Clinical Research Study to Evaluate the Antibacterial Effect 12 Hours After 4-week Use of a Toothpaste Containing Amine Base, Sodium Fluoride and Zinc Lactate
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 130
- 主要终点
- Change of oral bacteria load
研究概览
简要总结
The aim of this study is to evaluate the antibacterial effect 12 hours after 4-week use of a toothpaste containing amine base, zinc lactate, and fluoride. For this, healthy people will be invited to use two different toothpaste: control - containing only fluoride; test - containing fluoride plus a combination with zinc. The primary outcome is the efficacy of the test toothpaste in the oral bacterial load reduction in samples of saliva and oral mucosa (obtained through scraping); the second outcome is effect of the test toothpaste in the expression of mucin in the oral mucosa.
详细描述
Study Design This is a phase III, randomized, single center, parallel-group, double-blind clinical study to evaluate the antibacterial effect of a toothpaste containing an amine, zinc lactate, and fluoride base.
Primary Objective The objective of this study is to evaluate the antibacterial effect 12 hours after using a toothpaste containing amine, zinc lactate and fluoride for 4 weeks.
Secondary Objectives The secondary objective will be to evaluate the impact of a toothpaste containing amine, zinc lactate and fluoride in the quantification of mucin on the surface of the oral mucosa.
Study Intervention Design: Parallel Product Assignment: Randomization Number of individuals: 130 Individuals by age group: 18 to 70 Number of test groups: 2 Treatment regimen: Brushing of the entire mouth with test toothpaste Blind Mode: Double-blind Number of exposures (uses): Twice a day, unattended Study duration: 6 weeks Washout period: Yes Duration of each exposure: 2 minutes of brushing
Study Groups:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Randomization lists will be kept confidential by the Investigator, inside a locked cabinet. As patients are included by the Examiner at the first visit (T0), the Investigator will make the allocation. The Examiner and other team members, including the Laboratory Technician, will not know the group to which the patient belongs.
Toothpastes will be covered with white paper to disguise the identity of the product.
Participants will also not know which group they belong to and which investigational product they are using. To this end, the products will be distributed in a separate area of the exam room by the Assistant, without the other participants being present.
The samples will also be labeled with the information of the participant's first and last name initials, the randomization code and the sample collection data (type, intraoral location and collection date). The Laboratory Technician will not know which group the sample belongs to.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female subjects, ages 18-70, inclusive;
- •Subjects are available during study duration;
- •Subject is in good general health;
- •A minimum of 15 natural teeth with facial and lingual scorable surfaces, excluding third molars.
- •A willingness to read, understand, and sign the Informed Consent Form after the nature of the study has been fully explained to them.
- •Subjects with baseline whole mouth scores of dental plaque of 1.5 or more and gingivitis index of 1.0 or more.
排除标准
- •Participation in any other clinical study or test panel including clinical studies with oral hygiene formulations within the one month prior to entry into the study.
- •History of dental prophylaxis or treatments in the past month or during study duration.
- •History of medical treatments (e.g: antibiotic, anti-inflammatory, anticoagulant, etc.) during the month preceding study enrollment.
- •Subjects scheduled for any medical procedure during the course of the study.
- •Difficulty complying with study procedures and examinations such as excessive gagging during oral assessment etc.
- •History of significant adverse effects following use of oral hygiene products such as toothpastes and mouthrinses. Allergies to personal care/consumer products or their ingredients.
- •History of diabetes, hepatic, renal disease, inflammatory conditions or transmittable diseases, e.g. heart disease or AIDS.
- •History of rheumatic fever or medical conditions that require prophylactic antibiotics coverage prior to dental procedures.
- •Presence of oral lesions.
- •History of active or severe periodontal disease (PD > 4) and loose teeth.
- •Gross dental caries, severe generalized cervical abrasion and/or enamel abrasion, large fractured or temporary restorations (based on visual examinations).
- •Fixed or removable orthodontic appliances or removable partial dentures.
- •Current smokers and subjects with a history of alcohol or drug abuse.
- •Use of phenolic flavored products, such as mint flavored candies and chewing gum, during the study period.
- •Unable to refrain from oral hygiene for twelve (12) hours prior to scheduled visits.
- •Positive Coronavirus Disease 2019 test 48 hours prior to the screening visit.
研究组 & 干预措施
Fluoride toothpaste
Participants will brush their teeth with a commercially available Fluoride toothpaste (1450 ppm F) and a commercially available adult soft bristle toothbrush
干预措施: Fluoride Toothpaste (Combination Product)
Zinc toothpaste
Participants will brush their teeth with a toothpaste containing amine base, zinc lactate and fluoride (1400 ppm F) and a commercially available adult soft bristle toothbrush
干预措施: Zinc toothpaste (Combination Product)
结局指标
主要结局
Change of oral bacteria load
时间窗: Baseline (previously of the interventions) and after 4 weeks of the interventions
analysis of oral bacterial load (log10 colony-forming unit/mL) in saliva and oral mucosa biofilm samples, performed by microbial culture
次要结局
- Change of mucin expression in oral mucosa samples(Baseline (previously of the interventions) and after 1, 2, 3 and 4 weeks of the interventions)