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

Periodontal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02474498
• Other study ID #: 035/2007
• Status: Completed
• Phase: Phase 4
• First received: June 10, 2015
• Last updated: June 12, 2015
• Start date: March 2013
• Est. completion date: June 2015

Study information

• Verified date: June 2015
• Source: University of Campinas, Brazil
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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).

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). Plaque index (PI), gingival index (GI), 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: June 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Males and females, between 18-75 years of age;

• Presence of a mandibular molar with buccal class-II furcation defect, presenting PD = 4mm, bleeding on probing (BOP), minimum (<1 mm) or no gingival recession after non-surgical therapy;

• Good general health;

• Minimum interproximal bone loss (< 2 mm).

Exclusion Criteria:

• Pregnant or lactating;

• Required antibiotic pre-medication for the performance of periodontal examination and treatment;

• Suffered from any other systemic diseases (cardiovascular, pulmonary, liver, cerebral, diseases or diabetes);

• Had received antibiotic treatment in the previous 3 months;

• Were taking long-term anti-inflammatory drugs;

• Had received a course of periodontal treatment within the last 6 months;

• Smokers.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gingival Diseases
• Periodontal Disease
• Periodontal Diseases

Intervention

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:
• ßTCP/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 (ßTCP/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.

Locations

Country	Name	City	State
Brazil	Piracicaba Dental School, State University of Campinas	Piracicaba	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Campinas, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Horizontal clinical attachment level gain	The relative horizontal clinical attachment level (RHCAL) will be measured with the same type of probe (PCP-15 Periodontal Probe - Hu-Friedy - Chicago, IL, USA) as the distance between the deepest point reached by the probe when introduced horizontally into the furcation and the lower border of the stent. This parameter will be evaluated at one specific site at the buccal furcation entrance, determined by a groove made on an individually manufactured acrylic stent and recorded to the nearest 0.5mm.	12 months	No
Secondary	Relative vertical clinical attachment level	The relative vertical clinical attachment level (RVCAL) will be measured with the same type of probe (PCP-15 Periodontal Probe - Hu-Friedy - Chicago, IL, USA) as the distance between the deepest point reached by the probe when introduced vertically into the buccal periodontal pocket. This parameter will be evaluated at one specific site at the buccal furcation entrance, determined by a groove made on an individually manufactured acrylic stent and recorded to the nearest 0.5mm.	12 months	No