Clinical, Instrumental, and Subjective Evaluation of the Anti-Halitosis Efficacy, Effects on Oral Comfort, and Sensory Acceptability of a 50+ Toothpaste Compared With a Standard Toothpaste in Orally Healthy Adults: A Randomized, Controlled, Double-Blind, Crossover Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change From Baseline in Oral Volatile Sulfur Compound Concentration After 14 Days
研究概览
简要总结
The goal of this clinical trial is to compare a toothpaste designed for adults aged 50 years and older with a standard toothpaste in orally healthy adults. The main question is whether the 50+ toothpaste reduces bad breath more than the standard toothpaste after 14 days of twice-daily use. The study will also assess tongue coating, dry mouth symptoms, saliva production, oral comfort, oral health-related quality of life, taste, acceptability, and unwanted effects.
About 30 adults aged 18 to 65 years will take part. Each participant will use both toothpastes for 14 days each, in a randomly assigned order, with a 14-day break between the two treatment periods. Neither the participants nor the examiner performing the assessments will know which toothpaste is being used during each period.
At the study visits, bad breath will be measured using a device that detects volatile sulfur compounds in the mouth. Participants will also undergo an examination of the tongue, provide saliva samples, and complete questionnaires. Before each assessment visit, participants will be asked not to perform oral hygiene for 24 hours and to avoid food, drinks other than water, smoking, chewing gum, and oral care products for 3 to 4 hours.
详细描述
This study will evaluate whether a toothpaste formulated for adults aged 50 years and older provides greater control of oral malodor and improved oral comfort compared with a standard commercially available fluoride toothpaste. Oral malodor will be assessed under standardized conditions using a reversible physiological model based on the temporary suspension of oral hygiene. No chemical substance will be used to induce malodor.
The study will use a randomized crossover design. Each participant will receive both study products in a randomly assigned sequence. Each treatment period will last 14 days and will be separated by a 14-day washout period, during which participants will return to their usual oral hygiene routine while avoiding products specifically intended for halitosis or dry mouth. Participants will brush twice daily for 2 minutes using only the assigned toothpaste. Tongue brushing and the use of mouthwashes or other products that could affect oral malodor or dry mouth will not be permitted during the treatment periods.
The test and control toothpastes will be supplied in neutral, indistinguishable packaging. Participants and the examiner responsible for the clinical and instrumental assessments will remain unaware of product identity. The treatment codes will be disclosed only after the study database has been finalized, unless disclosure is required for participant safety.
Assessments will be performed at baseline and after 7 and 14 days of each treatment period. Before each assessment, participants will suspend oral hygiene for 24 hours and follow standardized restrictions concerning food, beverages, smoking, chewing gum, and oral care products. This approach is intended to reduce measurement variability and allow each participant to serve as their own control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The statistician will remain masked to treatment identity and will analyze the products using coded labels. Both toothpastes will be provided in neutral, indistinguishable packaging. The randomization list and the link between product codes and treatment identity will be held by designated personnel who are not involved in outcome assessment or statistical analysis. Treatment codes will be disclosed only after database lock, unless unmasking is required for participant safety.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 65 years.
- •Male or female.
- •Orally healthy according to clinical examination, with no active oral condition that could interfere with study outcomes.
- •At least 20 natural teeth.
- •No active periodontitis.
- •No clinically relevant untreated cavitated caries.
- •No acute oral mucosal disease.
- •Any existing systemic condition must be stable, controlled, and considered unlikely to interfere with the study outcomes.
- •Willingness to use only the oral care products provided during each treatment period.
- •Willingness to refrain from oral hygiene procedures for 24 hours before each assessment visit.
- •Willingness to refrain from food, beverages other than water, smoking, chewing gum, candies, oral sprays, mouthwashes, and oral hygiene procedures for 3 to 4 hours before each assessment.
- •Ability to understand the study objectives and procedures.
- •Provision of written informed consent.
排除标准
- •Active oral or dental disease that could interfere with the study outcomes. Active periodontitis.
- •Periodontal probing depths greater than 3 mm at multiple sites, according to clinical judgment.
- •Clinically relevant generalized gingival bleeding.
- •Clinically relevant untreated cavitated caries.
- •Oral candidiasis.
- •Oral ulceration, stomatitis, symptomatic oral mucosal lesions, or acute oral infection.
- •Clinical signs of severe xerostomia or pathological hyposalivation.
- •Fewer than 20 natural teeth.
- •Acute systemic disease or uncontrolled chronic systemic disease. Uncontrolled diabetes mellitus.
- •Active autoimmune or systemic inflammatory disease.
- •Gastrointestinal, respiratory, otorhinolaryngological, or metabolic conditions associated with clinically significant extraoral halitosis.
- •Use of systemic antibiotics within 4 weeks before enrollment.
