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Trial record 10 of 3324 for:    Louisville

Ridge Preservation Comparing the Healing With or Without a Barrier Membrane

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ClinicalTrials.gov Identifier: NCT02798887
Recruitment Status : Not yet recruiting
First Posted : June 14, 2016
Last Update Posted : January 3, 2018
Sponsor:
Information provided by (Responsible Party):
Henry Greenwell, University of Louisville

Brief Summary:
Ridge Preservation Comparing the Clinical and Histologic Healing of Membrane vs. no Membrane Approach to Grafting.

Condition or disease Intervention/treatment Phase
Jaw, Edentulous, Partially Procedure: Ridge preservation Not Applicable

Detailed Description:
Thirty patients will be treated using the principles of bone grafting for ridge preservation. Fifteen test patients will receive a flap technique with an intrasocket cancellous cortical particulate allograft plus a facial overlay graft using a bovine xenograft without a membrane where only the exposed intrasocket allograft will be covered with a piece of Alloderm GBR. The positive control group of fifteen patients will receive a flap technique with an intrasocket cancellous cortical particulate allograft plus a facial overlay graft using a bovine xenograft plus Alloderm GBR membrane. Approximately, four months post-surgery, a trephine core will be taken from the grafted site immediately prior to implant placement and submitted for histologic processing.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ridge Preservation Comparing the Clinical and Histologic Healing of Membrane vs. no Membrane Approach to Grafting.
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Arm Intervention/treatment
Experimental: Ridge preservation membrane
Positive control Patients will receive ridge preservation intrasocket allograft and overlay xenograft resorbable with membrane
Procedure: Ridge preservation
Ridge preservation comparing the clinical and histologic healing with or without a barrier membrane
Experimental: Ridge preservation no membrane
test patients will receive ridge preservation intrasocket allograft and overlay xenograft with no membrane
Procedure: Ridge preservation
Ridge preservation comparing the clinical and histologic healing with or without a barrier membrane



Primary Outcome Measures :
  1. Change in post-extraction site to 4 month change in crestal osseous width [ Time Frame: 4 months ]
    Changes in post-extraction to 4 month change in ridge measurements at the mid defect alveolar crest and 5 mm apical taken with a caliper.


Secondary Outcome Measures :
  1. Change in Soft tissue thickness [ Time Frame: 4 months ]
    Soft tissue thickness measurements taken with a #40 endodontic reamer.

  2. Percent osseous tissue [ Time Frame: 4 months ]
    A trephine core will be harvested at 4 months. Following histologic processing the osseous core will be classified into percent vital bone, nonvital bone and trabecular space.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Have one non-molar tooth requiring extraction that will be replaced by a dental implant. The site must be bordered by at least one tooth.
  2. Healthy male or female who is at least 18 years old.
  3. Patients must sign an informed consent approved by the University of Louisville Human Studies Committee.

Exclusion Criteria:

  1. Patients with debilitating systemic diseases, or diseases that have a clinically significant effect on the periodontium.
  2. Presence or history of osteonecrosis of jaws.
  3. Patients who are currently taking IV bisphosphonates or who had IV treatment with bisphosphonates irrespective of duration.
  4. Patients who have been treated with oral bisphosphonates for more than three years.
  5. Patients with an allergy to any material or medication used in the study.
  6. Patients who need prophylactic antibiotics
  7. Previous head and neck radiation therapy.
  8. Chemotherapy in the previous 12 months.
  9. Patients on long term NSAID or steroid therapy.
  10. Pregnant patients.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02798887


Contacts
Contact: Henry Greenwell, DMD, MSD 502-852-1213 henry.greenwell@louisville.edu
Contact: Abdullah Alkanan, BDS 202-320-6452 abdullah.alkanan@louisville.edu

Locations
United States, Kentucky
Graduate Periodontics Clinic University of Louisville
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
University of Louisville
Investigators
Principal Investigator: Henry Greenwell, DMD, MSD University of Louisville

Responsible Party: Henry Greenwell, Professor, University of Louisville
ClinicalTrials.gov Identifier: NCT02798887     History of Changes
Other Study ID Numbers: 16.0461
First Posted: June 14, 2016    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Henry Greenwell, University of Louisville:
Regeneration
Bone regeneration
Grafting, Bone
Allograft
Xenograft

Additional relevant MeSH terms:
Jaw, Edentulous
Jaw, Edentulous, Partially
Jaw Diseases
Musculoskeletal Diseases
Stomatognathic Diseases
Mouth, Edentulous
Mouth Diseases
Tooth Diseases