CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 40 enrolled
Drug / intervention
Recession coverage without Emdogain +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/NCT02230787
NCT02230787Phase 4Completed

Effect of Emdogain on Wound Healing After Gingival Recession Coverage Using Connective Tissue Graft: A Pilot Study

University of Bern·interventional·Posted Sep 3, 2014·Updated Apr 20, 2017

In Brief

A Phase 4 clinical trial evaluating Recession coverage without Emdogain and Recession coverage with Emdogain for Gingival Recession and Emdogain. Completed, enrolled 40 participants across 1 site.

Detailed Summary

Enamel matrix proteins have been shown to play a crucial role during tooth development and its supporting tissues. This is used in periodontal surgery where regeneration of lost tissues around the teeth is intended. Emdogain, a product of Straumann Institute contains these matrix proteins and has been successfully used in regenerative periodontal surgery for more than 16 years. The treatment of gum recession is a common requirement, more and more patients are seeking treatment at the investigators' clinic due to aesthetic concern, root sensitivity and difficulties in performing adequate oral hygiene. The standard treatment comprises the transplantation of a piece of connective tissue from the palate to the denuded root surface. In many cases Emdogain is additionally applied to enhance healing. So far the effect of Emdogain on the early wound healing process after surgical root coverage has not been investigated. The purpose of the investigators' study is to compare early wound healing parameters between treatment with and without Emdogain. For this study 40 patients undergoing root coverage surgery at the investigators' department will be included. Early wound healing features between the two groups will be described and compared. Furthermore, inflammatory markers typical for early healing will be evaluated together with patients'subjective postoperative comfort. Finally, outcomes 6 months after the treatment will be assessed. The investigators' hypothesis is that Emdogain treatment enhances wound healing and decreases post-operative complication rates.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSwitzerland
Collaborators--

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedSep 3, 2014
Enrollment StartAug 1, 2014
Primary CompletionApr 22, 2016
Study CompletionFeb 14, 2017
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 11.8 years ago

Interventions

Recession coverage without Emdogaindevice

In the control group subjects the recession coverage surgery will be performed without Emdogain.

Recession coverage with Emdogaindevice

In the test group subjects the recession coverage surgery will be performed with Emdogain.