Furcation DefectsNCT03354182
Surgical Treatment of Mandibular Furcations Using a Xenograft With/Without a Collagen Membrane
A study testing Open flap surgery, Bio-oss collagen and Bio-gide in people with Furcation Defects, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Furcation Defects
- What is being tested?
- Open flap surgery, Bio-oss collagen and Bio-gide
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- No sites listed yet
- Study dates
- 30 Jul 2015to 2 Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Furcation Defects
- Being tested
- Open flap surgery, Bio-oss collagen, Bio-gide
- Keywords
- Mandibular type II furcations, Periodontal treatment, Demineralized bovine bone mineral, Collagen membrane
- Medical subject headings
- Furcation Defects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open flap surgeryProcedure or surgery
Elevation of a flap in order to access the treated furcation
Bio-oss collagenDevice
Biomaterial for periodontal surgery
Bio-gideDevice
Biomaterial for periodontal surgery
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Open flap surgery on mandibular type II furcations treated with Bio-oss collagen + Bio-gide Receives: Procedure: Open flap surgery; Device: Bio-oss collagen; Device: Bio-gide |
| Test group | Active comparator | Open flap surgery on mandibular type II furcations treated with Bio-oss collagen alone Receives: Procedure: Open flap surgery; Device: Bio-gide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Horizontal Probing Attachment Level
PAL-H
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2017
- Study start30 Jul 2015
- Primary completion2 Jan 2017
- Study completion2 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Furcation DefectsStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical study with 1 control group and 1 test group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03354182
- Sponsor's protocol ID
- 2015/03AVR/167
- Status last verified
- Jun 2017
- First submitted
- 19 Oct 2017
- Last updated
- 2 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Mandibular Type II Furcations Using Bovine-derived Bone Xenograft With or Without a Collagen Membrane: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03354182
- Acronym / sponsor ID
- 2015/03AVR/167
- Conditions
- Furcation Defects
- Keywords
- Mandibular type II furcations, Periodontal treatment, Demineralized bovine bone mineral, Collagen membrane
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 30 Jul 2015 (actual)
- Primary completion
- 2 Jan 2017 (actual)
- Study completion
- 2 Jan 2017 (actual)
- First posted
- 27 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized clinical study with 1 control group and 1 test group
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Procedure: Open flap surgery, Device: Bio-oss collagen, Device: Bio-gideOpen flap surgery on mandibular type II furcations treated with Bio-oss collagen + Bio-gide |
| Test group | Active comparator | Procedure: Open flap surgery, Device: Bio-gideOpen flap surgery on mandibular type II furcations treated with Bio-oss collagen alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Open flap surgeryElevation of a flap in order to access the treated furcation | Procedure or surgery | Control group, Test group |
| Bio-oss collagenBiomaterial for periodontal surgery | Device | Control group |
| Bio-gideBiomaterial for periodontal surgery | Device | Control group, Test group |
Primary outcome
Horizontal Probing Attachment Level
Time frame: 6 months
PAL-H
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Open flap surgery, Bio-oss collagen and Bio-gide in people with Furcation Defects, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Horizontal Probing Attachment Level (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2017.