A Prospective Study: Alveolar Ridge Augmentation Using Tenting Screws, Acellular Dermal Matrix and Combination Particulate Grafts
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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. |
- Gain in horizontal ridge dimension [ Time Frame: 5 months after surgery ] [ Designated as safety issue: No ]
- percentage of new bone formation (histologic) [ Time Frame: 5 months after surgery ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 34 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | November 2014 |
| Estimated Primary Completion Date: | November 2014 (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 |
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| Contact: Brian L Mealey, DDS, MS | 210-567-3567 | mealey@uthscsa.edu |
| United States, Texas | |
| University of texas Health Science Center Dental School at San Antonio | Recruiting |
| San Antonio, Texas, United States, 78229-3900 | |
| 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: | November 29, 2012 |
| Health Authority: | United States: Institutional Review Board |
ClinicalTrials.gov processed this record on June 18, 2013