A Randomized Clinical Trial to Investigate Salivary Flow and pH Following Use of Essential-Oil Containing Mouthwashes
概览
- 阶段
- 4 期
- 干预措施
- Listerine Clinical Solutions Teeth Strength
- 疾病 / 适应症
- Healthy
- 发起方
- Johnson & Johnson Consumer Inc. (J&JCI)
- 入组人数
- 164
- 试验地点
- 1
- 主要终点
- Salivary Flow Rate
- 状态
- 已完成
- 最后更新
- 2年前
概览
简要总结
The purpose of this trial is to evaluate the amount of saliva generated and changes in the oral Potential of Hydrogen (pH) after a single use of essential oil (EO)-containing mouth rinses compared to a negative control. Three EO mouthwash formulations will be investigated in this regard, with the negative control being tap water.
研究者
入排标准
入选标准
- •Able to comprehend and follow the requirements and restrictions of the clinical trial (including willingness to use the assigned study products per instructions, availability on scheduled visit dates and likeliness of completing the clinical trial) based upon research site personnel's assessment
- •Evidence of a personally signed and dated informed consent document indicating the participant (or legally acceptable representative) has been informed of all pertinent aspects of the trial
- •Able to read and understand the local language (participant is capable of reading the documents)
- •Adequate oral hygiene \[that is (i.e.), brush teeth daily and exhibit no signs of oral neglect\]
- •Adults, 18 years of age and older, in good general and oral health without any known allergy to commercial dental products or cosmetics
- •Evidence of being fully vaccinated for COVID-19 (adults 60 years and older)
- •Negative pregnancy urine tests (females of child-bearing potential only)
- •Females of childbearing potential must be using a medically acceptable method of birth control for at least one month prior to Visit 1 and agree to continue using this method during their participation in the clinical trial
- •Resting baseline unstimulated salivary sample must be equal to or greater than 0.3 mL/min to continue in the clinical trial
- •A minimum of 20 natural teeth with scorable facial and lingual surfaces. Teeth that are grossly carious, extensively restored, orthodontically banded, abutments, exhibiting severe generalized cervical and/or enamel abrasion, or third molars will not be included in the tooth count
排除标准
- •History of significant adverse effects, including sensitivities or suspected allergies, following use of oral hygiene products such as toothpastes, mouthwashes and red food dye
- •Dental prophylaxis within four weeks prior to Visit 1
- •History of medical conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures
- •Use of antibiotics, anti-inflammatory or anticoagulant therapy, phenytoin sodium or diphenylhydantoin, cyclosporin A, immunostimulants/ immunomodulators during the clinical trial or within the one month prior to the Baseline exam at Visit
- •Intermittent use of certain antiinflammatory medication (ibuprofen, Aspirin); oral steroids and calcium channel blockers are acceptable at the discretion of the investigator
- •Use of chemotherapeutic anti-plaque/anti-gingivitis products such as triclosan, essential oils, cetylpyridinium chloride (CPC), sodium fluoride with CPC, stannous fluoride, zinc or chlorhexidine digluconate containing mouthwashes and toothpastes within the four weeks prior to Visit 1
- •Known allergy or sensitivity or history of significant adverse effects to any of the investigational product and/or product ingredients (or other ingredients in the products) specifically Cinnamyl Alcohol, Benzyl Alcohol, Citral, Citronellol, Linalool and Limonene
- •Self-reported pregnancy or lactation (this criterion is due to oral tissue changes related to pregnancy and nursing which can affect interpretation of clinical trial results)
- •Self-reported smokeless tobacco user including snuff, chewing tobacco, vaping and e-cigarette usage
- •Males with a pregnant partner or a partner who is currently trying to become pregnant
研究组 & 干预措施
Arm 1: Brush / Listerine Clinical Solutions Teeth Strength
After brushing for 1 timed minute, participants will rinse full strength for 1 minute with Listerine Clinical Solutions Teeth Strength mouthwash.
干预措施: Listerine Clinical Solutions Teeth Strength
Arm 1: Brush / Listerine Clinical Solutions Teeth Strength
After brushing for 1 timed minute, participants will rinse full strength for 1 minute with Listerine Clinical Solutions Teeth Strength mouthwash.
干预措施: Colgate Cavity Protection Toothpaste
Arm 2: Brush / Listerine Total Care Zero
After brushing for 1 timed minute, participants will rinse full strength for 1 minute with Listerine Total Care Zero mouthwash.
干预措施: Listerine Total Care Zero Alcohol Mouthwash
Arm 2: Brush / Listerine Total Care Zero
After brushing for 1 timed minute, participants will rinse full strength for 1 minute with Listerine Total Care Zero mouthwash.
干预措施: Colgate Cavity Protection Toothpaste
Arm 3: Brush / Listerine Cool Mint Zero
After brushing for 1 timed minute, participants will rinse full strength for 30 seconds with Listerine Cool Mint Zero mouthwash.
干预措施: Listerine Cool Mint Zero Alcohol Mouthwash
Arm 3: Brush / Listerine Cool Mint Zero
After brushing for 1 timed minute, participants will rinse full strength for 30 seconds with Listerine Cool Mint Zero mouthwash.
干预措施: Colgate Cavity Protection Toothpaste
Arm 4: Brush / Water (Negative Control)
After brushing for 1 timed minute, participants will rinse with for 1 minute with tap water.
干预措施: Colgate Cavity Protection Toothpaste
结局指标
主要结局
Salivary Flow Rate
时间窗: Taken at Baseline and immediately (0), and at 2.5, 5, 10, 15, and 30 minute timepoints
Saliva samples will be collected by participants at specified timepoints. The final amount of saliva will be weighed and flow rate will be determined.
Saliva Potential of Hydrogen (pH)
时间窗: Taken at Baseline and at 2.5, 5, 10, 15, and 30 minute timepoints
The pH value of saliva will be measured by placing the saliva sample onto the pH sensitive electrode.