Temporary Anchorage Devices for Ridge Preservation

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.

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Key information

Conditions

Ridge Preservation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Maryland School of Dentistry

Baltimore, Maryland, 21201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mini-screw

Device

Placement of a mini-screw

Primary outcomes

Changes in Width of Extraction Site (Ridge)

Time frame: 8 months

the distance from the buccal plate to the palatal plate

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Registry information

Official study title

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

Acronym: TAD

Important dates

Study start: 2018
Primary completion: 2020
Study completion: 2020
First posted: Jul 2, 2017
Registry last updated: Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed