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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):

June 9, 2016
June 14, 2016
January 3, 2018
July 2020
June 2021   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT02798887 on ClinicalTrials.gov Archive Site
  • Change in Soft tissue thickness [ Time Frame: 4 months ]
    Soft tissue thickness measurements taken with a #40 endodontic reamer.
  • 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.
Same as current
Not Provided
Not Provided
 
Ridge Preservation Comparing the Healing With or Without a Barrier Membrane
Ridge Preservation Comparing the Clinical and Histologic Healing of Membrane vs. no Membrane Approach to Grafting.
Ridge Preservation Comparing the Clinical and Histologic Healing of Membrane vs. no Membrane Approach to Grafting.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Jaw, Edentulous, Partially
Procedure: Ridge preservation
Ridge preservation comparing the clinical and histologic healing with or without a barrier membrane
  • Experimental: Ridge preservation membrane
    Positive control Patients will receive ridge preservation intrasocket allograft and overlay xenograft resorbable with membrane
    Intervention: Procedure: Ridge preservation
  • Experimental: Ridge preservation no membrane
    test patients will receive ridge preservation intrasocket allograft and overlay xenograft with no membrane
    Intervention: Procedure: Ridge preservation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
30
June 2021
June 2021   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact: Henry Greenwell, DMD, MSD 502-852-1213 henry.greenwell@louisville.edu
Contact: Abdullah Alkanan, BDS 202-320-6452 abdullah.alkanan@louisville.edu
United States
 
 
NCT02798887
16.0461
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Henry Greenwell, University of Louisville
University of Louisville
Not Provided
Principal Investigator: Henry Greenwell, DMD, MSD University of Louisville
University of Louisville
December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP