Ridge Preservation Following Tooth Extraction
Primary Purpose
Alveolar Bone Resorption, Tooth Extraction
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Reducing dimensional changes following tooth extraction
Sponsored by
About this trial
This is an interventional treatment trial for Alveolar Bone Resorption
Eligibility Criteria
Inclusion Criteria:
- age ≥18 years
- a tooth, which is in the area from the central incisor to the second premolar bounded by teeth (or implants) mesiodistally
- a tooth requiring extraction
Exclusion Criteria:
- thyroid dysfunctions
- diabetes mellitus
- history of a chronic use of corticosteroids (>6 months)
- history of oral/intravenous bisphosphonates within the past 2 years
- smoking
- history of other systemic conditions that could affect bone integrity.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Active Comparator
Arm Label
Unassisted healing
Titanium bone screw (TBS)
Alveolar ridge preservation (ARP)
Arm Description
The extraction sockets in the non-intervention group will be filled with blood clots only.
One titanium bone screw (TBS) will be placed over the labial/buccal plate of the extraction socket in the TBS group on the same day of the extraction.
The extraction socket will be filled with mineralized ground cortical allograft up to the level of the buccal and lingual/palatal bony plates. A resorbable membrane will be trimmed and adapted to cover the grafting material. The flaps will be secured with a monofilament suture.
Outcomes
Primary Outcome Measures
The width of the alveolar bone
Dimensional changes in the width of the alveolar bone following tooth extraction
Secondary Outcome Measures
Full Information
NCT ID
NCT05485194
First Posted
July 31, 2022
Last Updated
September 18, 2023
Sponsor
University of Maryland, Baltimore
1. Study Identification
Unique Protocol Identification Number
NCT05485194
Brief Title
Ridge Preservation Following Tooth Extraction
Official Title
Use of a Titanium Bone Screw for Ridge Preservation Following Tooth Extraction
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
March 31, 2027 (Anticipated)
Study Completion Date
March 31, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
An animal study and our pilot human study demonstrated that placing a smooth-surface titanium bone screw (TBS) over the buccal plate of an extraction socket resulted in less dimensional changes of the alveolar ridge along with no adverse effects. The purpose of this randomized clinical trial is to investigate the effectiveness of TBS application for ridge preservation in comparison to (1) unassisted/non-interventional socket healing and (2) alveolar ridge preservation (ARP) approach using allografts and a membrane.
Detailed Description
The participants will be randomized to one of the three groups: the non-intervention, titanium bone screw (TBS), and alveolar ridge preservation (ARP) groups. The sockets in the non-intervention group will be filled with blood clots only. One TBS will be placed over the labial/buccal plate of the extraction socket in the TBS group on the same day of the extraction. Allograft and resorbable collagen membrane will be used for the ARP group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alveolar Bone Resorption, Tooth Extraction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Unassisted healing
Arm Type
No Intervention
Arm Description
The extraction sockets in the non-intervention group will be filled with blood clots only.
Arm Title
Titanium bone screw (TBS)
Arm Type
Experimental
Arm Description
One titanium bone screw (TBS) will be placed over the labial/buccal plate of the extraction socket in the TBS group on the same day of the extraction.
Arm Title
Alveolar ridge preservation (ARP)
Arm Type
Active Comparator
Arm Description
The extraction socket will be filled with mineralized ground cortical allograft up to the level of the buccal and lingual/palatal bony plates. A resorbable membrane will be trimmed and adapted to cover the grafting material. The flaps will be secured with a monofilament suture.
Intervention Type
Other
Intervention Name(s)
Reducing dimensional changes following tooth extraction
Intervention Description
Use of a titanium bone screw for ridge preservation following tooth extraction
Primary Outcome Measure Information:
Title
The width of the alveolar bone
Description
Dimensional changes in the width of the alveolar bone following tooth extraction
Time Frame
up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
age ≥18 years
a tooth, which is in the area from the central incisor to the second premolar bounded by teeth (or implants) mesiodistally
a tooth requiring extraction
Exclusion Criteria:
thyroid dysfunctions
diabetes mellitus
history of a chronic use of corticosteroids (>6 months)
history of oral/intravenous bisphosphonates within the past 2 years
smoking
history of other systemic conditions that could affect bone integrity.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Se-Lim Oh
Phone
4107063708
Email
soh@umaryland.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Se-Lim Oh
Organizational Affiliation
University of Maryland School of Dentistry
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will not be shares with other researchers.
Citations:
PubMed Identifier
34741321
Citation
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. Erratum In: Clin Oral Implants Res. 2022 Sep;33(9):965.
Results Reference
result
PubMed Identifier
25403977
Citation
Melsen B, Huja SS, Chien HH, Dalstra M. Alveolar bone preservation subsequent to miniscrew implant placement in a canine model. Orthod Craniofac Res. 2015 May;18(2):77-85. doi: 10.1111/ocr.12058. Epub 2014 Nov 18.
Results Reference
result
Learn more about this trial
Ridge Preservation Following Tooth Extraction
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