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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- •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
- •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
- •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
研究组 & 干预措施
SRP and 3% PerioSept(r)
Scaling and root planing followed by 3% PerioSept® drug administration
干预措施: PerioSept(r) (Drug)
结局指标
主要结局
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
时间窗: 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
次要结局
- Efficacy: Mean PPD reduction (mm) of all study pockets per patient(Baseline, Week 4)
- Efficacy: Number of study pockets changing from ≥ 6 mm PPD to ≤5 mm PPD(Baseline; Week 4, 12)
- Efficacy: Change in Clinical attachment level (CAL) of all study pockets(Baseline; Week 4, 12)
- Efficacy: Change in plaque index (PI) of all study pockets(Baseline; Week 4, 12)
- Efficacy: Change in gingival index (GI) of all study pockets(Baseline; Week 4, 12)
- Efficacy: Change in BOP of all study pockets(Baseline; Week 4, 12)
- Efficacy: Change in recession (REC) of all study pockets(Baseline; Week 4, 12)
- Efficacy: Change in PPD of all 6 assessment sites on target teeth(Baseline; Week 4, 12)
- Efficacy: Change in CAL of all 6 assessment sites on target teeth(Baseline; Week 4, 12)
- Efficacy: Change in PI of all 6 assessment sites on target teeth(Baseline; Week 4, 12)
- Efficacy: Change in GI of all 6 assessment sites on target teeth(Baseline; Week 4, 12)
- Efficacy: Change in BOP of all 6 assessment sites on target teeth(Baseline; Week 4, 12)
- Efficacy: Change in REC of all 6 assessment sites on target teeth(Baseline; Week 4, 12)
- Safety/tolerability: Assessment of treatment-emergent adverse events based on dental examination(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.(Day 1, 2, 28)
- Tolerability: Subject reported tolerability for pain, burning/stinging, sensitivity and taste based on a numeric rating scale(Day 1, 2, 28)