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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Furcation Defects

Intervention / Treatment
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* Procedure: Open flap surgery
* Device: Bio-oss collagen
* Device: Bio-gide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized clinical study with 1 control group and 1 test group
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>Open flap surgery on mandibular type II furcations treated with Bio-oss collagen + Bio-gide | Procedure: Open flap surgery<br>* Elevation of a flap in order to access the treated furcation<br>Device: Bio-oss collagen<br>* Biomaterial for periodontal surgery<br>Device: Bio-gide<br>* Biomaterial for periodontal surgery<br>|
| Active Comparator: Test group<br>Open flap surgery on mandibular type II furcations treated with Bio-oss collagen alone | Procedure: Open flap surgery<br>* Elevation of a flap in order to access the treated furcation<br>Device: Bio-gide<br>* Biomaterial for periodontal surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Horizontal Probing Attachment Level | PAL-H | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mandibular type II furcations, Periodontal treatment, Demineralized bovine bone mineral, Collagen membrane