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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03205800
Other study ID # HP-00076020
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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