Ridge Preservation Comparing and Intrasocket Graft Alone to an Intrasocket Graft Plus a Facial Overlay Graft

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by University of Louisville.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Henry Greenwell, University of Louisville
ClinicalTrials.gov Identifier:
NCT01431131
First received: September 7, 2011
Last updated: September 8, 2011
Last verified: September 2011
  Purpose

The purpose of this study is to compare two methods of ridge preservation in the maxillary anterior esthetic zone to determine the best method to establish adequate bone and soft tissue to accommodate implant placement. For the positive control group a mineralized cancellous allograft will be placed in the extraction socket. For the test group a mineralized cancellous allograft will be placed in the extraction socket plus an additional graft will be placed to overlay the facial surface of the socket that will be composed of bovine xenograft material. Outcomes will be clinical horizontal and vertical dimensional change and histologic analysis of the graft material at 4 months post-placement.


Condition Intervention
Socket Healing
Procedure: Ridge preservation intrasocket graft
Procedure: Intrasocket graft plus a facial overlay graft

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ridge Preservation Comparing the Clinical and Histologic Healing of an Intrasocket Mineralized Cancellous Allograft vs. an Intrasocket Mineralized Cancellous Allograft Plus a Facial Overlay Graft Using Bovine Xenograft With a Bioabsorbable Barrier Membrane

Further study details as provided by University of Louisville:

Primary Outcome Measures:
  • Horizontal ridge dimension [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    WIll be measured with a digital caliper


Secondary Outcome Measures:
  • Histologic healing of the osseous graft [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Histologic analysis to determine vital bone, nonvital bone, and trabecular space percentages


Estimated Enrollment: 30
Study Start Date: September 2011
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Intrasocket graft
Positive control
Procedure: Ridge preservation intrasocket graft
Intrasocket mineralized cancellous allograft
Experimental: Intrasocket plus facial overlay graft
Includes facial overlay graft
Procedure: Intrasocket graft plus a facial overlay graft
Intrasocket mineralized cancellous allograft plus a facial overlay graft of bovine xenograft

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 person that 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. Molar teeth.
  3. Presence of or history of osteonecrosis of the jaws.
  4. Patients who are currently taking IV bisphosphonates or who had IV treatment with bisphosphonates irrespective of the duration.
  5. Patients who have been treated with oral bisphosphonates for more than three years.
  6. Pregnant women due to the possibility of miscarriage.
  7. Patients with an allergy to any material or medication used in the study.
  8. Patients who need prophylactic antibiotics.
  9. Previous head and neck radiation therapy.
  10. Chemotherapy in the previous 12 months.
  11. Patients on long term NSAID or steroid therapy.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01431131

Contacts
Contact: Evmenios Poulias, DDS 502-819-3493 epoulias@yahoo.gr

Locations
United States, Kentucky
Graduate Periodontics Clinic, School of Dentistry, University of Louisville Not yet recruiting
Louisville, Kentucky, United States, 40202
Sub-Investigator: Evmenios Poulias, DDS         
Sponsors and Collaborators
University of Louisville
Investigators
Principal Investigator: Henry Greenwell, DMD University of Louisville
  More Information

No publications provided

Responsible Party: Henry Greenwell, Principal Investigator, University of Louisville
ClinicalTrials.gov Identifier: NCT01431131     History of Changes
Other Study ID Numbers: 11.0352
Study First Received: September 7, 2011
Last Updated: September 8, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Louisville:
graft placement
bone resorption

ClinicalTrials.gov processed this record on April 17, 2014