Periodontal DiseasePhase 4NCT02474498

EMD and/or Bone Substitute for the Treatment of Class II Furcations

A Phase 4 study testing EMD, βTCP/HA and Flap access surgery in people with Periodontal Disease, run by University of Campinas, Brazil at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Periodontal Disease
What is being tested?: EMD, βTCP/HA and Flap access surgery
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 41 participants
Where: 1 siteBrazil
Study dates: Mar 2013to Jun 2015
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Males and females, between 18-75 years of age;
Presence of a mandibular molar with buccal class-II furcation defect, presenting PD ≥ 4mm, bleeding on probing (BOP), minimum (<1 mm) or no gingival recession after non-surgical therapy;
Good general health;
Minimum interproximal bone loss (< 2 mm).

Who cannot join

Pregnant or lactating;
Required antibiotic pre-medication for the performance of periodontal examination and treatment;
Suffered from any other systemic diseases (cardiovascular, pulmonary, liver, cerebral, diseases or diabetes);
Had received antibiotic treatment in the previous 3 months;
Were taking long-term anti-inflammatory drugs;
Had received a course of periodontal treatment within the last 6 months;
Smokers.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Piracicaba Dental School, State University of Campinas
Piracicaba, São Paulo, 13414-903

Other trials in Brazil

About this study

Official title: Enamel Matrix Protein Derivative and/or Synthetic Bone Substitute for the Treatment of Mandibular Class II Buccal Furcation Defects. A 12-month Randomized Clinical Trial

Read the detailed description

To clinically evaluate the treatment of mandibular class II furcation defects with enamel matrix derivative (EMD) and/or a bone substitute graft make of beta tricalcium phosphate/hydroxyapatite (βTCP/HA). Forty-one patients, presenting a mandibular class II buccal furcation defect, probing pocket depth (PPD) ≥ 4 mm and bleeding on probing, will be included. They will be randomly assigned to the groups: 1- EMD (n = 13); 2- βTCP/HA (n = 14); 3- EMD + βTCP/HA (n = 14). Relative gingival margin position (RGMP), relative vertical and horizontal attachment level (RVCAL and RHCAL) and PPD will be evaluated at baseline and 12 months. The mean horizontal clinical attachment level gain will be considered the primary outcome variable.

Conditions: Periodontal Disease
Being tested: EMD, βTCP/HA, Flap access surgery
Keywords: Regenerative therapy, Randomized clinical trial (RCT), Enamel matrix derivative, Hydroxyapatite-beta tricalcium phosphate, Buccal furcation
Medical subject headings: Periodontal Diseases

What participants receive

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

EMDDrug
Also called Emdogain
During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation defects in this group will receive the application of enamel matrix derivative (EMD - Emdogain® Straumann, Basel, Switzerland).
βTCP/HADevice
Also called Bone Ceramic®
During flap access surgery, the granulation tissue will be removed and the root surfaces were carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a bone substitute consisting of beta tricalcium phosphate/hydroxyapatite (βTCP/HA- Bone Ceramic® Straumann, Basel, Switzerland)
Flap access surgeryProcedure or surgery
In the furcation sites, during flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments.

Study groups in NCT02474498
Study group	Role	What they receive
EMD alone	Active comparator	During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation defects in this group will receive the application of enamel matrix derivative (EMD - Emdogain® Straumann, Basel, Switzerland) and after the flap will be repositioned. Receives: Drug: EMD; Procedure: Flap access surgery
βTCP/HA alone	Active comparator	During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a bone substitute consisting of beta tricalcium phosphate/hydroxyapatite (βTCP/HA- Bone Ceramic® Straumann, Basel, Switzerland) Receives: Device: βTCP/HA; Procedure: Flap access surgery
EMD + βTCP/HA	Active comparator	During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a mixture of enamel matrix derivative proteins (EMD) (Emdogain® Straumann, Basel, Switzerland) and bone substitute consisting of βTCP/HA (Bone Ceramic® Straumann, Basel, Switzerland). Immediately after debridement, EMD will be applied on the root surfaces. The remaining part of the material in the seringe will be then mixed with the bone substitute on a sterile dappen. This mixture will be used to completely fill the defect (EMD + βTCP/HA). Receives: Drug: EMD; Device: βTCP/HA; Procedure: Flap access surgery

