A Prospective Study: Alveolar Ridge Augmentation Using Tenting Screws, Acellular Dermal Matrix and Combination Particulate Grafts

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Brian L Mealey, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:
NCT01572298
First received: April 3, 2012
Last updated: August 13, 2013
Last verified: August 2013
  Purpose

When a tooth or teeth are extracted, a defect in the bony ridge often forms. This loss of bone may make it impossible to place a dental implant. Guided bone regeneration procedures are used to re-establish a bone dimension sufficient to place a dental implant. The primary objective of the study is to determine whether there is any difference in the gain of horizontal alveolar ridge width following guided bone regeneration surgery using a combined autogenous/allogenic particulate bone graft versus a particulate allograft alone. Autogenous bone has historically been considered the gold standard for alveolar ridge grafting; however, other materials including allografts and xenografts have also been used with excellent results. This study evaluates the potential benefits, or lack thereof, for using a combined autogenous/allograft approach versus an allograft alone. The investigators will clinically evaluate the efficacy of this technique and determine the difference in bone formation between groups following healing at 5 months by observing bone growth relative to heads of the tenting screws placed horizontally in the locations of greatest defect in the alveolar ridge. A biopsy of the healed site will be taken at the time of implant placement. The null hypothesis is that there will be no difference in the amount of horizontal ridge width gain at 5 months post-grafting between the two different grafting materials (allograft alone versus allograft combined with autogenous bone). Furthermore, the null hypothesis is that histologically, the combination graft (MinerOss®/particulate autograft) will have a similar percentage of vital bone present at 5 months compared to the allograft-alone group (MinerOss®).


Condition Intervention
Dental Alveolus
Oral Surgical Procedures, Preprosthetic
Device: allograft alone (MinerOss allograft plus Alloderm GBR membrane)
Device: allograft combined wtih autograft (combined autogenous graft and MinerOss allograft plus Alloderm GBR membrane)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Study: Alveolar Ridge Augmentation Using Tenting Screws, Acellular Dermal Matrix and Combination Particulate Grafts.

Further study details as provided by The University of Texas Health Science Center at San Antonio:

Primary Outcome Measures:
  • Gain in horizontal ridge dimension [ Time Frame: 5 months after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • percentage of new bone formation (histologic) [ Time Frame: 5 months after surgery ] [ Designated as safety issue: No ]

Enrollment: 34
Study Start Date: April 2012
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: allograft alone
guided bone regeneration with allograft alone (includes tenting screws and overlying allograft membrane material)
Device: allograft alone (MinerOss allograft plus Alloderm GBR membrane)
use of MinerOss allograft plus Alloderm GBR membrane and tenting screws
Experimental: allograft combined with autograft
guided bone regeneration with allograft and autograft combined (includes tenting screws and overlying allograft membrane material)
Device: allograft combined wtih autograft (combined autogenous graft and MinerOss allograft plus Alloderm GBR membrane)
use of a combined autogenous graft and MinerOss allograft plus Alloderm GBR membrane and tenting screws

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • subject with a partially edentulous ridge of the maxilla or mandible with at least one tooth-span in length and inadequate buccolingual dimension for dental implant placement as measured clinically and radiographically
  • live within "catchment area" of 50 mile radius from San Antonio

Exclusion Criteria:

  • unstable systemic disease (such as compromised immune system)
  • patient taking steroids or other medications affecting bone metabolism
  • patient with history of radiation therapy to head & neck
  • history of previous ridge augmentation procedure or pathology at local jaw site
  • smokers who smoke > 10 cigarettes per day
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01572298

Locations
United States, Texas
University of texas Health Science Center Dental School at San Antonio
San Antonio, Texas, United States, 78229-3900
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Investigators
Principal Investigator: Brian L Mealey, DDS, MS Univ of Texas Health Science Center at San Antonio
  More Information

No publications provided

Responsible Party: Brian L Mealey, Graduate Program Director, Dept of Periodontics, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT01572298     History of Changes
Other Study ID Numbers: HSC20120108H
Study First Received: April 3, 2012
Last Updated: August 13, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on August 21, 2014