Clinical trial NCT02474498: EMD and/or Bone Substitute for the Treatment of Class II Furcations
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Periodontal Disease
Keywords: Regenerative therapy
Randomized clinical trial (RCT)
Enamel matrix derivative
Hydroxyapatite-beta tricalcium phosphate
Buccal furcation
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
First posted: 2015-06-17
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Relative Horizontal Clinical Attachment Level (RHCAL) at 12 Months
timeFrame: 12 months
Secondary outcomes:
measure: Relative Vertical Clinical Attachment Level (RVCAL) at 12 Months
timeFrame: 12 months
measure: Periodontal Probing Depth at 12 Months
timeFrame: 12 months
measure: Relative Gingival Margin Position (RGMP) at 12 Months
timeFrame: 12 months
Other outcomes:
Locations:
city: Piracicaba
country: Brazil
facility: Piracicaba Dental School, State University of Campinas
state: São Paulo
Study officials:
affiliation: University of Campinas, Brazil
name: Enilson A Sallum, PhD
role: PRINCIPAL_INVESTIGATOR
References: