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

Primary Purpose

Periodontal Disease

Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
EMD
βTCP/HA
Flap access surgery
Sponsored by
University of Campinas, Brazil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontal Disease focused on measuring Regenerative therapy, Randomized clinical trial (RCT), Enamel matrix derivative, Hydroxyapatite-beta tricalcium phosphate, Buccal furcation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Piracicaba Dental School, State University of Campinas

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

EMD alone

βTCP/HA alone

EMD + βTCP/HA

Arm 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.

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)

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).

Outcomes

Primary Outcome Measures

Relative Horizontal Clinical Attachment Level (RHCAL) at 12 Months
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.

Secondary Outcome Measures

Relative Vertical Clinical Attachment Level (RVCAL) at 12 Months
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.
Periodontal Probing Depth at 12 Months
Relative Gingival Margin Position (RGMP) at 12 Months

Full Information

First Posted
June 10, 2015
Last Updated
January 30, 2017
Sponsor
University of Campinas, Brazil
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1. Study Identification

Unique Protocol Identification Number
NCT02474498
Brief Title
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

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Campinas, Brazil

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Disease
Keywords
Regenerative therapy, Randomized clinical trial (RCT), Enamel matrix derivative, Hydroxyapatite-beta tricalcium phosphate, Buccal furcation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EMD alone
Arm Type
Active Comparator
Arm 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.
Arm Title
βTCP/HA alone
Arm Type
Active Comparator
Arm 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)
Arm Title
EMD + βTCP/HA
Arm Type
Active Comparator
Arm 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).
Intervention Type
Drug
Intervention Name(s)
EMD
Other Intervention Name(s)
Emdogain
Intervention 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).
Intervention Type
Device
Intervention Name(s)
βTCP/HA
Other Intervention Name(s)
Bone Ceramic®
Intervention Description
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)
Intervention Type
Procedure
Intervention Name(s)
Flap access surgery
Intervention Description
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.
Primary Outcome Measure Information:
Title
Relative Horizontal Clinical Attachment Level (RHCAL) at 12 Months
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Relative Vertical Clinical Attachment Level (RVCAL) at 12 Months
Description
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.
Time Frame
12 months
Title
Periodontal Probing Depth at 12 Months
Time Frame
12 months
Title
Relative Gingival Margin Position (RGMP) at 12 Months
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enilson A Sallum, PhD
Organizational Affiliation
University of Campinas, Brazil
Official's Role
Principal Investigator
Facility Information:
Facility Name
Piracicaba Dental School, State University of Campinas
City
Piracicaba
State/Province
São Paulo
ZIP/Postal Code
13414-903
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

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

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