CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 34 enrolled
Drug / intervention
allograft alone +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01572298
NCT01572298N/ACompleted

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

The University of Texas Health Science Center at San Antonio·interventional·Posted Apr 6, 2012·Updated Jan 2, 2018

In Brief

A clinical study evaluating allograft alone and allograft with autograft for Dental Alveolus and Oral Surgical Procedures, Preprosthetic. Completed, enrolled 34 participants across 1 site.

Detailed Summary

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®).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedApr 6, 2012
Enrollment StartApr 1, 2012
Primary CompletionJul 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 14.2 years ago

Interventions

allograft alonedevice

use of MinerOss allograft plus Alloderm GBR membrane and tenting screws

allograft with autograftdevice

use of a combined autogenous graft and MinerOss allograft plus Alloderm GBR membrane and tenting screws