Assessment of the Oral Tissue Tolerance of a Potassium Oxalate Containing Mouthrinse
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Oral Tissue Tolerance
研究概览
简要总结
This study is 8 weeks long. People participating in this study will be asked to brush their teeth two times a day. Some people will get a mouthwash. People with a mouthwash will rinse two times a day after brushing their teeth. The mouth, teeth, tongue and gums will be looked at by a dentist. The dentist will look at the mouth to make sure the mouthwash does not irritate the mouth. The dentist will also look at the color of the teeth and amount of stain on the front teeth.
详细描述
This is an 8-week, randomized, observer-blind, controlled, parallel group clinical study design to assess the oral tissue tolerance of a potassium oxalate containing mouthrinse. Subjects will have their oral soft/hard tissues assessed and will be evaluated for stain levels and tooth color shades at Screening/Baseline (Visit 1), Week 4 (Visit 2), Week 6 (Visit 3) and Week 8 (Visit 4). Subjects will be instructed to brush their teeth two times daily in their usual manner using the provided sodium fluoride toothpaste. Subjects assigned to the mouthrinse group will be instructed to rinse twice daily after brushing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females at least 18 years of age and in good general and oral health.
- •Volunteers must read, sign, and receive a signed copy of the Informed Consent Form after the nature of the study has been fully explained.
- •Willingness to use the assigned products according to instructions, availability for appointments and likelihood of completing the study.
- •Willingness to refrain from using any breath freshener products or unassigned oral care products (i.e., oral care strips, candy-type mints, sprays, chewing gums, throat lozenges, cough drops, mouthwashes or teeth whitening products) throughout the duration of the study.
- •Willingness to refrain from using any whitening products and smokeless tobacco products within one week prior to and for the duration of the study, in order to reduce alternate sources of potential irritation.
- •A minimum of 16 natural teeth, including at least 10 of the 12 anterior teeth (#6-11, #22-27, however, #7-10 must be present), with scorable facial and lingual surfaces. Teeth that are grossly carious, fully crowned or extensively restored on facial and/or lingual surfaces, orthodontically banded, abutments, or third molars will not be included in the tooth count.
- •Classic Vita® Shade minimum value of A2 or darker on at least 2 of the 4 maxillary anterior teeth (#7-10).
- •Absence of abnormal or severely fissured tongue, geographic tongue, tongue piercing or any obvious tongue abnormalities that may interfere with the assessment of oral irritation.
- •Adequate oral hygiene (i.e., brush teeth daily and exhibit no signs of oral neglect).
- •Absence of neglected dental health (i.e. gross calculus deposits or rampant caries based on visual examination), significant oral soft tissue pathology, systemically-related gingival enlargement, tissue damage due to ill-fitting appliances or restoration, or extreme crowding or overlapping of teeth
排除标准
- •Physical limitations or restrictions that might preclude use of normal oral hygiene procedures (i.e., toothbrushing, etc.).
- •History of significant adverse effects following use of oral hygiene products such as toothpastes and mouthrinses.
- •History or current evidence of significant oral soft tissue pathology, excluding gingivitis, based on the dentist's visual examination and at the discretion of the investigator.
- •Prior participation in any oral hygiene or product clinical study within the previous 30 days.
- •Therapy with any medications, currently or within the last 30 days, which might interfere with the outcome of the study by affecting tooth color or stain formation (i.e., certain antimicrobial mouthrinses and antibiotics, such as chlorhexidine).
- •Restorations on 10% or more of the facial surfaces of the maxillary anterior incisor teeth.
- •Dental fluorosis, hypoplasia, restorations, tetracycline stains, or other enamel surface irregularities that may interfere with evaluation of the selected teeth.
- •Visual evidence of Moderate/advanced periodontitis (ADA Type III, IV). Orthodontic bands, appliances, bridges, numerous crowns, removable orthodontic appliances or partial dentures.
- •Self-reported pregnancy or lactation (this criterion is due to oral tissue changes related to pregnancy and nursing which can affect interpretation of study results).
- •Regular use of whitening products within 1 week prior to Screening/Baseline. Other severe, acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial result and, in the judgment of the investigator, would make the subject inappropriate for the entry into this trial.
研究组 & 干预措施
Potassium Oxylate
1.5% potassium oxalate sensitive mouthwash
干预措施: Potassium Oxylate Mouthwash (Device)
Sodium Fluoride
Sodium Fluoride Dentifrice
干预措施: Sodium Fluoride Dentifrice (Drug)
结局指标
主要结局
Oral Tissue Tolerance
时间窗: through 8 weeks
Oral tissue tolerance was assessed by oral tissue adverse events for which the relationship to treatment was considered as possible, probable, or very likely. If the relationship to treatment was missing, the adverse event was categorized as a treatment-related adverse event.
Change in Tooth Color as Represented by ΔE at 8 Weeks Post Baseline From the CIElab Assessment
时间窗: 8 weeks
The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The changes in the individual L\*, a\*, and b\* color parameters were calculated to determine quantitatively the improvements in tooth lightness, redness, and yellowness, respectively. An overall change in tooth color was calculated using the CIE color equation ΔE = \[(ΔL\*)\^2 + (Δa\*)\^2 + (Δb\*)\^2\]\^1/2. The ΔE was calculated per tooth and then averaged over the teeth for a participant.
