NCT02474498

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2013

Typical duration for phase_4

Geographic Reach
1 country

1 active site

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

March 1, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

June 10, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 17, 2015

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

March 20, 2017

Completed
Last Updated

March 20, 2017

Status Verified

June 1, 2015

Enrollment Period

1.8 years

First QC Date

June 10, 2015

Results QC Date

March 21, 2016

Last Update Submit

January 30, 2017

Conditions

Periodontal Disease

Keywords

Regenerative therapyRandomized clinical trial (RCT)Enamel matrix derivativeHydroxyapatite-beta tricalcium phosphateBuccal furcation

Outcome Measures

Primary Outcomes (1)

  • Relative Horizontal Clinical Attachment Level (RHCAL) at 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.

    12 months

Secondary Outcomes (3)

  • Relative Vertical Clinical Attachment Level (RVCAL) at 12 Months

    12 months

  • Periodontal Probing Depth at 12 Months

    12 months

  • Relative Gingival Margin Position (RGMP) at 12 Months

    12 months

Study Arms (3)

EMD alone

ACTIVE COMPARATOR

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: EMDProcedure: Flap access surgery

βTCP/HA alone

ACTIVE COMPARATOR

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/HAProcedure: Flap access surgery

EMD + βTCP/HA

ACTIVE COMPARATOR

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: EMDDevice: βTCP/HAProcedure: Flap access surgery

Interventions

EMDDRUG

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).

Also known as: Emdogain
EMD + βTCP/HAEMD alone
βTCP/HADEVICE

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)

Also known as: Bone Ceramic®
EMD + βTCP/HAβTCP/HA alone
Flap access surgeryPROCEDURE

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.

EMD + βTCP/HAEMD aloneβTCP/HA alone

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Piracicaba Dental School, State University of Campinas

Piracicaba, São Paulo, 13414-903, Brazil

Location

MeSH Terms

Conditions

Periodontal Diseases

Interventions

enamel matrix proteins

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Limitations and Caveats

This clinical trial did not show limitations.

Results Point of Contact

Title
Prof.Dr. Enilson Antonio Sallum
Organization
Piracicaba Dental School - University of Campinas
easallum@fop.unicamp.br
+55 19 2106-5301

Study Officials

  • Enilson A Sallum, PhD

    University of Campinas, Brazil

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, department of Periodontics, Piracicaba Dental School, State University of Campinas (UNICAMP), Piracicaba, São Paulo, Brazil

Study Record Dates

First Submitted

June 10, 2015

First Posted

June 17, 2015

Study Start

March 1, 2013

Primary Completion

December 1, 2014

Study Completion

June 1, 2015

Last Updated

March 20, 2017

Results First Posted

March 20, 2017

Record last verified: 2015-06

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)