NCT05188924Unknown4 期
A Multi-center, Randomized, Double-blinded, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of DKF-306 in Patients With Periodontal Diseases
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 158
- 试验地点
- 1
- 主要终点
- Change in gingival index from baseline to Week 12
研究概览
简要总结
This is a multi-center, randomized, double-blinded, placebo-controlled study to evaluated the efficacy and safety of DKF-306 in patients with periodontal diseases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 19 years and older
- •Periodontal diseases
- •Having not less than 16 permanent teeth including at least 4 molars (third molars excluded)
- •Having teeth with not less than 2 sites of both probing pocket depth (PPD) ≥ 4 mm and gingival index (GI) ≥ 2 in at least 2 quadrants
- •Agrees not to use over-the-counters (oral, ointment, toothpaste, film, etc.) or quasi-drugs (gargle and mouthwash) to alleviate or treat the symptoms of gingivitis or periodontitis during the study
- •Voluntarily signed the informed consent form
- •Willing to participate in the study
排除标准
- •Hypersensitivity to ingredients of investigational products
- •Hypersensitivity to Azo dyes, acetylsalicylic acid or other prostaglandin synthase inhibitors
- •Following diseases or state in the mouth:
- •rampant caries or decayed tooth/teeth remained untreated for a long time
- •multiple restorations which may be related to periodontal inflammation
- •poor oral hygiene with heavy plaque or calculus deposition
- •soft or hard tissue tumor
- •systemic chronic diseases with oral manifestations
- •fibrotic gingival enlargement
- •Use of orthodontic appliances or removable partial denture(s)
- •Having teeth or state in need of immediate treatment such as periodontal abscess, a tooth indicated for extraction, etc.
- •History of aggressive periodontitis or acute necrotizing ulcerative gingivitis
- •Received dental treatments such as endodontic treatments or periodontal therapy (including both nonsurgical and surgical therapy) within 3 months from randomization
- •Received the following drugs for more than 2 weeks within 3 months from randomization:
- •systemic/local antibiotics in the mouth or non-steroidal anti-inflammatory drugs
- •cyclosporine or corticosteroids
- •phenytoin, calcium antagonists, anticoagulants or antiplatelets
- •Initiated drugs in treatment of chronic diseases within 3 months from randomization
- •Received the same drug with investigational products within 3 months from randomization
- •Medical conditions or diseases affecting the efficacy and safety of investigational products at the investigator's discretion
- •Heavy smoker (20 cigarettes or more a day)
- •Pregnant or breast-feeding
- •Plans to have a child or unwilling to comply with using medically accepted contraception methods during the study
- •Alcohol or drug abuse
- •Other investigational products or procedures within 3 months from screening
- •Not eligible due to other reasons at the investigator's discretion
研究组 & 干预措施
DKF-306
Experimental
During Weeks 1 to 4, 2 tablets, t.i.d. During Weeks 5 to 12, 1 tablet, t.i.d.
干预措施: DKF-306 (Drug)
Placebo
Placebo Comparator
During Weeks 1 to 4, 2 tablets, t.i.d. During Weeks 5 to 12, 1 tablet, t.i.d.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in gingival index from baseline to Week 12
时间窗: Weeks 0 and 12
次要结局
- Change in gingival index from baseline to Weeks 4 and 8(Weeks 0, 4 and 8)
- Change in bleeding on probing (%) from baseline to Weeks 4, 8 and 12(Weeks 0, 4, 8 and 12)
- Change in plaque index from baseline to Weeks 4, 8 and 12(Weeks 0, 4, 8 and 12)
- Change in probing pocket depth from baseline to Weeks 4, 8 and 12(Weeks 0, 4, 8 and 12)
- Change in clinical attachment level from baseline to Weeks 4, 8 and 12(Weeks 0, 4, 8 and 12)
研究者
研究点 (1)
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