Temporary Anchorage Devices for Ridge Preservation

Ridge Preservation Clinical Trial

— TAD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03205800
• Other study ID #: HP-00076020
• Status: Completed
• Phase: N/A
• Start date: October 26, 2017
• Est. completion date: November 9, 2020

Study information

• Verified date: November 2020
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 4 months and 8 months for examinations.

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 4 months and 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: November 9, 2020
• Est. primary completion date: November 9, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ridge Preservation

Intervention

Other:
• Mini-screw
Placement of a mini-screw

Locations

Country	Name	City	State
United States	University of Maryland School of Dentistry	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in ridge width	the distance from the buccal plate to the palatal plate	at baseline, 4 months, and 8 months