A Multicenter, Open Label, Randomized, Clinical Study to evaluate and Compare the Efficacy and Safety of Gingivial Paste (Periocream) and Brushing Solution manufactured by Bonyf AG as an adjunct to scaling and roots planning (SRP) with SRP alone in subjects suffering from chronic periodontitis.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- •Tolerance based on clinical dermatological and dental criteria of the paste and tablets (irritation to mucus membrane)
研究概览
简要总结
A Multicenter, Open Label, Randomized, Clinical Study To Evaluate and Compare The Efficacy And Safety of Gingivial paste (Periocream) and brushing solution an adjunct to scaling and roots planning (SRP) with SRP alone in subjects suffering from chronic periodontitis. Gingival paste composed of Calcium/ Sodium PVM/MA copolymer and Olive Oil is applied once time as a coating over infected or healthy gums for 2-3 hours directly after treatment following SRP treatment. On next day 10 effervescent brushing tablets and container given to subjects along with instruction sheet with which subject have to brush their teeth. Clinical periodontal parameter & Clinical Performance parameter will be checked before and after treatment. Also Subgingingival plaque will be collected, pre and post treatment, for total bacterial count and analysis of four major periodontopathogenic bacteria. Data will be compare with control group subject who only had SRP treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 30.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male or female subjects with 30-50 years of age (both inclusive).
- •2.Subjects suffering from chronic periodontitis and required medical device after scaling and root planning (SRP) in Non-chirurgical procedures.
- •3.Negative history of any systemic disease.
- •4.Willingness to comply with the study schedule and procedures.
排除标准
- •1.Subjects with a history of allergy for content present in “PerioCreamâ€.
- •2.Subjects with Mobile, carious, endodontically treated teeth.
- •3.History of chronic liver disease, chronic renal disease, diabetic, Hyperthyroidism, severe anaemia, severe myasthenia, Active haemorrhage, Acute alcohol intoxication, Recent myocardial infarction).
- •4.Smokers and Tobacco users.
- •5.Subjects using any chemical plaque inhibitors.
- •6.Subjects suffering from condition requiring antibiotics prior to dental procedures or currently using antibiotics, anticoagulants, steroids, or any other medication which could alter the oral microflora.
- •7.Participation in any other clinical study during last 30 days.
- •8.Subject with any condition which in the opinion of the investigator makes the subject unsuitable for inclusion.
- •9.Subject is a female who is pregnant or willing to get pregnant, not ready to use contraceptive measures during the trial period, or is breast feeding.
结局指标
主要结局
•Tolerance based on clinical dermatological and dental criteria of the paste and tablets (irritation to mucus membrane)
时间窗: 10 days
•Efficacy of brushing small tabs (considering oral Hygiene product) by determining Plaque index, gingival index, periodontal bleeding index and clinical attachment level.
时间窗: 10 days
•Total bacterial count and analysis (before and after treatment with periocream)
时间窗: 10 days
•Evaluation will be done on bases of questionnaire.
时间窗: 10 days
次要结局
- Spontaneously reported and directly observed Adverse Events after first dose until End of treatment visit.(10 Days)