What is being measured

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

Relative Horizontal Clinical Attachment Level (RHCAL) at 12 Months
The relative horizontal clinical attachment level (RHCAL) will be measured with the same type of probe (PCP-15 Periodontal Probe - Hu-Friedy - Chicago, IL, USA) as the distance between the deepest point reached by the probe when introduced horizontally into the furcation and the lower border of the stent. This parameter will be evaluated at one specific site at the buccal furcation entrance, determined by a groove made on an individually manufactured acrylic stent and recorded to the nearest 0.5mm.
Measured: 12 months

Secondary outcomes (3)

Relative Vertical Clinical Attachment Level (RVCAL) at 12 Months
The relative vertical clinical attachment level (RVCAL) will be measured with the same type of probe (PCP-15 Periodontal Probe - Hu-Friedy - Chicago, IL, USA) as the distance between the deepest point reached by the probe when introduced vertically into the buccal periodontal pocket. This parameter will be evaluated at one specific site at the buccal furcation entrance, determined by a groove made on an individually manufactured acrylic stent and recorded to the nearest 0.5mm.
Measured: 12 months
Periodontal Probing Depth at 12 Months
Measured: 12 months
Relative Gingival Margin Position (RGMP) at 12 Months
Measured: 12 months

Timeline

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

Mar 2013Jun 2015

First posted17 Jun 2015 (estimated)
Study startMar 2013
Primary completionDec 2014
Study completionJun 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Periodontal DiseaseStudies 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: Single blind
Who is masked: Investigator
Enrolment: 41 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02474498
Sponsor's protocol ID: 035/2007
Status last verified: Jun 2015
First submitted: 10 Jun 2015
Last updated: 20 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: 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

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All Periodontal Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Enamel Matrix Protein Derivative and/or Synthetic Bone Substitute for the Treatment of Mandibular Class II Buccal Furcation Defects. A 12-month Randomized Clinical Trial
ClinicalTrials.gov ID: NCT02474498
Acronym / sponsor ID: 035/2007
Conditions: Periodontal Disease
Keywords: Regenerative therapy, Randomized clinical trial (RCT), Enamel matrix derivative, Hydroxyapatite-beta tricalcium phosphate, Buccal furcation
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 41 participants (actual)
Lead sponsor: University of Campinas, BrazilUniversity, hospital or other
Study start: Mar 2013
Primary completion: Dec 2014 (actual)
Study completion: Jun 2015 (actual)
First posted: 17 Jun 2015 (estimated)
Results: Posted 20 Mar 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 3

Arm	Type	Receives
EMD alone	Active comparator	Drug: EMD, Procedure: Flap access surgeryDuring flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation defects in this group will receive the application of enamel matrix derivative (EMD - Emdogain® Straumann, Basel, Switzerland) and after the flap will be repositioned.
βTCP/HA alone	Active comparator	Device: βTCP/HA, Procedure: Flap access surgeryDuring flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a bone substitute consisting of beta tricalcium phosphate/hydroxyapatite (βTCP/HA- Bone Ceramic® Straumann, Basel, Switzerland)
EMD + βTCP/HA	Active comparator	Drug: EMD, Device: βTCP/HA, Procedure: Flap access surgeryDuring flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a mixture of enamel matrix derivative proteins (EMD) (Emdogain® Straumann, Basel, Switzerland) and bone substitute consisting of βTCP/HA (Bone Ceramic® Straumann, Basel, Switzerland). Immediately after debridement, EMD will be applied on the root surfaces. The remaining part of the material in the seringe will be then mixed with the bone substitute on a sterile dappen. This mixture will be used to completely fill the defect (EMD + βTCP/HA).

