actual): November 9, 2020
• Study Completion (Actual): November 9, 2020

Study Registration Dates

• First Submitted: June 29, 2017
• First Submitted That Met QC Criteria: June 29, 2017
• First Posted (Actual): July 2, 2017

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 28, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: HP-00076020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual patient data will not be shared. The results will be published.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes