NCT02474498

EMD and/or Bone Substitute for the Treatment of Class II Furcations

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: University of Campinas, Brazil · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Detailed description

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). Forty-one patients, presenting a mandibular class II buccal furcation defect, probing pocket depth (PPD) ≥ 4 mm and bleeding on probing, will be included. They will be randomly assigned to the groups: 1- EMD (n = 13); 2- βTCP/HA (n = 14); 3- EMD + βTCP/HA (n = 14). Relative gingival margin position (RGMP), relative vertical and horizontal attachment level (RVCAL and RHCAL) and PPD will be evaluated at baseline and 12 months. The mean horizontal clinical attachment level gain will be considered the primary outcome variable.

Conditions

• Periodontal Disease

Interventions

Type	Name	Description
DRUG	EMD	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).
DEVICE	βTCP/HA	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)
PROCEDURE	Flap access surgery	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.

Timeline

• Start date: 2013-03-01
• Primary completion: 2014-12-01
• Completion: 2015-06-01
• First posted: 2015-06-17
• Last updated: 2017-03-20
• Results posted: 2017-03-20

Locations

1 site across 1 country: Brazil