CTRI/2024/12/077856已完成不适用
An open label, prospective, multicenter, comparative, randomized, controlled, 2-arm study to assess the safety and efficacy of Zn citrate based Dental Gel in subjects with periodontitis / gingivitis.
Dr. Reddys Laboratories Ltd.2 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2024年12月27日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Comparison of reduction in gingivitis assessed using gingival index between 2 products.
研究概览
简要总结
This is an open label, prospective, prospective, multicenter, comparative, randomized, controlled, 2-arm study to assess the safety and efficacy of Stolin-R Toothpaste in subjects with periodontitis / gingivitis.
The potential subjects will be screened as per the inclusion and exclusion criteria only after obtaining written informed consent from the subjects.
Subjects will be divided into 04 groups.
Group 1a: Healthy Subjects using Test Product (Zn citrate based Dental Gel)
Group 1b: Healthy Subjects using Comparator Product (Colgate Strong Teeth)
Group 2a: Subjects with Type 2 Diabetes Mellitus using Test Product (Zn citrate based Dental Gel)
Group 2b: Subjects with Type 2 Diabetes Mellitus using Comparator Product (Colgate Strong Teeth)
All eligible subjects will undergo dental assessment and subjective evaluation. Safety will be assessed throughout the study by monitoring adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
入选标准
- •Age: 18 to 60 years (both inclusive) at the time of consent.
- •Gender: Males and Non-pregnant /Non-Lactating females.
- •For Group 1: a.
- •Healthy subjects as determined by the Investigator based on medical history and vital signs.
- •AND For Group 2: a.
- •Subjects with Type 2 Diabetes Mellitus, reported HbA1c level between 6.5 to 8 in past 3 months.
- •Subjects with physician diagnosed type 2 diabetes of more than three months duration and who are currently under the care of a physician for diabetes management.
- •Subjects with moderate to severe (3 to 4) plaque as determined by Plaque Index System.
- •Subjects with mild to moderate (1 to 2) gingivitis/periodontitis.
- •Subjects having slight to strong oral malodor / bad breath (2 to 4) associated with periodontal disease as determined by Organoleptic Scoring Scale.
- •Subjects who are willing to come to the test site without brushing their teeth in the morning of visit 01 [Screening, Enrollment and Baseline Visit (Day 01)].
- •Subjects who are willing to participate in the study and give a signed consent.
- •Subjects should be willing and able to follow the study protocol to participate in the study.
排除标准
- •Pregnant or breastfeeding or planning pregnancy during the study period.
- •Subjects not willing to follow all the acceptable forms of contraception as applicable.
- •Subjects with orthodontic bands and partial removable dentures.
- •Subjects having tumor(s) of the soft or hard tissues of the oral cavity.
- •Subject with advanced periodontal disease (purulent exudate, tooth mobility with grade 3, and/or extensive loss of periodontal attachment or alveolar bone).
- •Subjects having history of acute cardiac and circulatory diseases, HIV, hepatitis, uncontrolled hypertension and Hyperthyroidism.
- •Subjects who are receiving chronic treatment with systemic corticosteroids, cyclosporine or other systemic immunosuppressive drugs.
- •Subjects who are undergoing chronic treatment with systemic antibiotics 9) Subjects who are currently receiving dialysis.
- •Subjects who are at increased risk of bleeding complications from dental treatment, based on medical history.
- •Subjects who require Essential Dental Care (e.g., treatment for grossly decayed teeth, broken teeth, dental abscesses, peri-apical infections, other dental infections, extractions, impactions, implant placement, irreversible pulpitis, surgical removal of cysts and tumors, mucositis due to radiotherapy/chemotherapy).
- •Heavy alcohol consumption (on average more than 2 drinks/day for women and more than 3 drinks/day for men).
- •Subjects smoking cigarette or consume any other form of tobacco.
- •Participation in a similar clinical study within the previous 30 Days.
- •Any other condition which could warrant exclusion from the study, as per the investigator’s discretion.
结局指标
主要结局
Comparison of reduction in gingivitis assessed using gingival index between 2 products.
时间窗: Day 30 (+ 02 days)
次要结局
- Assessment of gingivitis assessed using gingival index(Day 01, Day 07, Day 15 and Day 30 and Day 60)
- Assessment of plaque formation using plaque index and disclosing agent(Day 01, Day 07, Day 15 and Day 30 and Day 60)
- Assessment of pocket depth or clinical level attachment using a periodontal probe(Day 01, Day 07, Day 15 and Day 30 and Day 60)
- Assessment of bleeding gums using WHO probe(Day 01, Day 07, Day 15 and Day 30 and Day 60)
- Assessment of halitosis using Organoleptic Scoring Scale.(Day 01, Day 07, Day 15 and Day 30 and Day 60)
- Assessment of overall gum health by dental examination(Day 01, Day 07, Day 15 and Day 30 and Day 60)
- Subjective questionnaires(Day 01, Day 07, Day 15 and Day 30 and Day 60)
研究者
Dr Parth Joshi
Cliantha Research
研究点 (2)
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