CTRI/2024/10/075020尚未招募不适用
Clinical Procedures for Training and Calibration in the Use of the Tooth Stain and Color Indices
Colgate-Palmolive1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年10月14日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Inter and intra examiner reproducibility
研究概览
简要总结
The study titled, "Clinical Procedures for Training and Calibration in the Use of the Tooth Stain and Color Indices" is a single-centered observational study that will be conducted at the Colgate Clinical Innovation Institute, India Global Technology Center of Colgate-Palmolive (India) Limited in Mumbai, India. The study aims to enroll 20 healthy subjects in the age group of 18-70 years with tooth stains for training and calibration of dental examiners for future clinical research studies.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Signed Informed Consent Form.
- •Male and female subjects aged 18-70 years, inclusive.
- •Good general health and good oral health.
- •Availability for the duration of the study.
- •Present twelve (12) scorable natural anterior teeth (free of large restorations or prosthetics).
- •A minimum mean Composite Lobene Index score of 1 or greater.
- •Clinical evidence of a tendency to form extrinsic stains on anterior teeth.
排除标准
- •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).
- •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
Inter and intra examiner reproducibility
时间窗: Inter examiner reproducibility - Visit 1 and 2 | Intra examiner reproducibility - Visit 3 and 4
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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