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

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ClinicalTrials.gov Identifier: NCT02474498
Recruitment Status : Completed
First Posted : June 17, 2015
Results First Posted : March 20, 2017
Last Update Posted : March 20, 2017
Sponsor:
Information provided by (Responsible Party):
Enilson Antonio Sallum, University of Campinas, Brazil

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).

Condition or disease Intervention/treatment Phase
Periodontal Disease Drug: EMD Device: βTCP/HA Procedure: Flap access surgery Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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 Start Date : March 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : June 2015

Arm Intervention/treatment
Active Comparator: EMD alone
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.
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).
Other Name: Emdogain

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.

Active Comparator: βTCP/HA alone
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)
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)
Other Name: Bone Ceramic®

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.

Active Comparator: EMD + βTCP/HA
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).
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).
Other Name: Emdogain

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)
Other Name: Bone Ceramic®

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.




Primary Outcome Measures :
  1. Relative Horizontal Clinical Attachment Level (RHCAL) at 12 Months [ Time Frame: 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 :
  1. Relative Vertical Clinical Attachment Level (RVCAL) at 12 Months [ Time Frame: 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.

  2. Periodontal Probing Depth at 12 Months [ Time Frame: 12 months ]
  3. Relative Gingival Margin Position (RGMP) at 12 Months [ Time Frame: 12 months ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02474498


Locations
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Brazil
Piracicaba Dental School, State University of Campinas
Piracicaba, São Paulo, Brazil, 13414-903
Sponsors and Collaborators
University of Campinas, Brazil
Investigators
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Principal Investigator: Enilson A Sallum, PhD University of Campinas, Brazil

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Responsible Party: Enilson Antonio Sallum, Professor, department of Periodontics, Piracicaba Dental School, State University of Campinas (UNICAMP), Piracicaba, São Paulo, Brazil, University of Campinas, Brazil
ClinicalTrials.gov Identifier: NCT02474498     History of Changes
Other Study ID Numbers: 035/2007
First Posted: June 17, 2015    Key Record Dates
Results First Posted: March 20, 2017
Last Update Posted: March 20, 2017
Last Verified: June 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Enilson Antonio Sallum, University of Campinas, Brazil:
Regenerative therapy
Randomized clinical trial (RCT)
Enamel matrix derivative
Hydroxyapatite-beta tricalcium phosphate
Buccal furcation
Additional relevant MeSH terms:
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Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases