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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01431131
First Posted: September 9, 2011
Last Update Posted: January 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Henry Greenwell, University of Louisville
  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
Clinical Efficacy Procedure: Intrasocket graft Procedure: Intrasocket plus facial overlay graft

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ridge Preservation Comparing a Socket Allograft Alone to a Socket Allograft Plus a Facial Overlay Xenograft: A Clinical and Histologic Study In Humans

Further study details as provided by Henry Greenwell, University of Louisville:

Primary Outcome Measures:
  • Horizontal Ridge Dimension [ Time Frame: Baseline and 4 months ]
    WIll be measured with a digital caliper at baseline and 4 months.


Secondary Outcome Measures:
  • Histologic Healing of the Osseous Graft [ Time Frame: 4 months ]
    Histologic analysis to determine vital bone, nonvital bone, and trabecular space percentages


Enrollment: 24
Study Start Date: September 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Intrasocket graft
Positive control
Procedure: Intrasocket graft
Intrasocket mineralized cancellous allograft
Experimental: Intrasocket plus facial overlay graft
Intrasocket cancellous allograft plus a facial overlay bovine xenograft
Procedure: Intrasocket plus facial overlay graft
Intrasocket mineralized cancellous allograft plus a facial overlay graft of bovine xenograft

Detailed Description:
Subjects met the eligibility criteria if they were at least 18 years of age and had one nonmolar tooth requiring extraction that would be replaced by a dental implant. Extraction sites were bordered by at least one tooth. Exclusion criteria included: 1) debilitating systemic diseases, or diseases that have a clinically significant effect on the periodontium; 2) molar extraction sites; 3) presence of or history of osteonecrosis of the jaws; 4) history of IV bisphosphonate treatment; 5) history of oral bisphosphonate treatment for more than three years; 6) pregnancy or lactation; 7) known allergy to any material or medication used in the study; 8) required antibiotic prophylaxis; 9) previous head and neck radiation therapy; 10) history of chemotherapy in the last 12 months; 11) long term steroid or non-steroidal anti-inflammatory drug therapy; or 12) failure to sign an informed consent approved by the Human Studies Committee. Patients were excluded post-treatment if they developed infection or had an adverse reaction to any of the materials used in the study.
  Eligibility

Information from the National Library of Medicine

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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 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
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): NCT01431131


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

Responsible Party: Henry Greenwell, Principal Investigator, University of Louisville
ClinicalTrials.gov Identifier: NCT01431131     History of Changes
Other Study ID Numbers: 11.0352
First Submitted: September 7, 2011
First Posted: September 9, 2011
Results First Submitted: July 7, 2013
Results First Posted: January 31, 2017
Last Update Posted: January 31, 2017
Last Verified: December 2016

Keywords provided by Henry Greenwell, University of Louisville:
graft placement
bone resorption