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

Primary Purpose

Furcation Defects

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Open flap surgery
Bio-oss collagen
Bio-gide
Sponsored by
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Furcation Defects focused on measuring Mandibular type II furcations, Periodontal treatment, Demineralized bovine bone mineral, Collagen membrane

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Control group

    Test group

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Horizontal Probing Attachment Level
    PAL-H

    Secondary Outcome Measures

    Full Information

    First Posted
    October 19, 2017
    Last Updated
    November 30, 2017
    Sponsor
    Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03354182
    Brief Title
    Surgical Treatment of Mandibular Furcations Using a Xenograft With/Without a Collagen Membrane
    Official Title
    Treatment of Mandibular Type II Furcations Using Bovine-derived Bone Xenograft With or Without a Collagen Membrane: a Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    July 30, 2015 (Actual)
    Primary Completion Date
    January 2, 2017 (Actual)
    Study Completion Date
    January 2, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Furcation Defects
    Keywords
    Mandibular type II furcations, Periodontal treatment, Demineralized bovine bone mineral, Collagen membrane

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized clinical study with 1 control group and 1 test group
    Masking
    Participant
    Masking Description
    The patients didn't know whether they were the control or test group
    Allocation
    Randomized
    Enrollment
    19 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control group
    Arm Type
    Active Comparator
    Arm Description
    Open flap surgery on mandibular type II furcations treated with Bio-oss collagen + Bio-gide
    Arm Title
    Test group
    Arm Type
    Active Comparator
    Arm Description
    Open flap surgery on mandibular type II furcations treated with Bio-oss collagen alone
    Intervention Type
    Procedure
    Intervention Name(s)
    Open flap surgery
    Intervention Description
    Elevation of a flap in order to access the treated furcation
    Intervention Type
    Device
    Intervention Name(s)
    Bio-oss collagen
    Intervention Description
    Biomaterial for periodontal surgery
    Intervention Type
    Device
    Intervention Name(s)
    Bio-gide
    Intervention Description
    Biomaterial for periodontal surgery
    Primary Outcome Measure Information:
    Title
    Horizontal Probing Attachment Level
    Description
    PAL-H
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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: 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

    12. IPD Sharing Statement

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

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