The Use of Temporary Anchorage Devices for Ridge Preservation After Tooth Extraction
| Registry | NCT03205800, acronym TAD |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 6 (Actual) |
| Sponsor | University of Maryland, Baltimore (Other) |
| Conditions | Ridge Preservation |
| Interventions | Mini-screw (Device) |
| Dates | start 2018-01-12, primary completion 2020-11-09, completion 2020-11-09, first posted 2017-07-02, last updated 2025-02-19 |
| Locations | 1 site in United States |
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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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Mini-screw placement | Experimental | Device: Mini-screw | 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. |
| No treatment | No intervention | No treatment will be conducted on the contralateral side. |
Sex: All, ages: 18 Years to any, accepts healthy volunteers
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
| Milestone | Mini-screw Placement | No Treatment |
|---|---|---|
| Started | 3 | 3 |
| Completed | 3 | 3 |
| Not completed | 0 | 0 |
Time frame: 8 months
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|---|---|---|
| Mini-screw Placement | 0/3 (0.0%) | 0/3 (0.0%) | 0/3 (0.0%) |
| No Treatment | 0/3 (0.0%) | 0/3 (0.0%) | 0/3 (0.0%) |
| Term | Organ system | Mini-screw Placement | No Treatment |
|---|---|---|---|
| Inflammation at site | Infections and infestations | 0/3 | 0/3 |
| Facility | City | Country | Status |
|---|---|---|---|
| University of Maryland School of Dentistry | Baltimore, Maryland | United States |