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PeriodontitisPhase 2NCT04093895

Trial to Evaluate Safety, Tolerability, Efficacy of PerioSept® as Adjunct to SRP in Subjects With Periodontitis

A Phase 2 study testing PerioSept(r) in people with Periodontitis, run by Geistlich Pharma AG at 1 site 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 Phase 2, uncontrolled, open-label, single arm study to evaluate the safety, tolerability and efficacy of PerioSept® (3%) as adjunct to Scaling and Root Planing in subjects with periodontitis. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Periodontitis
What is being tested?
PerioSept(r)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteUnited States
Study dates
26 Aug 2019to 25 Sep 2020
Phase
Phase 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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects male or female 18 to 80 years of age, inclusive.
  • Subjects must be diagnosed with moderate to severe generalized periodontitis (ADA Classification Case Type III or IV) as determined by the investigator.
  • Subjects must have at least 4 qualifying target teeth (having a dental pocket with PPD ≥ 6mm and BOP) (teeth having no endodontic disease - treated or untreated).
  • Subjects must have at least 12 teeth in the functional dentition, excluding second and third molars In subjects with limited dentition, tooth loss should not be due to traumatic occlusion
  • Females of childbearing potential must agree to use of birth control (hormonal, barrier method or abstinence). Hormonal contraceptives must have started not fewer than 30-days before baseline visit/Day 1.
  • Subjects must sign informed consent document(s) prior to initiation of any study-specific procedures and treatments.
  • Subjects who are 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 investigational drug product.
  • Presence of an acute periodontal abscess.
  • Subjects with healing disorders (e.g. uncontrolled diabetes mellitus, oral cancer) that could compromise wound healing and/or preclude periodontal surgery.
  • Subjects who are taking medications that compromise wound healing presenting with clinical evidence of secondary hyperplastic gingival tissue reactions (e.g. calcium channel blockers or anti-seizure medications)
  • Pregnant or nursing female subjects; women of child-bearing potential must have a negative urine pregnancy test.
  • Use of systemic antibiotics and, topically applied oral antibiotics and other antimicrobial agents (e.g., chlorhexidine) within 45 days prior to Day 1 or expected use during the study trial period.
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  • An existing condition that may warrant use of antibiotics during the study trial period.
  • Known Human Immunodeficiency Virus infection or other immunodeficiency syndrome.
  • Subjects with active infectious diseases (e.g. hepatitis, HIV or tuberculosis)
  • Use of agents known to affect periodontal status during the trial and/or use within 45 days prior to Day 1 e.g. immunosuppressants, nasal or oral corticosteroids, calcium channel blockers, phenytoin or anticoagulants.
  • Heavy smokers/tobacco users are excluded: defined as those smoking ≥ 10 cigarettes or ≥ 4 cigars or ≥ 4 pipes per day (smokeless nicotine products are NOT excluded)
  • 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).
  • SRP or periodontal surgery within 12 months prior to Day 1.
  • Subject who have a medical and/or dental condition (e.g. a current clinically unstable occlusal situation) and/or use medications/supplements which the investigator believes makes him/her unsuitable for participation in the study

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Perio Health Professionals

    Houston, Texas, 77063

Other trials in United States

About this study

Official title: A Phase 2 Trial to Evaluate the Safety, Tolerability and Efficacy of PerioSept® (3%) as Adjunct to Scaling and Root Planing in Subjects With Periodontitis

A Phase 2, uncontrolled, open-label, single arm study to evaluate the safety, tolerability and efficacy of PerioSept® (3%) as adjunct to Scaling and Root Planing in subjects with periodontitis.

Read the detailed description

Open-label, uncontrolled, single arm study to evaluate PerioSept® as adjunct to Scaling and Root Planing in Subjects with moderate to severe Periodontitis.

Up to 12 adult subjects will be enrolled to obtain at least 10 evaluable subjects.

4 study visits will take place for each enrolled subject (V1-V4 within 120 days). An additional optional follow-up visit (V5) at 6 Months might be added later on. On the baseline visit at Day 1 (V2) and if needed Day 2 (V2a) patients will undergo full mouth SRP followed by administration of PerioSept® 3% gel into gingival dental pockets. Treatment of PerioSept® 3% (without SRP) will be repeated at V3.

Eligible subjects must have a minimum of 4 qualifying target teeth defined as a tooth with at least one periodontal pocket with a probing pocket depth (PPD) >= 6mm and bleeding on probing (BOP) at baseline defined as study pockets. All study pockets will be treated with SRP and PerioSept®. Additional teeth identified by investigator as needing SRP per standard of care but not meeting target teeth criteria will be defined as non-target teeth/treatment sites and may also be treated with SRP and PerioSept®.

Dental parameters will only be assessed on the target teeth and each of the 6 sites associated with these teeth (assessment sites). Thus, each eligible patient will have at least 4 Target teeth, a minimum of 4 study pockets and a minimum of 24 assessment sites (6 sites per tooth x 4 target teeth, inclusive of the 4 study pockets) that will be assessed for all study outcome measures.

Overall for all 10 evaluable patients there will be at least 40 target teeth, 40 study pockets and 240 sites for which the study outcome measures will be assessed as specified further below.

