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PeriodontitisPhase 1/2NCT02313883

A Phase I/II Study to Evaluate the Safety and Efficacy of PerioSept® as Adjunct to SRP in Subjects With Periodontitis

A Phase 1/2 study testing PerioSept(r) in people with Periodontitis, run by Geistlich Pharma AG at 4 sites in United States.

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

A Pharmacokinetic Pilot followed by a Phase I/II, Blinded, Randomized, Controlled, Parallel Arm Trial to Evaluate the Safety, Tolerability and Efficacy of PerioSept® and Scaling and Root Planing in Subjects with Periodontitis Read more about this study

Who is it for?
Ages 18 to 74 yearsHealthy volunteers can take part
Conditions the study is for
Periodontitis
What is being tested?
PerioSept(r)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
127 participants
Where
4 sitesUnited States
Study dates
Jul 2015to 2 Jul 2018
Phase
Phase 1/2
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 to 74 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 18 to 74 years of age, inclusive
  • Diagnosed with moderate to severe generalized periodontitis (ADA Classification Case Type III or IV)
  • Must have at least 4 qualifying Study Pockets (PPD ≥ 5mm and BOP) in at least 2 quadrants (main trial)
  • Subjects must sign informed consent document(s) prior to initiation of any study-specific procedures and treatments
  • Agree to utilize study-provided tooth paste and tooth brush and agree to follow their standard oral hygiene routine with limitations noted below from the Day 1 visit through the end of the study
  • Sexually active subjects (both men and women) who agree to use acceptable contraceptive methods for the duration of the study
  • Able and willing to adhere to the study visit schedule and other protocol requirements

Who cannot join

  • History of and/or known risk of life-threatening anaphylactic reactions to taurolidine, any of the components in the PS drug product, and other drugs or agonists (e.g., penicillin, nuts, insect stings)
  • Presence of an acute periodontal abscess
  • Known endodontic disease
  • Diabetes uncontrolled by medication defined as fasting blood glucose documented at ≥200 mg/dL within 90 days of Day 1
  • History of illegal drug or alcohol abuse within the past 12 months and/or testing positive for illegal drugs (including marijuana) at the Screening Visit
  • Pregnant or nursing female subjects; women of child-bearing potential must have a negative serum or urine pregnancy test within 30 days and within 24 h prior to all treatment/dosing days
Show all 19Show fewer
  • Use of systemic antibiotics and topically applied oral antibiotics and other antimicrobial agents (e.g., chlorhexidine) during the trial and within 30 days of Day 1.
  • An existing condition that may warrant use of antibiotics during the trial (e.g., white blood cell count indicative of ongoing infection noted at Screening Visit, subject with cystic fibrosis or chronic obstructive pulmonary disorder with history of frequent, recurrent lung infections)
  • History of and/or testing positive for Hepatitis B or C, Human Immunodeficiency Virus or other immunedeficiency syndrome or positive test for such at Screening Visit
  • Use of chewing gum of any kind and dental flossing for one week after all study treatments and use of any other oral dentifrices or oral health agents/treatments other than those provided herein for the study duration
  • Use within 30 days prior to Day 1, during trial or a condition for which use is anticipated during trial: topical oral, nasal and systemic corticosteroids, chronic (2 continuous weeks) non-steroidal anti-inflammatory drugs (NSAIDs)
  • Use of the agents known to affect periodontal status during the trial and/or use within 30 days prior to Day 1: immunesuppressants, calcium antagonist, phenytoin or anticoagulants
  • Heavy smokers/tobacco users are excluded: defined as those smoking ≥ 10 cigarettes or ≥ 4 cigars or ≥ 4 pipes per day
  • For non-heavy smokers, smoking ≥ 10 cigarettes or ≥ 4 cigars or ≥ 4 pipes per day is prohibited for the duration of the trial
  • Use of electronic/smokeless and herbal cigarettes/pipes and oral smokeless/chewing tobacco within 30 days of Day 1 excluded and all use of these products is prohibited during trial
  • Clinically significant (e.g., QTc interval >450 milliseconds) abnormal electrocardiogram (ECG) noted at Screening Visit
  • Participation in another clinical study with an investigational agent within 90 days prior to Day 1
  • Subjects who received oral health treatments/interventions within 90 days of Day 1, which the investigator believes may interfere with the periodontal parameters to be assessed in this study (e.g., significant dental and/or gum/oral tissue work).
  • Subject has a medical and/or dental condition and/or uses medications/supplements which the investigator believes makes him/her unsuitable for participation in the study

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • University of Michigan School of Dentistry

    Ann Arbor, Michigan, 48109

  • Regenerative solutions

    Fullerton, California, 92835

  • Perio Health Professionals

    Houston, Texas, 77063

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: A Phase I/II Study to Evaluate the Safety, Tolerability and Efficacy of PerioSept® and Scaling and Root Planing in Subjects With Periodontitis

