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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
University of Maryland, Baltimore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alveolar Bone Resorption

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    July 31, 2022
    Last Updated
    September 18, 2023
    Sponsor
    University of Maryland, Baltimore
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    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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