NCT02907528

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2014

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 20, 2016

Completed
Last Updated

March 3, 2021

Status Verified

March 1, 2021

Enrollment Period

11 months

First QC Date

September 11, 2016

Last Update Submit

March 1, 2021

Conditions

Chronic Periodontitis

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

BONE Group

PLACEBO COMPARATOR

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

Biological: Bone

BONE+EMD Group

ACTIVE COMPARATOR

mixture of enamel matrix derivative proteins (EMD) (Emdogain® Straumann, Basel, Switzerland) and bone substitute consisting of βTCP/HA (Bone Ceramic® Straumann, Basel, Switzerland);

Biological: BoneBiological: EMD

EMD Group

EXPERIMENTAL

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

Biological: EMD

Interventions

BoneBIOLOGICAL

Furcation defect regenerated with bone graft material

BONE GroupBONE+EMD Group
EMDBIOLOGICAL

Furcation defect regenerated with EMD

BONE+EMD GroupEMD Group

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Untreated ChronicPeriodontitis

You may not qualify if:

  • Diabetes Pregnancy Current Smoking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 28304211DERIVED

MeSH Terms

Conditions

Chronic Periodontitis

Condition Hierarchy (Ancestors)

PeriodontitisPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • purnima Kumar

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 11, 2016

First Posted

September 20, 2016

Study Start

January 1, 2014

Primary Completion

December 1, 2014

Study Completion

January 1, 2016

Last Updated

March 3, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share