Ignite Creation Date:
2024-05-06 @ 10:15 AM
Last Modification Date:
2024-10-26 @ 12:27 PM
Study NCT ID:
NCT03205800
Status:
COMPLETED
Last Update Posted:
2020-11-12
First Post:
2017-06-29
Brief Title:
Temporary Anchorage Devices for Ridge Preservation
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
The Use of Temporary Anchorage Devices for Ridge Preservation After Tooth Extraction
Status:
COMPLETED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TAD
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 4 months and 8 months for examinations
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
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 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None