NCT03354182

Brief Summary

The aim of the study was to perform a randomized controlled clinical study in order to compare the effects of a bovine derived xenograft (with 10% collagen) + a bioabsorbable membrane (control group, CG) vs a bovine derived xenograft (with 10% collagen) alone (test group, TG) on the surgical treatment of mandibular type II furcation defects.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2015

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 30, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 19, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 27, 2017

Completed
Last Updated

December 2, 2017

Status Verified

June 1, 2017

Enrollment Period

1.4 years

First QC Date

October 19, 2017

Last Update Submit

November 30, 2017

Conditions

Furcation Defects

Keywords

Mandibular type II furcationsPeriodontal treatmentDemineralized bovine bone mineralCollagen membrane

Outcome Measures

Primary Outcomes (1)

  • Horizontal Probing Attachment Level

    PAL-H

    6 months

Study Arms (2)

Control group

ACTIVE COMPARATOR

Open flap surgery on mandibular type II furcations treated with Bio-oss collagen + Bio-gide

Procedure: Open flap surgeryDevice: Bio-oss collagenDevice: Bio-gide

Test group

ACTIVE COMPARATOR

Open flap surgery on mandibular type II furcations treated with Bio-oss collagen alone

Procedure: Open flap surgeryDevice: Bio-gide

Interventions

Open flap surgeryPROCEDURE

Elevation of a flap in order to access the treated furcation

Control groupTest group
Bio-oss collagenDEVICE

Biomaterial for periodontal surgery

Control group
Bio-gideDEVICE

Biomaterial for periodontal surgery

Control groupTest group

Eligibility Criteria

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

You may qualify if:

  • Patients diagnosed with chronic periodontitis
  • Full-mouth plaque score ≦ 20% (at least eight weeks after initial phase and during the whole treatment)
  • Clinical evidence of vestibular or lingual mandibular Class II furcation defects (≧ 3mm of horizontal probing depth)
  • Presence of at least 2 mm of keratinized gingiva on the selected tooth surface facing the furcation
  • Tooth vitality confirmed by clinical tests (cold testing)

You may not qualify if:

  • Presence of any systemic disease
  • Smokers
  • Devitalized tooth or tooth presenting periapical or pulpar pathology (confirmed with a retro-alveolar radiograph)
  • Allergies to any of the products used in the present study
  • Pregnant or breastfeeding women
  • History or current RX therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Furcation Defects

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The patients didn't know whether they were the control or test group
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized clinical study with 1 control group and 1 test group
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2017

First Posted

November 27, 2017

Study Start

July 30, 2015

Primary Completion

January 2, 2017

Study Completion

January 2, 2017

Last Updated

December 2, 2017

Record last verified: 2017-06