CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 41 enrolled
Drug / intervention
EMD +2 moredrug
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/NCT02474498
NCT02474498Phase 4Completed
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Enamel Matrix Protein Derivative and/or Synthetic Bone Substitute for the Treatment of Mandibular Class II Buccal Furcation Defects. A 12-month Randomized Clinical Trial

University of Campinas, Brazil·interventional·Posted Jun 17, 2015·Updated Mar 20, 2017

In Brief

A Phase 4 clinical trial evaluating EMD, βTCP/HA, and 1 other intervention for Periodontal Disease. Completed, enrolled 41 participants across 1 site.

Detailed Summary

To clinically evaluate the treatment of mandibular class II furcation defects with enamel matrix derivative (EMD) and/or a bone substitute graft make of beta tricalcium phosphate/hydroxyapatite (βTCP/HA).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeriodontal Disease
CountriesBrazil
Collaborators--

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJun 17, 2015
Enrollment StartMar 1, 2013
Primary CompletionDec 1, 2014
Study CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 11.0 years ago

Interventions

EMDdrug

During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation defects in this group will receive the application of enamel matrix derivative (EMD - Emdogain® Straumann, Basel, Switzerland).

βTCP/HAdevice

During flap access surgery, the granulation tissue will be removed and the root surfaces were carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a bone substitute consisting of beta tricalcium phosphate/hydroxyapatite (βTCP/HA- Bone Ceramic® Straumann, Basel, Switzerland)

Flap access surgeryprocedure

In the furcation sites, during flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments.