CTRI/2024/11/076685尚未招募4 期
Proof-of-concept clinical study to evaluate the stain removal efficacy of a commercially available as compared to negative control toothpaste
Colgate-Palmolive1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年11月16日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Changes in Tooth stain determined by examiner use Lobene Stain
研究概览
简要总结
This is a proof-of-concept clinical study to evaluate the stain removal efficacy of a commercially available toothpaste as compared to negative control toothpaste. Thirty (30) subjects, aged 18-70 years, inclusive, will be entered into the study. Candidates who have expressed an interest in participating will be selected based on the inclusion and exclusion criteria. This is a Phase IV, single-center, two cell, parallel-group and double-blinded clinical study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Potential subjects must meet ALL of the following criteria: Signed Informed Consent Form; Male and female subjects aged 18-70 years, inclusive; Good general health and good oral health based on the opinion of the study investigator; Present twelve (12) scorable natural anterior teeth (free of large restorations or prosthetics).
- •Availability for the duration of the study; Self reported consumption of tea, coffee or tobacco ≥ 2 times a day.
- •A minimum mean Composite Lobene Index score of 1 or greater.
- •Clinical evidence of a tendency to form stains on anterior teeth.
排除标准
- •Potential subjects must NOT HAVE ANY of the following conditions: Presence of orthodontic appliances or any anterior tooth with a prosthetic crown or veneer.
- •Presence of partial removable dentures.
- •Tumors or significant pathology of the soft or hard tissues of the oral cavity.
- •Presence of anterior teeth with severe or atypical staining, which include tetracycline or hypo-calcification.
- •Use of antibiotics or stain inducing medications any time during the one month prior to entry into the study.
- •Dental prophylaxis received in the past four weeks prior to baseline examinations or usage of whitening toothpaste.
- •History of alcohol or drug abuse.
- •Exposed to a tooth whitening procedure during the last 3 months.
- •Moderate periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone) or any other condition that the dental examiner considers would exclude you from participation.
- •Five or more carious lesions requiring immediate restorative treatment.
- •History of allergy to consumer or personal care products as determined by the dental professional monitoring the study.
- •Participation in any other clinical study or test panel within the 30-day period prior to entering into the study.
- •Pregnant women or women who are breast-feeding.
- •Medical conditions that the investigator considers significant which may compromise the subject’s safety as well as the quality of the study results.
- •Restorations on the teeth to be scored which may interfere with scoring procedures.
结局指标
主要结局
Changes in Tooth stain determined by examiner use Lobene Stain
时间窗: Baseline, 7 days and 14 days
次要结局
- N/A(N/A)
研究者
Dr Bhuvana Gurumurthy
Colgate-Palmolive India Limited
研究点 (1)
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