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Furcation Therapy With Enamel Matrix Derivative

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02907528
First Posted: September 20, 2016
Last Update Posted: September 20, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Campinas, Brazil
Information provided by (Responsible Party):
Purnima Kumar, Ohio State University Comprehensive Cancer Center
  Purpose

Objective: To clinically evaluate mandibular furcation treated with Beta tricalcium phosphate/hydroxyapatite (βTCP/HA) isolated or combined with enamel matrix derivative (EMD + βTCP/HA) and EMD alone.

Material and Methods: 39 patients, presenting at least one mandibular class II furcation defect, probing pocket depth (PPD) ≥ 4 mm and bleeding on probing, were included. The defects were assigned to the βTCP/HA group 1 (n = 13); open-flap debridement (OFD) + βTCP/HA filling; βTCP/HA + EMD group 2 (n = 13); OFD + βTCP/HA + EMD filling; and EMD group 3 (n = 13) OFD + EMD filling. Plaque (PI) and gingival index (GI), PPD, relative gingival margin position (RGMP), vertical and horizontal attachment level (RVCAL and RHCAL), and furcation diagnosis were evaluated at baseline, 6 and 12 months.


Condition Intervention
Chronic Periodontitis Biological: Bone Biological: EMD

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Furcation Therapy With Enamel Matrix Derivative: Effects on the Subgingival Microbiome

Further study details as provided by Purnima Kumar, Ohio State University Comprehensive Cancer Center:

Primary Outcome Measures:
  • Shifts in the subgingival microbiome at 3 and 6 months in response to the interventions [ Time Frame: 6 months ]
    Subgingival microbial plaque samples will be collected at baseline and at the 3 and 6-month re-evaluation visits. Bacterial samples will be removed from the paper points by adding 200µl of phosphate buffered saline (PBS) and vortexing for 1 minute. The paper points were then removed, and DNA isolated using a Qiagen MiniAmp kit (Valencia, CA) according to the manufacturer's instructions. Multiplexed bacterial tag-encoded FLX amplicon pyrosequencing will be performed using the Titanium platform. High quality, classifiable sequences (quality score >25, >200bp length) were clustered into species-level operational taxonomic units (s-OTUs) at 97% sequence similarity and assigned a taxonomic identity by alignment to the HOMD database using the Blastn algorithm. Primary outcome measures will be changes in diversity, equitability and levels of pathogens.


Enrollment: 39
Study Start Date: January 2014
Study Completion Date: January 2016
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: BONE Group
bone substitute consisting of beta tricalcium phosphate/hydroxyapatite (βTCP/HA- Bone Ceramic® Straumann, Basel, Switzerland)
Biological: Bone
Furcation defect regenerated with bone graft material
Active Comparator: BONE+EMD Group
mixture of enamel matrix derivative proteins (EMD) (Emdogain® Straumann, Basel, Switzerland) and bone substitute consisting of βTCP/HA (Bone Ceramic® Straumann, Basel, Switzerland);
Biological: Bone
Furcation defect regenerated with bone graft material
Biological: EMD
Furcation defect regenerated with EMD
Experimental: EMD Group
enamel matrix derivative (EMD - Emdogain® Straumann, Basel, Switzerland)
Biological: EMD
Furcation defect regenerated with EMD

Detailed Description:
Although enamel matrix derivative (EMD) has been used to promote periodontal regeneration, little is known of its effect on the microbiome. Therefore, this investigation aimed to identify the changes in periodontal microbiome following treatment with EMD using a deep-sequencing approach. Thirty-nine patients having mandibular class II buccal furcation defects were randomized to beta-tricalcium-phosphate/hydroxyapatite graft (BONE group), EMD+BONE or EMD alone. Plaque was collected from furcation defects at baseline, 3 and 6 months post-treatment. Bacterial DNA was analyzed using terminal restriction fragment length polymorphism (t-RFLP) and 16S pyrotag sequencing. 169,000 classifiable sequences were compared to HOMD using the QIIME and PhyloToAST pipelines. Statistical comparisons were made using parametric tests. At baseline, a total of 422 species were identified from the 39 defects, belonging to Fusobacterium, Pseudomonas, Streptococcus, Filifactor and Parvimonas. All three regenerative procedures predictably altered the disease-associated microbiome, with a restitution of health-compatible species. However, EMD and BONE+EMD groups demonstrated more long-term reductions in higher number of species than in BONE group (p<0.05), especially disease-associated species e.g. Selenomonas noxia, F.alocis, and Fusobacterium. EMD may promote periodontal regeneration by predictably altering a dysbiotic subgingival microbiome, decreasing pathogen richness and increasing commensal abundance.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Untreated ChronicPeriodontitis

Exclusion Criteria:

  • Diabetes Pregnancy Current Smoking
  Contacts and Locations
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): NCT02907528


Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
University of Campinas, Brazil
Investigators
Principal Investigator: purnima Kumar Ohio State University
  More Information

Responsible Party: Purnima Kumar, Associate Professor, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02907528     History of Changes
Other Study ID Numbers: OSU-FAPESP 101
First Submitted: September 11, 2016
First Posted: September 20, 2016
Last Update Posted: September 20, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases