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

Furcation Defects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03354182
• Other study ID #: 2015/03AVR/167
• Status: Completed
• Phase: N/A
• First received: October 19, 2017
• Last updated: November 30, 2017
• Start date: July 30, 2015
• Est. completion date: January 2, 2017

Study information

• Verified date: June 2017
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: January 2, 2017
• Est. primary completion date: January 2, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Furcation Defects

Intervention

Procedure:
• Open flap surgery
Elevation of a flap in order to access the treated furcation

Device:
• Bio-oss collagen
Biomaterial for periodontal surgery
• Bio-gide
Biomaterial for periodontal surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Horizontal Probing Attachment Level	PAL-H	6 months