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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03354182
Recruitment Status : Completed
First Posted : November 27, 2017
Last Update Posted : December 2, 2017
Sponsor:
Information provided by (Responsible Party):
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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.

Condition or disease Intervention/treatment Phase
Furcation Defects Procedure: Open flap surgery Device: Bio-oss collagen Device: Bio-gide Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized clinical study with 1 control group and 1 test group
Masking: Single (Participant)
Masking Description: The patients didn't know whether they were the control or test group
Primary Purpose: Treatment
Official Title: Treatment of Mandibular Type II Furcations Using Bovine-derived Bone Xenograft With or Without a Collagen Membrane: a Randomized Clinical Trial
Actual Study Start Date : July 30, 2015
Actual Primary Completion Date : January 2, 2017
Actual Study Completion Date : January 2, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Collagen

Arm Intervention/treatment
Active Comparator: Control group
Open flap surgery on mandibular type II furcations treated with Bio-oss collagen + Bio-gide
Procedure: Open flap surgery
Elevation of a flap in order to access the treated furcation

Device: Bio-oss collagen
Biomaterial for periodontal surgery

Device: Bio-gide
Biomaterial for periodontal surgery

Active Comparator: Test group
Open flap surgery on mandibular type II furcations treated with Bio-oss collagen alone
Procedure: Open flap surgery
Elevation of a flap in order to access the treated furcation

Device: Bio-gide
Biomaterial for periodontal surgery




Primary Outcome Measures :
  1. Horizontal Probing Attachment Level [ Time Frame: 6 months ]
    PAL-H



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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Responsible Party: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT03354182    
Other Study ID Numbers: 2015/03AVR/167
First Posted: November 27, 2017    Key Record Dates
Last Update Posted: December 2, 2017
Last Verified: June 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:
Mandibular type II furcations
Periodontal treatment
Demineralized bovine bone mineral
Collagen membrane
Additional relevant MeSH terms:
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Furcation Defects
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases