Periodontitis Clinical Trial
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
Verified date | October 2020 |
Source | Geistlich Pharma AG |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 12 |
Est. completion date | September 25, 2020 |
Est. primary completion date | June 10, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Perio Health Professionals | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Geistlich Pharma AG |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Exploratory: Clinician reported outcome for delivery device handling and ease of use | Clinician reported outcome for delivery device handling and ease of use | Day 1, 2 | |
Other | 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 | Baseline (before treatment); Week 4, 12 | |
Primary | 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 | Baseline, Week 12 | |
Secondary | Efficacy: Mean PPD reduction (mm) of all study pockets per patient | Mean PPD reduction (mm) of all study pockets per patient | Baseline, Week 4 | |
Secondary | 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 | Baseline; Week 4, 12 | |
Secondary | Efficacy: Change in Clinical attachment level (CAL) of all study pockets | Change in CAL of all study pockets | Baseline; Week 4, 12 | |
Secondary | Efficacy: Change in plaque index (PI) of all study pockets | Change in PI of all study pockets | Baseline; Week 4, 12 | |
Secondary | Efficacy: Change in gingival index (GI) of all study pockets | Change in GI of all study pockets | Baseline; Week 4, 12 | |
Secondary | Efficacy: Change in BOP of all study pockets | Change in BOP of all study pockets | Baseline; Week 4, 12 | |
Secondary | Efficacy: Change in recession (REC) of all study pockets | Change in REC of all study pockets | Baseline; Week 4, 12 | |
Secondary | Efficacy: Change in PPD of all 6 assessment sites on target teeth | Change in PPD of all 6 assessment sites on target teeth | Baseline; Week 4, 12 | |
Secondary | Efficacy: Change in CAL of all 6 assessment sites on target teeth | Change in CAL of all 6 assessment sites on target teeth | Baseline; Week 4, 12 | |
Secondary | Efficacy: Change in PI of all 6 assessment sites on target teeth | Change in PI of all 6 assessment sites on target teeth | Baseline; Week 4, 12 | |
Secondary | Efficacy: Change in GI of all 6 assessment sites on target teeth | Change in GI of all 6 assessment sites on target teeth | Baseline; Week 4, 12 | |
Secondary | Efficacy: Change in BOP of all 6 assessment sites on target teeth | Change in BOP of all 6 assessment sites on target teeth | Baseline; Week 4, 12 | |
Secondary | Efficacy: Change in REC of all 6 assessment sites on target teeth | Change in REC of all 6 assessment sites on target teeth | Baseline; Week 4, 12 | |
Secondary | Safety/tolerability: Assessment of treatment-emergent adverse events based on dental examination | Assessment of treatment-emergent adverse events based on dental examination | Day -45 till Month 6 | |
Secondary | 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. | Day 1, 2, 28 | |
Secondary | 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 | Day 1, 2, 28 |
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