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

November 30, 2017 updated by: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 30, 2015

Primary Completion (Actual)

January 2, 2017

Study Completion (Actual)

January 2, 2017

Study Registration Dates

First Submitted

October 19, 2017

First Submitted That Met QC Criteria

November 23, 2017

First Posted (Actual)

November 27, 2017

Study Record Updates

Last Update Posted (Actual)

December 2, 2017

Last Update Submitted That Met QC Criteria

November 30, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015/03AVR/167

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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