Assessments will be conducted over a 12 weeks' and optional 24 weeks' (3 and 6 months respectively) period including safety assessments, assessments of dental parameters (PPD, Clinical attachment level, BOP, recession, Plaque index, Gingival Index) and tolerability assessment.

Conditions
Periodontitis
Being tested
PerioSept(r)
Keywords
Periodontitis, taurolidine, PerioSept
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

    Scaling and root planing followed by 3% PerioSept(r) administration

Study groups in NCT04093895
Study groupRoleWhat they receive
SRP and 3% PerioSept(r)ExperimentalScaling and root planing followed by 3% PerioSept® drug administration
Receives: Drug: PerioSept(r)

What is being measured

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

  1. Efficacy: Mean probing pocket depth (PPD) reduction (mm) of all study pockets (pockets with PPD > 6 mm and bleeding on probing (BOP) at baseline on target teeth) at subject level and across all subjects

    Mean probing pocket depth (PPD) reduction (mm) of all study pockets (pockets with PPD > 6 mm and bleeding on probing (BOP) at baseline on target teeth) at subject level and across all subjects

    Measured: Baseline, Week 12

Secondary outcomes (16)

  1. Efficacy: Mean PPD reduction (mm) of all study pockets per patient

    Mean PPD reduction (mm) of all study pockets per patient

    Measured: Baseline, Week 4

  2. Efficacy: Number of study pockets changing from ≥ 6 mm PPD to ≤5 mm PPD

    Number of study pockets changing from ≥ 6 mm PPD to ≤5 mm PPD

    Measured: Baseline; Week 4, 12

  3. Efficacy: Change in Clinical attachment level (CAL) of all study pockets

    Change in CAL of all study pockets

    Measured: Baseline; Week 4, 12

  4. Efficacy: Change in plaque index (PI) of all study pockets

    Change in PI of all study pockets

    Measured: Baseline; Week 4, 12

  5. Efficacy: Change in gingival index (GI) of all study pockets

    Change in GI of all study pockets

    Measured: Baseline; Week 4, 12

  6. Efficacy: Change in BOP of all study pockets

    Change in BOP of all study pockets

    Measured: Baseline; Week 4, 12

  7. Efficacy: Change in recession (REC) of all study pockets

    Change in REC of all study pockets

    Measured: Baseline; Week 4, 12

  8. Efficacy: Change in PPD of all 6 assessment sites on target teeth

    Change in PPD of all 6 assessment sites on target teeth

    Measured: Baseline; Week 4, 12

  9. Efficacy: Change in CAL of all 6 assessment sites on target teeth

    Change in CAL of all 6 assessment sites on target teeth

    Measured: Baseline; Week 4, 12

  10. Efficacy: Change in PI of all 6 assessment sites on target teeth

    Change in PI of all 6 assessment sites on target teeth

    Measured: Baseline; Week 4, 12

  11. Efficacy: Change in GI of all 6 assessment sites on target teeth

    Change in GI of all 6 assessment sites on target teeth

    Measured: Baseline; Week 4, 12

  12. Efficacy: Change in BOP of all 6 assessment sites on target teeth

    Change in BOP of all 6 assessment sites on target teeth

    Measured: Baseline; Week 4, 12

  13. Efficacy: Change in REC of all 6 assessment sites on target teeth

    Change in REC of all 6 assessment sites on target teeth

    Measured: Baseline; Week 4, 12

  14. Safety/tolerability: Assessment of treatment-emergent adverse events based on dental examination

    Assessment of treatment-emergent adverse events based on dental examination

    Measured: Day -45 till Month 6

  15. Tolerability: Clinician assessment of local irritation to include assessments of redness/erythema, inflammation/swelling, blisters or erosions, suppuration and other findings at the study treatment pockets or surrounding tissue.

    Clinician assessment of local irritation to include assessments of redness/erythema, inflammation/swelling, blisters or erosions, suppuration and other findings at the study treatment pockets or surrounding tissue.

    Measured: Day 1, 2, 28

  16. Tolerability: Subject reported tolerability for pain, burning/stinging, sensitivity and taste based on a numeric rating scale

    Subject reported tolerability for pain, burning/stinging, sensitivity and taste based on a numeric rating scale

    Measured: Day 1, 2, 28

Timeline

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

  1. First posted18 Sep 2019
  2. Study start26 Aug 2019
  3. Primary completion10 Jun 2020
  4. Study completion25 Sep 2020

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
single arm, uncontrolled, open-label
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04093895
Sponsor's protocol ID
PSPD 2
Status last verified
Oct 2020
First submitted
13 Sep 2019
Last updated
19 Oct 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PerioSept(r) in people with Periodontitis, run by Geistlich Pharma AG at 1 site 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 15 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 19 Oct 2020. 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 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. 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 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?

Efficacy: Mean probing pocket depth (PPD) reduction (mm) of all study pockets (pockets with PPD > 6 mm and bleeding on probing (BOP) at baseline on target teeth) at subject level and across all subjects (time frame: Baseline, Week 12). 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 NCT04093895.

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 19 Oct 2020; AzTrials last refreshed its copy on 7 Nov 2026.

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