Ridge Preservation
Conditions
Brief 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 8 months for examinations.
Detailed 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 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.
Interventions
DEVICEMini-screw
Placement of a mini-screw
Sponsors
University of Maryland, Baltimore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
a split-mouth design
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Width of Extraction Site (Ridge) | 8 months | the distance from the buccal plate to the palatal plate |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 3 |
| 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 | 6 |
| No Treatment No treatment will be conducted for the extraction site on the contralateral side. | 3 |
| No Treatment No treatment will be conducted for the extraction site on the contralateral side. | 6 |
| Total | 18 |
Baseline characteristics
| Characteristic | Mini-screw Placement | Total | No Treatment |
|---|---|---|---|
| Age, Continuous | 37 years STANDARD_DEVIATION 21 | 37 years STANDARD_DEVIATION 21 | 37 years STANDARD_DEVIATION 21 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 3 Participants | 6 Participants | 3 Participants |
| Sex: Female, Male Female | 2 Participants | 4 Participants | 2 Participants |
| Sex: Female, Male Male | 1 Participants | 2 Participants | 1 Participants |
| Width of extraction site (ridge) | 13.7 mm STANDARD_DEVIATION 1.2 | 13.36 mm STANDARD_DEVIATION 1.6 | 13 mm STANDARD_DEVIATION 1.96 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 3 |
| other Total, other adverse events | 0 / 3 | 0 / 3 |
| serious Total, serious adverse events | 0 / 3 | 0 / 3 |
Outcome results
Primary
Changes in Width of Extraction Site (Ridge)
the distance from the buccal plate to the palatal plate
Time frame: 8 months
Population: A total of six participants (four females and two males) completed this pilot study. Their mean age was 37 ± 21 years (range, 22-68).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mini-screw Placement | Changes in Width of Extraction Site (Ridge) | 0.7 mm | Standard Deviation 0.2 |
| No Treatment | Changes in Width of Extraction Site (Ridge) | 1.3 mm | Standard Deviation 0.7 |
p-value: <0.05Wilcoxon signed rank test