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

C

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status

Completed

Conditions

Furcation Defects

Treatments

Device: Bio-gide
Device: Bio-oss collagen
Procedure: Open flap surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT03354182
2015/03AVR/167

Details and patient eligibility

About

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.

Full 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.

Enrollment

19 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

19 participants in 2 patient groups

Control group
Active Comparator group
Description:
Open flap surgery on mandibular type II furcations treated with Bio-oss collagen + Bio-gide
Treatment:
Device: Bio-gide
Device: Bio-oss collagen
Procedure: Open flap surgery
Test group
Active Comparator group
Description:
Open flap surgery on mandibular type II furcations treated with Bio-oss collagen alone
Treatment:
Device: Bio-gide
Procedure: Open flap surgery

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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