Furcation Therapy With Enamel Matrix Derivative

Furcation Therapy With Enamel Matrix Derivative: Effects on the Subgingival Microbiome

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.

Study Overview

• Status: Completed
• Conditions: Chronic Periodontitis
• Intervention / Treatment: Biological: Bone; Biological: 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.

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Untreated ChronicPeriodontitis

Exclusion Criteria:

• Diabetes Pregnancy Current Smoking

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shifts in the subgingival microbiome at 3 and 6 months in response to the interventions	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.	6 months

Collaborators and Investigators

• Sponsor: Ohio State University
• Collaborators: University of Campinas, Brazil
• Investigators: Principal Investigator: purnima Kumar, Ohio State University

Publications and helpful links

General Publications

• Queiroz LA, Casarin RCV, Dabdoub SM, Tatakis DN, Sallum EA, Kumar PS. Furcation Therapy With Enamel Matrix Derivative: Effects on the Subgingival Microbiome. J Periodontol. 2017 Jul;88(7):617-625. doi: 10.1902/jop.2017.160542. Epub 2017 Mar 17.

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: September 11, 2016
• First Submitted That Met QC Criteria: September 14, 2016
• First Posted (Estimate): September 20, 2016

Study Record Updates

• Last Update Posted (Actual): March 3, 2021
• Last Update Submitted That Met QC Criteria: March 1, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Chronic Periodontitis
• Other Study ID Numbers: OSU-FAPESP 101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO