Furcation DefectsPhase 4FURC-II-REGENNCT04059445

Mandibular Furcation II Regeneration

A Phase 4 study testing Biphasic calcium phosphate (Straumann Bone Ceramic) + collagen membrane (Straumann Jason Membrane) and Biphasic calcium phosphate (Straumann Bone Ceramic) + enamel matrix proteins (Straumann Emdogain) in people with Furcation Defects and Periodontal Diseases, run by University of Oslo at 1 site in Norway.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Teeth with furcation grade II defects will be treated with open flap debridement and regenerative therapy with biphasic calcium phosphate combined with either enamel matrix proteins or a collagen membrane. Read more about this study

Who is it for?: Ages 20 years and olderHealthy volunteers can take part
Conditions the study is for: Furcation Defects, Periodontal Diseases
What is being tested?: Biphasic calcium phosphate (Straumann Bone Ceramic) + collagen membrane (Straumann Jason Membrane) and Biphasic calcium phosphate (Straumann Bone Ceramic) + enamel matrix proteins (Straumann Emdogain)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 5 participants
Where: 1 siteNorway
Study dates: 15 Oct 2019to 27 Nov 2023
Phase: Phase 4
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 20 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Subject must be ≥ 20 years
Subject must have periodontal disease as determined by the World Workshop 2017 criteria
Subjects must be undergoing periodontal treatment or follow-up and present 1 or more pair of bilateral mandibular molars affected by furcation involvement grade II with PPD >4 mm, and the furcation fornix must be below a tangential line from the distal to mesial interproximal crestal bone level
Competent to give consent

Who cannot join

The following must not be present at the time of enrolment;
Previous radiotherapy to the jaws, current use of chemotherapy, systemic long-term corticosteroid treatment
Present or past use of bisphosphonate treatment
Pregnant or nursing subjects
Patients classified as > class 2 according to the ASA (American Society of Anesthesiologists) physical status classification
Previous surgical therapy of included furcation defects

Show all 11Show fewer

Inability to comprehend and respond to the quality of life questionnaire
Dental restorations or prosthesis involving the furcation area
Root fractures or suspected infractions
Caries lesions in the furcation area
No systemic antibiotic treatment within 3 months prior to intervention

Trial locations and contacts

1 site in 1 country.

Norway1 site

Institute of Clinical Dentistry, Faculty of Dentistry, University of Oslo
Oslo, 0455

Other trials in Norway

About this study

Official title: Biphasic Calcium Phosphate and a Collagen Membrane or Biphasic Calcium Phosphate and Enamel Matrix Proteins, in the Regenerative Treatment of Furcation Grade II Defects

Conditions: Furcation Defects, Periodontal Diseases
Being tested: Biphasic calcium phosphate (Straumann Bone Ceramic) + collagen membrane (Straumann Jason Membrane), Biphasic calcium phosphate (Straumann Bone Ceramic) + enamel matrix proteins (Straumann Emdogain)
Medical subject headings: Furcation Defects, Periodontal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Biphasic calcium phosphate (Straumann Bone Ceramic) + collagen membrane (Straumann Jason Membrane)Device
Regenerative therapy with biphasic calcium phosphate + collagen membrane.
Biphasic calcium phosphate (Straumann Bone Ceramic) + enamel matrix proteins (Straumann Emdogain)Drug
Regenerative therapy with biphasic calcium phosphate + enamel matrix proteins.

Study groups in NCT04059445
Study group	Role	What they receive
Regenerative therapy w/BCP and collagen membrane	Experimental	In this arm, treatment of furcation grade II defects includes open flap debridement and regenerative therapy with biphasic calcium phosphate (BCP) and collagen membrane. Receives: Device: Biphasic calcium phosphate (Straumann Bone Ceramic) + collagen membrane (Straumann Jason Membrane); Drug: Biphasic calcium phosphate (Straumann Bone Ceramic) + enamel matrix proteins (Straumann Emdogain)
Regenerative therapy w/BCP and enamel matrix proteins	Active comparator	In this arm, treatment of furcation grade II defects includes open flap debridement and regenerative therapy with biphasic calcium phosphate (BCP) and enamel matrix proteins. Receives: Device: Biphasic calcium phosphate (Straumann Bone Ceramic) + collagen membrane (Straumann Jason Membrane); Drug: Biphasic calcium phosphate (Straumann Bone Ceramic) + enamel matrix proteins (Straumann Emdogain)

What is being measured

The primary outcome is the main question the study is designed to answer.

Change of furcation grade level
Proportion of sites demonstrating improvement in furcation grade level as measured with Nabers probe
Measured: 12 months after treatment
Change of furcation grade level
Proportion of sites demonstrating improvement in furcation grade level as measured with Nabers probe
Measured: 24 months after treatment

Secondary outcomes (12)

Changes in patient-reported quality of life (QoL)
To assess QoL changes related to mouth and teeth prior to therapy to after therapy by the use of "The Oral Impacts on Daily Performance (OIDP)" instrument. Each question is assessed by a 5-point scale; (1) never affected, (2) less than once a month, (3) once or twice a month, (4) once or twice a week; and (5) every or nearly every day. The higher number represents more severe impact on quality of life; e.g. worse outcome.
Each item will be dichotomised yielding the categories (A) affected; including scale categories (2)-(5), and (B) unaffected, including category (1).
Measured: Preoperatively compared to 24 months after treatment
Changes in patient-reported quality of life (QoL)
To assess QoL changes related to mouth and teeth prior to therapy to after therapy by the use of "The Oral Impacts on Daily Performance (OIDP)" instrument. Each question is assessed by a 5-point scale; (1) never affected, (2) less than once a month, (3) once or twice a month, (4) once or twice a week; and (5) every or nearly every day. The higher number represents more severe impact on quality of life; e.g. worse outcome.
Each item will be dichotomised yielding the categories (A) affected; including scale categories (2)-(5), and (B) unaffected, including category (1).
Measured: Preoperatively compared to 12 months after treatment
Changes in defect morphology assessed by CBCT
Cone beam computed tomography will be acquired at baseline, 2 weeks postoperatively and 24 months postoperatively. This outcome measures quantitative morphologic changes in the furcation defects at 24 months
Measured: 24 months after treatment
Changes in CAL
Changes in clinical attachment level will be measured with a probe in mm
Measured: 12 months after treatment
Changes in CAL
Changes in clinical attachment level will be measured with a probe in mm
Measured: 24 months after treatment
Changes in PPD
Changes in pocket probing depth will be measured with a probe in mm
Measured: 12 months after treatment
Changes in PPD
Changes in pocket probing depth will be measured with a probe in mm
Measured: 24 months after treatment
Radiographic changes
Standardized intraoral bitewing radiographs will be obtained and compared to baseline radiographs
Measured: 12 months after treatment
Radiographic changes
Standardized intraoral bitewing radiographs will be obtained and compared to baseline radiographs
Measured: 24 months after treatment
Pain following surgery
Pain sensation for one week posteoperatively will be recorded on a visual analog scale scale from 0-10. 0 is equivalent to no pain, whereas 10 is the highest pain imagineable.
Measured: Daily for 1 week postoperatively
Caries assessment
Caries in furcation defect assessed with an explorer will be recorded as (Y/N)
Measured: 12 months
Caries assessment
Caries in furcation defect assessed with an explorer will be recorded as (Y/N)
Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Oct 201927 Nov 2023

First posted16 Aug 2019
Study start15 Oct 2019
Primary completion27 Nov 2023
Study completion27 Nov 2023

Why it stopped: Recruitment problem

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.
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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 5 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04059445
Sponsor's protocol ID: FURC-II-REGEN
Acronym: FURC-II-REGEN
Status last verified: Nov 2023
First submitted: 9 Jul 2019
Last updated: 30 Nov 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
Treatment of Class II Mandibular Furcation Defects
Class II Furcation Defect
Recruiting
Injectable Platelet-Rich Fibrin With Minimally Invasive Non-Surgical Technique in Treatment of Grade II Furcation Defects
Injectable Platelet-Rich Fibrin, Minimally Invasive
Recruiting
Enamel Matrix Derivative and Xenograft for Mandibular Molar Furcation Defects
Class II Furcation Defect
Recruiting
Morphological Characteristics of Mandibular Molar Furcation Involvement and Efficacy of Regenerative Surgical Treatment
Periodontitis, Periodontitis (Stage 3)
Recruiting
Efficacy of PRF and Xenograft in Treating Mandibular Molar Furcation Involvements
Periodontitis, Furcation Defects

