CClinicalTrials.gg
Sign In
CompletedNCT04093895Updated Oct 19, 2020

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

A Phase 2 interventional study of PerioSept(r) in Periodontitis, sponsored by Geistlich Pharma AG. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-10-19.

Sponsored by Geistlich Pharma AG · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Jun 2020, 6 years 3 months ago, and no results have been posted to the registry.
Phase
Phase 2
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Periodontitis

Browse trials for

Keywords

  • Periodontitis
  • taurolidine
  • PerioSept
03

In context

Periodontitis

1,635 studies on the registry are indexed under Periodontitis; 327 are open to participants now.

This study's enrollment of 12 is below the median of 45 across 1,191 interventional studies indexed under Periodontitis.

Browse Periodontitis studies →

Lead sponsor

Geistlich Pharma AG is the lead sponsor of 13 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    SRP and 3% PerioSept(r)

    Scaling and root planing followed by 3% PerioSept® drug administration

    Drug: PerioSept(r)

Interventions

  • DrugPerioSept(r)

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

    Also known as: Taurolidine

06

What researchers measure

Primary outcomes

  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

    Time frame: Baseline, Week 12

Secondary outcomes

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

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

    Time frame: 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

    Time frame: Baseline; Week 4, 12

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

    Change in CAL of all study pockets

    Time frame: Baseline; Week 4, 12

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

    Change in PI of all study pockets

    Time frame: Baseline; Week 4, 12

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

    Change in GI of all study pockets

    Time frame: Baseline; Week 4, 12

  6. Efficacy: Change in BOP of all study pockets

    Change in BOP of all study pockets

    Time frame: Baseline; Week 4, 12

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

    Change in REC of all study pockets

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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.

    Time frame: 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

    Time frame: Day 1, 2, 28

Other outcomes

  1. Exploratory: Clinician reported outcome for delivery device handling and ease of use

    Clinician reported outcome for delivery device handling and ease of use

    Time frame: Day 1, 2

  2. Exploratory: Microbiological counts of periodontal pathogens in biofilm samples of 4 study pockets

    Microbiological counts of periodontal pathogens in biofilm samples of 4 study pockets

    Time frame: Baseline (before treatment); Week 4, 12

07

Study locations

1 site
  • Perio Health Professionals
    Houston, Texas 77063, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 19, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04093895
Lead sponsor
Geistlich Pharma AG
Responsible party
Sponsor
First posted
Sep 18, 2019
Start date
Aug 26, 2019
Primary completion
Jun 10, 2020
Completion
Sep 25, 2020
Last update
Oct 19, 2020

Study contacts

Michael McGuire, DDS
principal investigator · PerioHealth Clinic Houston

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Periodontitis→

Other studies from this sponsor

Geistlich Pharma AG

Start the discussion