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

NCT ID: NCT03354182

Last Updated: 2017-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-30

Study Completion Date

2017-01-02

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.

Conditions

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Furcation Defects

Keywords

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Mandibular type II furcations Periodontal treatment Demineralized bovine bone mineral Collagen membrane

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized clinical study with 1 control group and 1 test group
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
The patients didn't know whether they were the control or test group

Study Groups

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Control group

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

Group Type ACTIVE_COMPARATOR

Open flap surgery

Intervention Type PROCEDURE

Elevation of a flap in order to access the treated furcation

Bio-oss collagen

Intervention Type DEVICE

Biomaterial for periodontal surgery

Bio-gide

Intervention Type DEVICE

Biomaterial for periodontal surgery

Test group

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

Group Type ACTIVE_COMPARATOR

Open flap surgery

Intervention Type PROCEDURE

Elevation of a flap in order to access the treated furcation

Bio-gide

Intervention Type DEVICE

Biomaterial for periodontal surgery

Interventions

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Open flap surgery

Elevation of a flap in order to access the treated furcation

Intervention Type PROCEDURE

Bio-oss collagen

Biomaterial for periodontal surgery

Intervention Type DEVICE

Bio-gide

Biomaterial for periodontal surgery

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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2015/03AVR/167

Identifier Type: -

Identifier Source: org_study_id