Furcation Therapy With Enamel Matrix Derivative

NCT ID: NCT02907528

Last Updated: 2021-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2016-01-31

Brief Summary

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.

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.

Conditions

Chronic Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

BONE Group

bone substitute consisting of beta tricalcium phosphate/hydroxyapatite (βTCP/HA- Bone Ceramic® Straumann, Basel, Switzerland)

Group Type: PLACEBO_COMPARATOR

Bone

Intervention Type: BIOLOGICAL

Furcation defect regenerated with bone graft material

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);

Group Type: ACTIVE_COMPARATOR

Bone

Intervention Type: BIOLOGICAL

Furcation defect regenerated with bone graft material

EMD

Intervention Type: BIOLOGICAL

Furcation defect regenerated with EMD

EMD Group

enamel matrix derivative (EMD - Emdogain® Straumann, Basel, Switzerland)

Group Type: EXPERIMENTAL

EMD

Intervention Type: BIOLOGICAL

Furcation defect regenerated with EMD

Interventions

Bone

Furcation defect regenerated with bone graft material

Intervention Type: BIOLOGICAL

EMD

Furcation defect regenerated with EMD

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Untreated ChronicPeriodontitis

Exclusion Criteria

• Diabetes Pregnancy Current Smoking

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Campinas, Brazil

OTHER

Sponsor Role: collaborator

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Purnima Kumar

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

purnima Kumar

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

References

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.

Reference Type: DERIVED

PMID: 28304211 (View on PubMed)

Other Identifiers

OSU-FAPESP 101

Identifier Type: -

Identifier Source: org_study_id