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CompletedNCT03354182Updated Dec 2, 2017

Surgical Treatment of Mandibular Furcations Using a Xenograft With/Without a Collagen Membrane

An interventional study of Open flap surgery and Bio-oss collagen in Furcation Defects, sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-12-02.

Sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 2 months after the study started (first participant enrolled Jul 2015, registered Oct 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
19
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

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. The patients all underwent the same surgical intervention with the only difference between the two groups being the use or not of a collagen membrane.

02

Conditions studied

  • Furcation Defects

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Keywords

  • Mandibular type II furcations
  • Periodontal treatment
  • Demineralized bovine bone mineral
  • Collagen membrane
03

In context

Furcation Defects

42 studies on the registry are indexed under Furcation Defects; 13 are open to participants now.

This study's enrollment of 19 is below the median of 27 across 38 interventional studies indexed under Furcation Defects.

Browse Furcation Defects studies →

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain is the lead sponsor of 350 studies on the registry; 64 are open to participants now.

Browse Cliniques universitaires Saint-Luc- Université Catholique de Louvain studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients diagnosed with chronic periodontitis
  • Initial phase (oral hygiene instructions + full mouth scaling and root planing) performed at least eight weeks before inclusion
  • 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)

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
19 participants (actual)

Study arms

  • Active comparator
    Control group

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

    Procedure: Open flap surgery · Device: Bio-oss collagen · Device: Bio-gide

  • Active comparator
    Test group

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

    Procedure: Open flap surgery · Device: Bio-gide

Interventions

  • ProcedureOpen flap surgery

    Elevation of a flap in order to access the treated furcation

  • DeviceBio-oss collagen

    Biomaterial for periodontal surgery

  • DeviceBio-gide

    Biomaterial for periodontal surgery

06

What researchers measure

Primary outcomes

  1. Horizontal Probing Attachment Level

    PAL-H

    Time frame: 6 months

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2015 to primary completion in Jan 2017, 17 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 19, 2017
First posted
Nov 27, 2017
StartActual
Jul 30, 2015
Primary completionActual
Jan 2, 2017
CompletionActual
Jan 2, 2017
Last update
Dec 2, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 2, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03354182
Lead sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Responsible party
Sponsor
First posted
Nov 27, 2017
Start date
Jul 30, 2015
Primary completion
Jan 2, 2017
Completion
Jan 2, 2017
Last update
Dec 2, 2017

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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