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

Not Applicable

Completed

• Conditions: Furcation Defects
• Interventions: Procedure: Open flap surgery; Device: Bio-oss collagen; Device: Bio-gide

• Registration Number: NCT03354182
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2015-07-30
• Primary Completion: 2017-01-02
• Study Completion: 2017-01-02
• Status Verified: 2017-06
• Study First Submitted: 2017-10-19
• Study First Submitted QC: 2017-11-23
• Study First Posted: 2017-11-27
• Last Update Submitted: 2017-11-30
• Last Update Posted: 2017-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Bio-oss collagen	Open flap surgery on mandibular type II furcations treated with Bio-oss collagen + Bio-gide
Control group	Bio-gide	Open flap surgery on mandibular type II furcations treated with Bio-oss collagen + Bio-gide
Test group	Bio-gide	Open flap surgery on mandibular type II furcations treated with Bio-oss collagen alone
Control group	Open flap surgery	Open flap surgery on mandibular type II furcations treated with Bio-oss collagen + Bio-gide
Test group	Open flap surgery	Open flap surgery on mandibular type II furcations treated with Bio-oss collagen alone

Primary Outcome Measures

Name	Time	Method
Horizontal Probing Attachment Level	6 months	PAL-H