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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04093895
Recruitment Status : Active, not recruiting
First Posted : September 18, 2019
Last Update Posted : October 22, 2019
Sponsor:
Information provided by (Responsible Party):
Geistlich Pharma AG

Brief 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.

Condition or disease Intervention/treatment Phase
Periodontitis Drug: PerioSept(r) Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Intervention Model Description: single arm, uncontrolled, open-label
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 26, 2019
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : April 30, 2020

Arm Intervention/treatment
Experimental: SRP and 3% PerioSept(r)
Scaling and root planing followed by 3% PerioSept® drug administration
Drug: PerioSept(r)
Scaling and root planing followed by 3% PerioSept(r) administration
Other Name: Taurolidine




Primary Outcome Measures :
  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 [ Time Frame: Baseline, Week 12 ]
    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


Secondary Outcome Measures :
  1. Efficacy: Mean PPD reduction (mm) of all study pockets per patient [ Time Frame: Baseline, Week 4 ]
    Mean PPD reduction (mm) of all study pockets per patient

  2. Efficacy: Number of study pockets changing from ≥ 6 mm PPD to ≤5 mm PPD [ Time Frame: Baseline; Week 4, 12 ]
    Number of study pockets changing from ≥ 6 mm PPD to ≤5 mm PPD

  3. Efficacy: Change in Clinical attachment level (CAL) of all study pockets [ Time Frame: Baseline; Week 4, 12 ]
    Change in CAL of all study pockets

  4. Efficacy: Change in plaque index (PI) of all study pockets [ Time Frame: Baseline; Week 4, 12 ]
    Change in PI of all study pockets

  5. Efficacy: Change in gingival index (GI) of all study pockets [ Time Frame: Baseline; Week 4, 12 ]
    Change in GI of all study pockets

  6. Efficacy: Change in BOP of all study pockets [ Time Frame: Baseline; Week 4, 12 ]
    Change in BOP of all study pockets

  7. Efficacy: Change in recession (REC) of all study pockets [ Time Frame: Baseline; Week 4, 12 ]
    Change in REC of all study pockets

  8. Efficacy: Change in PPD of all 6 assessment sites on target teeth [ Time Frame: Baseline; Week 4, 12 ]
    Change in PPD of all 6 assessment sites on target teeth

  9. Efficacy: Change in CAL of all 6 assessment sites on target teeth [ Time Frame: Baseline; Week 4, 12 ]
    Change in CAL of all 6 assessment sites on target teeth

  10. Efficacy: Change in PI of all 6 assessment sites on target teeth [ Time Frame: Baseline; Week 4, 12 ]
    Change in PI of all 6 assessment sites on target teeth

  11. Efficacy: Change in GI of all 6 assessment sites on target teeth [ Time Frame: Baseline; Week 4, 12 ]
    Change in GI of all 6 assessment sites on target teeth

  12. Efficacy: Change in BOP of all 6 assessment sites on target teeth [ Time Frame: Baseline; Week 4, 12 ]
    Change in BOP of all 6 assessment sites on target teeth

  13. Efficacy: Change in REC of all 6 assessment sites on target teeth [ Time Frame: Baseline; Week 4, 12 ]
    Change in REC of all 6 assessment sites on target teeth

  14. Safety/tolerability: Assessment of treatment-emergent adverse events based on dental examination [ Time Frame: Day -45 till Month 6 ]
    Assessment of treatment-emergent adverse events based on dental examination

  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. [ Time Frame: Day 1, 2, 28 ]
    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.

  16. Tolerability: Subject reported tolerability for pain, burning/stinging, sensitivity and taste based on a numeric rating scale [ Time Frame: Day 1, 2, 28 ]
    Subject reported tolerability for pain, burning/stinging, sensitivity and taste based on a numeric rating scale


Other Outcome Measures:
  1. Exploratory: Clinician reported outcome for delivery device handling and ease of use [ Time Frame: Day 1, 2 ]
    Clinician reported outcome for delivery device handling and ease of use

  2. Exploratory: Microbiological counts of periodontal pathogens in biofilm samples of 4 study pockets [ Time Frame: Baseline (before treatment); Week 4, 12 ]
    Microbiological counts of periodontal pathogens in biofilm samples of 4 study pockets



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04093895


Locations
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United States, Texas
Perio Health Professionals
Houston, Texas, United States, 77063
Sponsors and Collaborators
Geistlich Pharma AG
Investigators
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Principal Investigator: Michael McGuire, DDS PerioHealth Clinic Houston

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Responsible Party: Geistlich Pharma AG
ClinicalTrials.gov Identifier: NCT04093895    
Other Study ID Numbers: PSPD 2
First Posted: September 18, 2019    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Geistlich Pharma AG:
Periodontitis
taurolidine
PerioSept
Additional relevant MeSH terms:
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Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Taurolidine
Anti-Infective Agents
Anti-Infective Agents, Local
Antineoplastic Agents