- •Habitual use of antiseptic mouthwashes, anti-halitosis products, or dry-mouth products within 2 weeks before enrollment.
- •Use of medications with a strong xerostomic effect that, in the investigator's judgment, could interfere with study outcomes.
- •Smoking more than 10 cigarettes per day.
- •Inability to refrain from smoking for 3 to 4 hours before assessment visits.
- •Pregnancy or breastfeeding.
- •Known or suspected allergy to any component of the study products.
- •Professional dental cleaning or invasive dental procedures within 2 weeks before enrollment.
- •Inability or unwillingness to comply with the study procedures.
- •Participation in another clinical study within 4 weeks before enrollment.
研究组 & 干预措施
50+ Toothpaste Followed by Standard Toothpaste
Participants will use the 50+ toothpaste twice daily for 14 days, followed by a 14-day washout period. They will then use the standard toothpaste twice daily for 14 days. Each brushing session will last 2 minutes.
干预措施: 50+ Toothpaste (Other)
50+ Toothpaste Followed by Standard Toothpaste
Participants will use the 50+ toothpaste twice daily for 14 days, followed by a 14-day washout period. They will then use the standard toothpaste twice daily for 14 days. Each brushing session will last 2 minutes.
干预措施: Standard Fluoride Toothpaste (Other)
Standard Toothpaste Followed by 50+ Toothpaste
Participants will use the standard toothpaste twice daily for 14 days, followed by a 14-day washout period. They will then use the 50+ toothpaste twice daily for 14 days. Each brushing session will last 2 minutes.
干预措施: 50+ Toothpaste (Other)
Standard Toothpaste Followed by 50+ Toothpaste
Participants will use the standard toothpaste twice daily for 14 days, followed by a 14-day washout period. They will then use the 50+ toothpaste twice daily for 14 days. Each brushing session will last 2 minutes.
干预措施: Standard Fluoride Toothpaste (Other)
结局指标
主要结局
Change From Baseline in Oral Volatile Sulfur Compound Concentration After 14 Days
时间窗: Baseline (T0), after 7 days of treatment (T1), and after 14 days of treatment (T2) in each treatment period
Oral volatile sulfur compound concentration will be measured using a Halimeter Plus and expressed in parts per billion (ppb). At each assessment, three valid consecutive measurements will be obtained, and their mean will be used for analysis. For each treatment period, change from baseline will be calculated as the value after 14 days minus the baseline value. Lower values and greater reductions indicate improvement in oral malodor. The primary comparison will assess the within-participant difference in change between the 50+ toothpaste and the standard fluoride toothpaste.
次要结局
- Percentage Change From Baseline in Oral Volatile Sulfur Compound Concentration(Baseline (T0), after 7 days of treatment (T1), and after 14 days of treatment (T2) in each treatment period)
- Change From Baseline in Tongue Coating Severity Score(Baseline (T0), after 7 days of treatment (T1), and after 14 days of treatment (T2) in each treatment period)
- Change From Baseline in Participant-Reported Oral Malodor(Baseline (T0), after 7 days of treatment (T1), and after 14 days of treatment (T2) in each treatment period)
- Change From Baseline in Summated Xerostomia Inventory Score(Baseline (T0), after 7 days of treatment (T1), and after 14 days of treatment (T2) in each treatment period)
- Change From Baseline in Participant-Reported Oral Dryness(Baseline (T0), after 7 days of treatment (T1), and after 14 days of treatment (T2) in each treatment period)
- Change From Baseline in Participant-Reported Oral Comfort(Baseline (T0), after 7 days of treatment (T1), and after 14 days of treatment (T2) in each treatment period)
- Change From Baseline in Oral Health Impact Profile-14 Total Score(Baseline (T0) and after 14 days of treatment (T2) in each treatment period)
- Change From Baseline in Unstimulated Salivary Flow Rate(Baseline (T0), after 7 days of treatment (T1), and after 14 days of treatment (T2) in each treatment period)
- Change From Baseline in Stimulated Salivary Flow Rate(Baseline (T0), after 7 days of treatment (T1), and after 14 days of treatment (T2) in each treatment period)
- Overall Taste Pleasantness Score(After 14 days of treatment (T2) in each treatment period)
- Perceived Freshness Score(After 14 days of treatment (T2) in each treatment period)
- Perceived Taste Persistence Score(After 14 days of treatment (T2) in each treatment period)
- Unpleasant Aftertaste Score(After 14 days of treatment (T2) in each treatment period)
- Willingness to Continue Using the Toothpaste(After 14 days of treatment (T2) in each treatment period)
- Participant-Reported Product Attribute Ratings(After 14 days of treatment (T2) in each treatment period)
- Incidence of Treatment-Emergent Adverse Events(From the first product administration at T0 through the final assessment at T2 of the second treatment period, approximately 6 weeks)
研究者
Andrea Scribante
Associate Professor, Principal Investigator
University of Pavia