CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 enrolled
Drug / intervention
experimental: collagen matrix +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/NCT03344315
NCT03344315N/ACompleted

Xenogeneic Collagen Matrix or Palatal Connective Tissue Graft With a Coronally Advanced Flap for the Treatment of Miller Class III Gingival Recessions

University of the Basque Country (UPV/EHU)·interventional·Posted Nov 17, 2017·Updated Apr 19, 2021

In Brief

A clinical study evaluating experimental: collagen matrix and Active Comparator: autologous connective tissue graft for Gingival Recession. Completed, enrolled 20 participants across 1 site.

Detailed Summary

The purpose of this multi-center study is to compare the effectiveness of Mucograft versus connective tissue graft in combination with coronal advanced flap for the treatment of Miller class III recessions The connective tissue graft in combination with coronal advanced flap is considered the gold standard for the treatment of gingival recession in terms of percentage of root coverage and complete root coverage. However connective tissue graft harvesting from the palatal mucosa is often associated with increased patient morbidity, prolonged surgical time and is limited supply. To overcome these inconvenients many efforts are made to develop new materials (healing modifiers, barrier membranes and grafts substitutes) Recently a new two-layer , xenogenic collagen matrix (Mucograft: Geistlich Pharma , Wolhusen Switzerland) has been proposed for regenerative therapy involving teeth and implants. The use of this porcine collagen matrix has obtained promising results for treatment of Miller class I and II recession defects (isolated and multiple recession defects) The mayority of root coverage studies in the literature treats Miller class I and II recession defects .Surgical treatment of class III recesión defects is more challenging due to loss of interproximal bone and soft tissues and complete root coverage may not be expected . But some recent studies demonstrate complete root coverage and high percentage of root coverage in class III recessions. Also a new classification system using the level of interproximal attachment level has been proposed to predict the final root coverage outcome. So ,the soft tissue substitutes should be used also in Miller class III recession, and because of that fact, the investigators are conducting this study, to evaluate the effectiveness of Mucograft in Miller class III recessions compared with connective tissue graft.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSpain
CollaboratorsGeistlich Pharma AG

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedNov 17, 2017
Enrollment StartMar 1, 2017
Primary CompletionJun 30, 2020
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 8.6 years ago

Interventions

experimental: collagen matrixdevice

Mucograft collagen matrix combined with coronal advanced flap

Active Comparator: autologous connective tissue graftother

Soft tissue harvesting from patient palate with coronal advanced flap