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Evaluation of Healing at Molar Extraction Sites With and Without Ridge Preservation

Primary Purpose

Loss of Teeth Due to Extraction

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ridge preservation
Sponsored by
The University of Texas Health Science Center at San Antonio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Loss of Teeth Due to Extraction

Eligibility Criteria

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

Inclusion Criteria:

  • Patients will be included in this study if they qualify the following inclusion criteria:

    • One molar tooth that has been identified by dental faculty as requiring a single tooth extraction
    • A dental implant is indicated and treatment planned to replace the missing molar tooth
    • Have adequate restorative space for a dental implant-retained restoration
    • Have at least 10mm of alveolar bone height, without impinging on the maxillary sinus or inferior alveolar canal.

Exclusion Criteria:

  • Obvious exclusions are patients who do not meet all the inclusion criteria or who will not cooperate with the follow-up schedule.
  • Patients will not be entered who are mentally incompetent, prisoners, or pregnant.
  • Pregnant women or women intending to become pregnant during the study period. As standard practice prior to dental surgery, females of child-bearing age are asked verbally if there is any possibility that they are pregnant. If not, we proceed with surgery and no pregnancy test is done. If the woman states that there is a possibility that she is pregnant, we do a urine pregnancy test to rule pregnancy in or out. So use of the urine pregnancy test is only done if she says she may be pregnant. [If needed: An over-the-counter urine pregnancy test will be provided to female subjects in the graduate periodontics clinic of UTHSCSA. Patients will be allowed access to a private restroom and the results of the tests will be read by one of the named investigators. Only those with a negative pre-operative pregnancy test will be eligible for the study.] Female patients who have undergone a hysterectomy, tubal ligation or menopause will be excluded from pregnancy testing.
  • Patients who become pregnant during the study will be withdrawn and standard care will be delivered.

  • Clinical and/or radiographic determinations which will preclude inclusion in this study are:

    • Active localized or systemic infection other than periodontitis.
    • Untreated periodontal diseases
    • Inadequate bone dimensions or restorative space dimensions to place a dental implant
    • Presence of a disease entity, medical condition or therapeutic regimen which decreases probability of soft tissue and bony healing, e.g., poorly controlled diabetes, chemotherapeutic and immunosuppressive agents, or autoimmune diseases.
    • Positive medical history of endocarditis following oral or dental surgery.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    Ridge preservation

    No ridge preservation

    Arm Description

    The molar extraction socket is grafted with FDA approved materials, which includes a bone graft material derived from human donors (enCore®, Osteogenics biomedical, Lubbock, TX) and a membrane (like a thin sheet of paper) covering the grafted extraction socket. The membrane used will need to be removed at a later point since it is non-resorbable (it will not "dissolve" by itself). This membrane is made of dense polytetrafluoroethylene (dPTFE) (Cytoplast™, Osteogenics biomedical, Lubbock, TX). The procedure is called "Ridge preservation"

    The molar extraction socket is left to heal by itself without any grafting material or membrane, i.e. "Spontaneous Healing" (No ridge preservation is performed)

    Outcomes

    Primary Outcome Measures

    Radiographic Bone Changes
    The width and the height of the alveolar ridge will be measured (in mm) on the initial (i.e. following tooth extraction) Cone Beam CT and on the CBCT taken prior to implant placement (i.e. 3 months after tooth extraction)

    Secondary Outcome Measures

    Full Information

    First Posted
    August 20, 2015
    Last Updated
    May 21, 2018
    Sponsor
    The University of Texas Health Science Center at San Antonio
    Collaborators
    Osteogenics Biomedical
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02543398
    Brief Title
    Evaluation of Healing at Molar Extraction Sites With and Without Ridge Preservation
    Official Title
    Evaluation of Healing at Molar Extraction Sites With and Without Ridge Preservation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2013 (undefined)
    Primary Completion Date
    May 2016 (Actual)
    Study Completion Date
    July 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The University of Texas Health Science Center at San Antonio
    Collaborators
    Osteogenics Biomedical

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Following tooth extraction ridge preservation procedure have been suggested to limit bone resorptive dimensional changes to facilitate prospective implant placement. While this is particularly true for anterior teeth, no evidence is available to establish clinical guidelines in posterior sites, i.e. following molar extraction. This research project will answer the following question: What are the dimensional changes of the hard and soft tissues encountered following molar extractions with and without ridge preservation?