次要结局
- Change in Tooth Color as Represented by ΔL at 6 Weeks Post Baseline From the CIElab Assessment(6 weeks)
- Change in Tooth Color as Represented by ΔE at 6 Weeks Post Baseline From the CIElab Assessment(6 weeks)
- Change in Tooth Color as Represented by ΔL at 8 Weeks Post Baseline From the CIElab Assessment(8 weeks)
- Change in Tooth Color as Represented by Δb at 4 Weeks Post Baseline From the CIElab Assessment(4 weeks)
- Mean Stain Score Over All Tooth Sites at 6 Weeks(6 weeks)
- Mean Stain Intensity Over All Tooth Sites at 6 Weeks(6 weeks)
- Mean Stain Area Over All Tooth Sites at 4 Weeks(4 weeks)
- Mean Stain Score for Interproximal (Mesial and Distal) Sites at 6 Weeks(6 weeks)
- Mean Stain Score for Gingival Sites at 6 Weeks(6 weeks)
- Change in Tooth Color as Represented by ΔE at 4 Weeks Post Baseline From the CIElab Assessment(4 weeks)
- Change in Tooth Color as Represented by ΔL at 4 Weeks Post Baseline From the CIElab Assessment(4 weeks)
- Change in Tooth Color as Represented by Δb at 6 Weeks Post Baseline From the CIElab Assessment(6 weeks)
- Change in Tooth Color as Represented by Δb at 8 Weeks Post Baseline From the CIElab Assessment(8 weeks)
- Mean Stain Area Over All Tooth Sites at 8 Weeks(8 weeks)
- Mean Stain Score for Interproximal (Mesial and Distal) Sites at 8 Weeks(8 weeks)
- Mean Stain Intensity For Interproximal (Mesial and Distal) Sites at 8 Weeks(8 weeks)
- Mean Stain Area for Interproximal (Mesial and Distal) Sites at 8 Weeks(8 weeks)
- Mean Stain Score Over All Tooth Sites at 4 Weeks(4 weeks)
- Mean Stain Score Over All Tooth Sites at 8 Weeks(8 weeks)
- Mean Stain Intensity Over All Tooth Sites at 4 Weeks(4 weeks)
- Mean Stain Score for Interproximal (Mesial and Distal) Sites at 4 Weeks(4 weeks)
- Mean Stain Area for Gingival Sites at 6 Weeks(6 weeks)
- Mean Stain Intensity Over All Tooth Sites at 8 Weeks(8 weeks)
- Mean Stain Intensity For Interproximal (Mesial and Distal) Sites at 4 Weeks(4 weeks)
- Mean Stain Intensity For Interproximal (Mesial and Distal) Sites at 6 Weeks(6 weeks)
- Mean Stain Area for Interproximal (Mesial and Distal) Sites at 6 Weeks(6 weeks)
- Mean Stain Score for Gingival Sites at 4 Weeks(4 weeks)
- Mean Stain Score for Gingival Sites at 8 Weeks(8 weeks)
- Mean Stain Area Over All Tooth Sites at 6 Weeks(6 weeks)
- Mean Stain Area for Interproximal (Mesial and Distal) Sites at 4 Weeks(4 weeks)
- Mean Stain Intensity for Body Sites at 4 Weeks(4 weeks)
- Mean Stain Intensity for Body Sites at 6 Weeks(6 weeks)
- Mean Stain Intensity for Facial Sites at 6 Weeks(6 weeks)
- Mean Stain Intensity for Gingival Sites at 4 Weeks(4 weeks)
- Mean Stain Intensity for Gingival Sites at 8 Weeks(8 weeks)
- Mean Stain Area for Gingival Sites at 4 Weeks(4 weeks)
- Mean Stain Area for Gingival Sites at 8 Weeks(8 weeks)
- Mean Stain Intensity for Body Sites at 8 Weeks(8 weeks)
- Mean Stain Area for Body Sites at 8 Weeks(8 weeks)
- Mean Stain Intensity for Gingival Sites at 6 Weeks(6 weeks)
- Mean Stain Score for Body Sites at 4 Weeks(4 weeks)
- Mean Stain Score for Lingual Sites at 4 Weeks(4 weeks)
- Mean Stain Area for Lingual Sites at 8 Weeks(8 weeks)
- Mean Stain Score for Body Sites at 6 Weeks(6 weeks)
- Mean Stain Area for Body Sites at 4 Weeks(4 weeks)
- Mean Stain Area for Facial Sites at 4 Weeks(4 weeks)
- Mean Stain Area for Facial Sites at 8 Weeks(8 weeks)
- Mean Stain Score for Lingual Sites at 6 Weeks(6 weeks)
- Mean Stain Score for Body Sites at 8 Weeks(8 weeks)
- Mean Stain Area for Body Sites at 6 Weeks(6 weeks)
- Mean Stain Score for Facial Sites at 4 Weeks(4 weeks)
- Mean Stain Area for Facial Sites at 6 Weeks(6 weeks)
- Mean Stain Score for Facial Sites at 6 Weeks(6 weeks)
- Mean Stain Score for Facial Sites at 8 Weeks(8 weeks)
- Mean Stain Intensity for Facial Sites at 4 Weeks(4 weeks)
- Mean Stain Intensity for Facial Sites at 8 Weeks(8 weeks)
- Mean Stain Score for Lingual Sites at 8 Weeks(8 weeks)
- Mean Stain Intensity for Lingual Sites at 4 Weeks(4 weeks)
- Mean Stain Intensity for Lingual Sites at 6 Weeks(6 weeks)
- Mean Stain Intensity for Lingual Sites at 8 Weeks(8 weeks)
- Mean Stain Area for Lingual Sites at 4 Weeks(4 weeks)
- Mean Stain Area for Lingual Sites at 6 Weeks(6 weeks)