All Furcation Defects trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Biphasic Calcium Phosphate and a Collagen Membrane or Biphasic Calcium Phosphate and Enamel Matrix Proteins, in the Regenerative Treatment of Furcation Grade II Defects
ClinicalTrials.gov ID: NCT04059445
Acronym / sponsor ID: FURC-II-REGEN / FURC-II-REGEN
Conditions: Furcation Defects, Periodontal Diseases
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Recruitment problem
Enrolment: 5 participants (actual)
Lead sponsor: University of OsloUniversity, hospital or other
Study start: 15 Oct 2019 (actual)
Primary completion: 27 Nov 2023 (actual)
Study completion: 27 Nov 2023 (actual)
First posted: 16 Aug 2019 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Regenerative therapy w/BCP and collagen membrane	Experimental	Device: Biphasic calcium phosphate (Straumann Bone Ceramic) + collagen membrane (Straumann Jason Membrane), Drug: Biphasic calcium phosphate (Straumann Bone Ceramic) + enamel matrix proteins (Straumann Emdogain)In this arm, treatment of furcation grade II defects includes open flap debridement and regenerative therapy with biphasic calcium phosphate (BCP) and collagen membrane.
Regenerative therapy w/BCP and enamel matrix proteins	Active comparator	Device: Biphasic calcium phosphate (Straumann Bone Ceramic) + collagen membrane (Straumann Jason Membrane), Drug: Biphasic calcium phosphate (Straumann Bone Ceramic) + enamel matrix proteins (Straumann Emdogain)In this arm, treatment of furcation grade II defects includes open flap debridement and regenerative therapy with biphasic calcium phosphate (BCP) and enamel matrix proteins.

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Subject must be ≥ 20 years
Subject must have periodontal disease as determined by the World Workshop 2017 criteria
Subjects must be undergoing periodontal treatment or follow-up and present 1 or more pair of bilateral mandibular molars affected by furcation involvement grade II with PPD >4 mm, and the furcation fornix must be below a tangential line from the distal to mesial interproximal crestal bone level
Competent to give consent

Key exclusion criteria (11 listed)

The following must not be present at the time of enrolment;
Previous radiotherapy to the jaws, current use of chemotherapy, systemic long-term corticosteroid treatment
Present or past use of bisphosphonate treatment
Pregnant or nursing subjects
Patients classified as > class 2 according to the ASA (American Society of Anesthesiologists) physical status classification

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
Biphasic calcium phosphate (Straumann Bone Ceramic) + collagen membrane (Straumann Jason Membrane)Regenerative therapy with biphasic calcium phosphate + collagen membrane.	Device	Regenerative therapy w/BCP and collagen membrane, Regenerative therapy w/BCP and enamel matrix proteins
Biphasic calcium phosphate (Straumann Bone Ceramic) + enamel matrix proteins (Straumann Emdogain)Regenerative therapy with biphasic calcium phosphate + enamel matrix proteins.	Drug	Regenerative therapy w/BCP and collagen membrane, Regenerative therapy w/BCP and enamel matrix proteins

Primary outcome

Change of furcation grade level
Time frame: 12 months after treatment
Proportion of sites demonstrating improvement in furcation grade level as measured with Nabers probe
Change of furcation grade level
Time frame: 24 months after treatment
Proportion of sites demonstrating improvement in furcation grade level as measured with Nabers probe

12 secondary outcomes

Changes in patient-reported quality of life (QoL)
Time frame: Preoperatively compared to 24 months after treatment
Changes in patient-reported quality of life (QoL)
Time frame: Preoperatively compared to 12 months after treatment
Changes in defect morphology assessed by CBCT
Time frame: 24 months after treatment
Changes in CAL
Time frame: 12 months after treatment
Changes in CAL
Time frame: 24 months after treatment
Changes in PPD
Time frame: 12 months after treatment
Changes in PPD
Time frame: 24 months after treatment
Radiographic changes
Time frame: 12 months after treatment
Radiographic changes
Time frame: 24 months after treatment
Pain following surgery
Time frame: Daily for 1 week postoperatively
Caries assessment
Time frame: 12 months
Caries assessment
Time frame: 24 months

Results and safety

The study was stopped early (reason given: Recruitment problem). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.

Related trials for Furcation Defects

RecruitingPhase 3
Treatment of Class II Mandibular Furcation Defects
Class II Furcation Defect
Recruiting
Injectable Platelet-Rich Fibrin With Minimally Invasive Non-Surgical Technique in Treatment of Grade II Furcation Defects
Injectable Platelet-Rich Fibrin, Minimally Invasive
Recruiting
Enamel Matrix Derivative and Xenograft for Mandibular Molar Furcation Defects
Class II Furcation Defect
Recruiting
Morphological Characteristics of Mandibular Molar Furcation Involvement and Efficacy of Regenerative Surgical Treatment
Periodontitis, Periodontitis (Stage 3)
Recruiting
Efficacy of PRF and Xenograft in Treating Mandibular Molar Furcation Involvements
Periodontitis, Furcation Defects

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.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 11 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: stopped early, as of the sponsor's last update on 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Recruitment problem). Results are not available in the source record.

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?

Change of furcation grade level (time frame: 12 months after treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04059445.

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 30 Nov 2023.