A Clinical Study to Evaluate the Teeth Whitening Efficacy and User Feedback of a PAP-Based Teeth Whitening Strip Following Once-Daily Use Over a 14-Day Period in Healthy Adult trial participants
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
研究概览
简要总结
This is a single-center, open-label, baseline-controlled clinical study designed to evaluate the whitening efficacy, safety, and participant-reported outcomes of a PAP-based teeth whitening strip following once-daily use for 14 days. Thirty healthy adults aged 18–50 years will be enrolled. All participants will receive the test product and serve as their own control by comparing post-treatment outcomes with baseline values.
The study includes four visits: Screening/Baseline (Day 0), Day 3, Day 7, and Day 14 (End of Study). Baseline procedures include eligibility screening, informed consent, collection of demographic and medical/dental history, oral soft tissue examination, and tooth shade assessment using a Linear Shade Guide and VITA Easyshade® V spectrophotometer. Participants will apply one upper and one lower whitening strip once daily for 30 minutes over 14 days.
Follow-up visits will assess compliance, adverse events, oral tissue safety, tooth shade changes, and participant-reported outcomes. Two teeth from the canine-to-canine region (one from each arch) with the highest permissible staining will be evaluated throughout the study. Safety will be monitored in accordance with Good Clinical Practice guidelines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy male or female trial participants aged 18 to 50 years (both inclusive) at the time of screening.
- •Willing and able to provide voluntary written informed consent, including consent for imaging/photographic documentation, prior to study participation.
- •Presence of at least 20 uncrowned permanent natural teeth, excluding third molars.
- •Presence of all maxillary and mandibular anterior teeth suitable for tooth shade assessment.
- •Modified extrinsic tooth stain index (mETSI) score of B to C at baseline.
- •Baseline tooth shade appropriate for whitening evaluation, as determined by investigator assessment using the shade guide.
- •Good general and oral health, as determined by medical history and oral examination.
- •Willingness to refrain from using any non-study teeth whitening or oral cosmetic products during the study period.
- •Willingness to comply with all study procedures, visit schedules, and product usage instructions.
- •Willingness to maintain consistent oral hygiene practices throughout the study and to delay any elective dental treatment (including prophylaxis or cosmetic procedures) during study participation.
- •Willingness to attend all scheduled follow-up visits at the specified times.
- •Agreement not to participate in any other oral or dental clinical study during participation in the current study.
排除标准
- •History of professional teeth whitening or use of over-the-counter whitening or bleaching products within 4 weeks prior to baseline.
- •Participants with tooth shades A1, B1 and C
- •Presence of active oral or dental conditions that may interfere with whitening assessment or product safety, including untreated dental caries, cracked enamel, leaking restorations, pulp pathology, fluorosis, tetracycline stains, abscess, or pulpitis.
- •Presence of crowns, veneers, fixed prostheses, orthodontic appliances, or extensive restorations on anterior teeth that could interfere with tooth shade evaluation.
- •Moderate to severe periodontal disease or other clinically significant oral pathology, as determined by the investigator.
- •Known hypersensitivity or allergy to oral care or personal care products, or to any component of the test product.
- •Ongoing tooth sensitivity or history of severe dentinal hypersensitivity.
- •Use of medications or presence of systemic conditions that, in the investigator’s opinion, may affect oral health, tooth color, or study outcomes (e.g., uncontrolled systemic diseases).
- •Use of medications that may interfere with study outcomes or safety evaluation, including antibiotics, anti-inflammatory drugs, antimicrobial mouth rinses, or psychotropic medications, within a timeframe deemed relevant by the investigator.
- •History of periodontal surgery or invasive dental treatment within 3 weeks prior to baseline.
- •History of radiotherapy to the head and neck region.
- •Pregnant or lactating females, or females planning pregnancy during the study period (self-declared).
- •Current smokers or users of tobacco or smokeless tobacco products that may significantly affect tooth discoloration or oral health.
- •Participation in another clinical study involving an investigational product within 30 days prior to screening.
- •Any condition or circumstance that, in the investigator’s opinion, would compromise the safety of the trial participant or interfere with compliance or study evaluations.
- •Trial participants who are employees of MS Clinical Research or the sponsor.
研究者
Dr Lakshmi Chandrasekran
MS Clinical Research Pvt. Ltd