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

University of Campinas, Brazil

Status and phase: Completed; Phase 4

Conditions: Periodontal Disease

Treatments: Device: βTCP/HA; Procedure: Flap access surgery; Drug: EMD

Study type: Interventional

Funder types: Other

Identifiers

NCT02474498

035/2007

Details and patient eligibility

About

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).

Full 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.

Enrollment: 41 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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41 participants in 3 patient groups

EMD alone

Active Comparator group

Description:

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) and after the flap will be repositioned.

Treatment:

Procedure: Flap access surgery

Drug: EMD

βTCP/HA alone

Active Comparator group

Description:

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 will be filled with a bone substitute consisting of beta tricalcium phosphate/hydroxyapatite (βTCP/HA- Bone Ceramic® Straumann, Basel, Switzerland)

Treatment:

Procedure: Flap access surgery

Device: βTCP/HA

EMD + βTCP/HA

Active Comparator group

Description:

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 will be filled with a mixture of enamel matrix derivative proteins (EMD) (Emdogain® Straumann, Basel, Switzerland) and bone substitute consisting of βTCP/HA (Bone Ceramic® Straumann, Basel, Switzerland). Immediately after debridement, EMD will be applied on the root surfaces. The remaining part of the material in the seringe will be then mixed with the bone substitute on a sterile dappen. This mixture will be used to completely fill the defect (EMD + βTCP/HA).

Treatment:

Procedure: Flap access surgery

Drug: EMD

Device: βTCP/HA