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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Scaling and root planing followed by 3% PerioSept(r) administration
Perio Health Professionals
Houston, Texas, United States
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
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
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
Efficacy: Change in Clinical attachment level (CAL) of all study pockets
Change in CAL of all study pockets
Time frame: Baseline; Week 4, 12
Efficacy: Change in plaque index (PI) of all study pockets
Change in PI of all study pockets
Time frame: Baseline; Week 4, 12
Efficacy: Change in gingival index (GI) of all study pockets
Change in GI of all study pockets
Time frame: Baseline; Week 4, 12
Efficacy: Change in BOP of all study pockets
Change in BOP of all study pockets
Time frame: Baseline; Week 4, 12
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Efficacy: Change in recession (REC) of all study pockets
Change in REC of all study pockets
Time frame: Baseline; Week 4, 12
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
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
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
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
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
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
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
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
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