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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03354182
Enrollment
19
Registered
2017-11-27
Start date
2015-07-30
Completion date
2017-01-02
Last updated
2017-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Furcation Defects

Keywords

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

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.

Interventions

Elevation of a flap in order to access the treated furcation

DEVICEBio-oss collagen

Biomaterial for periodontal surgery

DEVICEBio-gide

Biomaterial for periodontal surgery

Sponsors

Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

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

Intervention model description

Randomized clinical study with 1 control group and 1 test group

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Horizontal Probing Attachment Level6 monthsPAL-H

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026