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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mini-screw placement | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mini-screw | Device | Placement of a mini-screw |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Width of Extraction Site (Ridge) | the distance from the buccal plate to the palatal plate | 8 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Se-Lim Oh | University of Maryland School of Dentistry | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland School of Dentistry | Baltimore | Maryland | 21201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34741321 | Derived | 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. |
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Individual patient data will not be shared. The results will be published.
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There was no significant event in this study that occur after participant enrollment and prior to assignment. One participant has both experimental (mini-screw placement) and control (no treatment) sides.
The study protocol was approved in October 2017 by the IRB. The recruitment period was from 1/12/2018 to 12/10/2018 at the University of Maryland Dental Clinics.
| ID | Title | Description |
|---|---|---|
| FG000 | 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. Mini-screw: Placement of a mini-screw |
| FG001 | No Treatment | No treatment will be conducted for extraction sockets on the contralateral side. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Each participant contributed 2 units.
| ID | Title | Description |
|---|---|---|
| BG000 | 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. Mini-screw: Placement of a mini-screw |
| BG001 | No Treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Changes in Width of Extraction Site (Ridge) | the distance from the buccal plate to the palatal plate | A total of six participants (four females and two males) completed this pilot study. Their mean age was 37 ± 21 years (range, 22-68). | Posted | Mean | Standard Deviation | mm | 8 months | Teeth | Teeth |
|
8 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Mini-screw: Placement of a mini-screw |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Inflammation at site | Infections and infestations | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Se-Lim Oh | University of Maryland, Baltimore | 4107063708 | soh@umaryland.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 17, 2019 | Dec 28, 2024 | Prot_SAP_001.pdf |
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a split-mouth design
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No treatment will be conducted for the extraction site on the contralateral side. |
| BG002 | Total | Total of all reporting groups |
| Teeth |
|
| years |
| Participants |
|
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
|
|
| Region of Enrollment | Count of Participants | Participants | Participants |
|
|
| Width of extraction site (ridge) | Mean | Standard Deviation | mm | Participants |
|
|
|
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
| EG001 | No Treatment | No treatment after tooth extraction | 0 | 3 | 0 | 3 | 0 | 3 |
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