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Loss of Teeth Due to Extraction

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    52 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Ridge preservation
    Arm Type
    Other
    Arm Description
    The molar extraction socket is grafted with FDA approved materials, which includes a bone graft material derived from human donors (enCore®, Osteogenics biomedical, Lubbock, TX) and a membrane (like a thin sheet of paper) covering the grafted extraction socket. The membrane used will need to be removed at a later point since it is non-resorbable (it will not "dissolve" by itself). This membrane is made of dense polytetrafluoroethylene (dPTFE) (Cytoplast™, Osteogenics biomedical, Lubbock, TX). The procedure is called "Ridge preservation"
    Arm Title
    No ridge preservation
    Arm Type
    Other
    Arm Description
    The molar extraction socket is left to heal by itself without any grafting material or membrane, i.e. "Spontaneous Healing" (No ridge preservation is performed)
    Intervention Type
    Procedure
    Intervention Name(s)
    Ridge preservation
    Intervention Description
    Ridge preservation is a procedure which consists in grafting the tooth extraction socket with a bone grafting material and cover the site with a membrane to protect the site.
    Primary Outcome Measure Information:
    Title
    Radiographic Bone Changes
    Description
    The width and the height of the alveolar ridge will be measured (in mm) on the initial (i.e. following tooth extraction) Cone Beam CT and on the CBCT taken prior to implant placement (i.e. 3 months after tooth extraction)
    Time Frame
    3 months after tooth extraction

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients will be included in this study if they qualify the following inclusion criteria: One molar tooth that has been identified by dental faculty as requiring a single tooth extraction A dental implant is indicated and treatment planned to replace the missing molar tooth Have adequate restorative space for a dental implant-retained restoration Have at least 10mm of alveolar bone height, without impinging on the maxillary sinus or inferior alveolar canal. Exclusion Criteria: Obvious exclusions are patients who do not meet all the inclusion criteria or who will not cooperate with the follow-up schedule. Patients will not be entered who are mentally incompetent, prisoners, or pregnant. Pregnant women or women intending to become pregnant during the study period. As standard practice prior to dental surgery, females of child-bearing age are asked verbally if there is any possibility that they are pregnant. If not, we proceed with surgery and no pregnancy test is done. If the woman states that there is a possibility that she is pregnant, we do a urine pregnancy test to rule pregnancy in or out. So use of the urine pregnancy test is only done if she says she may be pregnant. [If needed: An over-the-counter urine pregnancy test will be provided to female subjects in the graduate periodontics clinic of UTHSCSA. Patients will be allowed access to a private restroom and the results of the tests will be read by one of the named investigators. Only those with a negative pre-operative pregnancy test will be eligible for the study.] Female patients who have undergone a hysterectomy, tubal ligation or menopause will be excluded from pregnancy testing. Patients who become pregnant during the study will be withdrawn and standard care will be delivered. Clinical and/or radiographic determinations which will preclude inclusion in this study are: Active localized or systemic infection other than periodontitis. Untreated periodontal diseases Inadequate bone dimensions or restorative space dimensions to place a dental implant Presence of a disease entity, medical condition or therapeutic regimen which decreases probability of soft tissue and bony healing, e.g., poorly controlled diabetes, chemotherapeutic and immunosuppressive agents, or autoimmune diseases. Positive medical history of endocarditis following oral or dental surgery.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    27788625
    Citation
    Walker CJ, Prihoda TJ, Mealey BL, Lasho DJ, Noujeim M, Huynh-Ba G. Evaluation of Healing at Molar Extraction Sites With and Without Ridge Preservation: A Randomized Controlled Clinical Trial. J Periodontol. 2017 Mar;88(3):241-249. doi: 10.1902/jop.2016.160445. Epub 2016 Oct 27.
    Results Reference
    derived

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    Evaluation of Healing at Molar Extraction Sites With and Without Ridge Preservation

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