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Males and females, between 18-75 years of age;
Presence of a mandibular molar with buccal class-II furcation defect, presenting PD ≥ 4mm, bleeding on probing (BOP), minimum (<1 mm) or no gingival recession after non-surgical therapy;
Good general health;
Minimum interproximal bone loss (< 2 mm).

Key exclusion criteria (7 listed)

Pregnant or lactating;
Required antibiotic pre-medication for the performance of periodontal examination and treatment;
Suffered from any other systemic diseases (cardiovascular, pulmonary, liver, cerebral, diseases or diabetes);
Had received antibiotic treatment in the previous 3 months;
Were taking long-term anti-inflammatory drugs;

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
EMDAlso: EmdogainDuring flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation defects in this group will receive the application of enamel matrix derivative (EMD - Emdogain® Straumann, Basel, Switzerland).	Drug	EMD + βTCP/HA, EMD alone
βTCP/HAAlso: Bone Ceramic®During flap access surgery, the granulation tissue will be removed and the root surfaces were carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a bone substitute consisting of beta tricalcium phosphate/hydroxyapatite (βTCP/HA- Bone Ceramic® Straumann, Basel, Switzerland)	Device	EMD + βTCP/HA, βTCP/HA alone
Flap access surgeryIn the furcation sites, during flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments.	Procedure or surgery	EMD + βTCP/HA, EMD alone, βTCP/HA alone

Primary outcome

Relative Horizontal Clinical Attachment Level (RHCAL) at 12 Months
Time frame: 12 months
The relative horizontal clinical attachment level (RHCAL) will be measured with the same type of probe (PCP-15 Periodontal Probe - Hu-Friedy - Chicago, IL, USA) as the distance between the deepest point reached by the probe when introduced horizontally into the furcation and the lower border of the stent. This parameter will be evaluated at one specific site at the buccal furcation entrance, determined by a groove made on an individually manufactured acrylic stent and recorded to the nearest 0.5mm.

3 secondary outcomes

Relative Vertical Clinical Attachment Level (RVCAL) at 12 Months
Time frame: 12 months
Periodontal Probing Depth at 12 Months
Time frame: 12 months
Relative Gingival Margin Position (RGMP) at 12 Months
Time frame: 12 months

Results and safety

Results posted to the registry on 20 Mar 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
EMD Alone	13	13
βTCP/HA Alone	14	14
EMD + βTCP/HA	14	14

Primary outcome: Relative Horizontal Clinical Attachment Level (RHCAL) at 12 Months

Time frame: 12 months. Mean (Standard Deviation). Unit: mm

Measure	βTCP/HA Alone n = 14	βTCP/HA + EMD n = 14	EMD Alone n = 13
Value	2.31 (0.75)	3.00 (1.04)	2.57 (0.94)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Serious and Other (Not Including Serious) Adverse Events were not collected/assessed. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
βTCP/HA Alone	0 of 0	0 of 0	Not reported
βTCP/HA + EMD	0 of 0	0 of 0	Not reported
EMD Alone	0 of 0	0 of 0	Not reported

Limitations and caveats (from the sponsor): This clinical trial did not show limitations.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Periodontal Disease

Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Recruiting
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Active, not recruitingObservational study
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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.

Enilson A Sallum, PhD principal investigator

University of Campinas, Brazil

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing EMD, βTCP/HA and Flap access surgery in people with Periodontal Disease, run by University of Campinas, Brazil at 1 site in Brazil.

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 7 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 20 Mar 2017. 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 Brazil. 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?

Yes. Results are posted in the registry (first posted 20 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Relative Horizontal Clinical Attachment Level (RHCAL) at 12 Months (time frame: 12 months). 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 NCT02474498.

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 20 Mar 2017.