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

NCT03354182 — Not applicable, Completed, 19 participants, Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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Treatment of Mandibular Type II Furcations Using Bovine-derived Bone Xenograft With or Without a Collagen Membrane: a Randomized Clinical Trial

RegistryNCT03354182
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: single, treatment
Enrollment19 (Actual)
SponsorCliniques universitaires Saint-Luc- Université Catholique de Louvain (Other)
ConditionsFurcation Defects
InterventionsOpen flap surgery, Bio-oss collagen, Bio-gide (Procedure, device)
Datesstart 2015-07-30, primary completion 2017-01-02, completion 2017-01-02, first posted 2017-11-27, last updated 2017-12-02

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-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Control groupActive comparatorProcedure: Open flap surgery; Device: Bio-oss collagen; Device: Bio-gideOpen flap surgery on mandibular type II furcations treated with Bio-oss collagen + Bio-gide
Test groupActive comparatorProcedure: Open flap surgery; Device: Bio-gideOpen flap surgery on mandibular type II furcations treated with Bio-oss collagen alone
  • Open flap surgery (Procedure): Elevation of a flap in order to access the treated furcation
  • Bio-oss collagen (Device): Biomaterial for periodontal surgery
  • Bio-gide (Device): Biomaterial for periodontal surgery

+Outcome measures

Primary outcomes

  • Horizontal Probing Attachment Level [6 months]: PAL-H

+Eligibility

Sex: All, ages: 18 Years to any

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

My Notes