An open-label single arm human clinical study to investigate the efficacy of an herbal toothpaste(GHT - 12) in reducing Gingivitis (early stage of Periodontal disease) in Diabetic population.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- To assess change from baseline for Modified Gingival Index.
研究概览
简要总结
This is an open-label single arm human clinical study to investigate the efficacy of an herbal toothpaste (GHT - 12) in reducing Gingivitis (early stage of Periodontal disease) in Diabetic population. A total of 72 volunteers with known history of Diabetes Mellitus will be selected. All subjects will receive the intervention for 30 days. Dose and Regimen: Unsupervised, twice-daily brushing (2 minutes per brushing) for four weeks at home; and Supervised single brushing (2 minutes) at the study site during baseline and week-four visits. The Primary Efficacy: To assess change from baseline for Modified Gingival Index. Secondary Safety and efficacy Variables and Tools are as follows:
1. To assess change from baseline for Plaque Index2. To assess change from baseline for Bleeding Index
3. To assess change from baseline for Pocket depth
4. To assess change from baseline for S. mutans count
5. To assess change from baseline in reduction of malodour
6. To assess change from baseline in hypersensitivity
7. To assess change from baseline in teeth whiteness
8. To assess change from baseline in extrinsic stains
9. Subjective perception or Subject satisfaction
10. Product Acceptability Questionnaire
Subjects will be recruited as per Inclusion / Exclusion Criteria and assessed on Day 1, Day 10, Day 20 and Day 30.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 20.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Presence of gingivitis 2.All subjects fulfilled at least one or more of the clinical criteria 3.Controlled diabetes mellitus 4.Having at least 20 teeth 5.Agreement to participate in the study 6.Able and willing to follow all study related instructions.
- •7.Must be willing to give written informed consent and comply with the study procedures.
- •8.Subject’s complete blood count parameters to be within clinically acceptable range by Investigator.
- •9.No history of periodontal therapy or previous use of antibiotics or anti-inflammatory medication within the preceding 1 month.
排除标准
- •1.History of hypersensitivity reaction 2.Smoking/ consuming Betel nut/Pan/ Beeda 3.Systemic diseases (Kidney, liver or rheumatologic diseases) 4.To have a pocket depth of more than 5mm 5.Consumption of antibiotics, corticosteroids or nonsteroidal anti-inflammatory drugs in the past 1month and during the study period 6.Subjects with known allergies to the constituents of the formulation 7.Subjects with uncontrolled Hypertension, endocrinal, metabolic disorders excluding diabetes mellitus, underlying heart conditions and other uncontrolled systemic disorders 8.Pregnant and lactating females 9.Subjects undergoing orthodontic treatment 10.Any condition that in the opinion of the investigator does not justify the subject’s inclusion for the study.
结局指标
主要结局
To assess change from baseline for Modified Gingival Index.
时间窗: Day 1, Day 10, Day 20, Day 30.
次要结局
- 1. To assess change from baseline for Plaque(Index)