A Pharmacokinetic Pilot followed by a Phase I/II, Blinded, Randomized, Controlled, Parallel Arm Trial to Evaluate the Safety, Tolerability and Efficacy of PerioSept® and Scaling and Root Planing in Subjects with Periodontitis

Read the detailed description

This trial will follow an adaptive trial design, whereby information regarding PerioSept(r) drug levels will be obtained via a PK trial lead in period (PK Pilot) in a limited number of subjects (up to N=8). This will be followed by the main safety and efficacy trial of PerioSept(r) as an adjunct to scaling and root planing (SRP) in subjects with moderate to severe periodontitis (Main Trial, N=87). The PK Pilot will be an open label PK study. Up to 8 qualifying subjects will receive SRP on Day 1 followed by 3% PerioSept(r) administered in a minimum of 4 qualifying periodontal Study Pockets in at least 2 quadrants with a probing pocket depth (PPD) ≥ 5mm and bleeding on probing (BOP) and at least 20 other qualifying pockets (PPD ≥ 5 mm). The Main Trial will be a multi-center, randomized, blinded, placebo controlled, parallel arm trial of PerioSept(r) (0.3%, 1% or 3%) administered up to three times (over Days 1 and 2, at Weeks 4 and 12) into a minimum of 4 qualifying periodontal Study Pockets in at least 2 quadrants with a PPD ≥ 5mm and BOP following SRP at baseline. All other eligible pockets with a PPD ≥ 5mm will also be treated.

Full mouth SRP will be initiated on Day 1 followed by randomized treatment of that side. If necessary, SRP and randomized treatment may be completed on the other side of the mouth on Day 2. Treated pockets that still have a PPD ≥ 5mm at the 4 and 12 week visits will be retreated with SRP or SRP plus placebo or PS, as randomized. Assessments will be conducted over a 24 week (6 month) period including safety assessments and assessments of dental parameters (PPD, BOP, Plaque index, Gingival Index, Clinical attachment level).

Conditions
Periodontitis
Being tested
PerioSept(r)
Keywords
periodontitis, taurolidine (PerioSept(r)), scaling and root planing
Medical subject headings
Periodontitis

What participants receive

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

  • PerioSept(r)Drug

    Also called Taurolidine

    Taurolidine is derived from the amino acid taurine and has antimicrobial and immune modulating properties

Study groups in NCT02313883
Study groupRoleWhat they receive
SRP onlyPlacebo comparatorScaling and root planing only
Receives: Drug: PerioSept(r)
SRP and PlaceboPlacebo comparatorScaling and root planing followed by placebo drug administration
Receives: Drug: PerioSept(r)
SRP and 0.3% PerioSept(r)ExperimentalScaling and root planing followed by 0.3% PerioSept(r) drug administration
Receives: Drug: PerioSept(r)
SRP and 1 % PerioSept(r)ExperimentalScaling and root planing followed by 1% PerioSept(r) drug administration
Receives: Drug: PerioSept(r)
SRP and 3% PerioSept(r)ExperimentalScaling and root planing followed by 3% PerioSept(r) drug administration
Receives: Drug: PerioSept(r)

What is being measured

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

  1. Safety and Tolerability:Hematology safety labs, Chem 14, urine analysis, ECG, treatment emergent adverse events, local irritation, patient reported pain, sensisitivity, burning stinging

    Hematology safety labs, Chem 14, urine analysis, ECG, treatment emergent adverse events, local irritation, patient reported pain, sensisitivity, burning stinging

    Measured: 6 months

  2. Efficacy: Reduction in probing pocket depth (PPD)

    Reduction in probing pocket depth (PPD)

    Measured: 6 months

Secondary outcomes (4)

  1. Efficacy REC and CAL: Changes from baseline in Recession (REC)/Clinical attachment level (CAL)

    Changes from baseline in Recession (REC)/Clinical attachment level (CAL)

    Measured: 6 months

  2. Efficacy BOP: Presence or absence of bleeding on probing (BOP)

    Presence or absence of bleeding on probing (BOP)

    Measured: 6 months

  3. Efficacy PI: Changes from baseline in Plaque index

    Changes from baseline in Plaque index

    Measured: 6 months

  4. Efficacy GI: Changes from baseline in Gingival index

    Changes from baseline in Gingival index

    Measured: 6 months

Timeline

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

  1. First posted10 Dec 2014 (estimated)
  2. Study startJul 2015
  3. Primary completion2 Jul 2018
  4. Study completion2 Jul 2018

Resources

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
127 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02313883
Sponsor's protocol ID
PSPD 1-2
Status last verified
Sep 2019
First submitted
8 Dec 2014
Last updated
17 Sep 2019
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing PerioSept(r) in people with Periodontitis, run by Geistlich Pharma AG at 4 sites in United States.

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 7 inclusion and 19 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 17 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 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?

Safety and Tolerability:Hematology safety labs, Chem 14, urine analysis, ECG, treatment emergent adverse events, local irritation, patient reported pain, sensisitivity, burning stinging (time frame: 6 months). 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 NCT02313883.

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 17 Sep 2019.

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