Effect of Different Products to Support Plaque Control During Daytime: a Cross-over Single Blinded Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Plaque index
研究概览
简要总结
The goal of this clinical trial is to test if the additional use of different commercially available products for a better breath and plaque reduction, taken during daytime between morning and evening tooth brushing, can reduce the plaque formation of participants during the day.
The tested products were:
- Listerine Total Care mouth rinse without alcohol.
- Oral B Pro-Health Multi-Protection Mouth Rinse refreshing mint without alcohol.
- Colgate total advanced pro-shield mouth rinse without alcohol.
- Listerine Go Tabs.
- Wrigley Extra White Soft Chew Peppermint chewing gum.
The main questions it aims to answer are:
Can the tested product lower the plaque formation? Can the tested product improve the mouth freshness and breath?
Researchers will compare the tested products to not using any product (controls).
Participants need to come for a screening appointment and sign a consent form at first. If they are eligible, they need to come 6 times to the clinic. On each day, they need to come twice (morning appointment at 8 a.m. and evening appointment at 4 p.m.).
In the morning, they will have teeth cleaning and recieve one of the tested products to use on that day only (after tea break and lunch break), or they will recieve no product (control day).
In the evening, participant's teeth will be stained and oral photos will be taken. They will be asked about their perciption of freshness and good breath after using the product.
详细描述
Sample size, study location, and target population:
By using t-test and assuming a pooled standard deviation of 0.35 units, the study required a sample size of 15 participants in total, to achieve a 90% power and 1% level of significance (P<0.05), for detecting a true difference in means between the test and the control group of 0.5 on RMNPI index (Cugini et al 2006). This study is a cross-over study. In other words, participants were their own controls. Therefore, a total number of twenty participants were included in the study (10 males and 10 females).
The staff members of Sydney Dental Hospital were contacted by email to participate in the study. A screening appointment was arranged for interested participants to check for the eligibility criteria.
Study protocol:
One examiner (L.B) examined all participants two or three days a week. One participant was assessed per day. All eligible participants attended the Sydney Dental Hospital for 6 days. On each day, each participant was given a product to use on that day only according to the participant's own randomization list of products. If the day was a control day according to the participant's specific sheet, the participant did not receive anything. Then, the date was documented on each subject's own sheet. A minimum of 3 days wash out period was allowed between experimental days.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
All the assessed parameters were measured by one examiner (L.B) who was blinded. A hospital staff member (dental hygienist, F.Z) was responsible for giving the products to the participants. Each participant was given a unique serial identification number composed of two digits. A unique study ID was used to link participants' name, photos, and product used. The hygienist kept a sheet for each participant. On that sheet the following information was recorded:
- Unique study ID for each participant.
- Participant's first name, surname and date of birth.
- Computer generated randomisation list of control and tested products marked as: product A, product B ... etc.
- The date when each product was disposed to the participant and the type of product.
On each experiment day, a sticker was generated to include the unique ID and the product code that supposed to be received on that day (such as: PPCS 1 Product A, PPCS 2 Product B…etc). It was used to link the oral photos to the unique ID.
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
- •Age is 18 years or more.
- •Generally healthy.
- •All teeth (28 teeth, excluding 3rd molars) should be present.
- •The absence of untreated caries, secondary caries or faulty restorations.
- •No orthodontic appliances (removable or/and fixed).
- •No oral lesions, no active periodontal disease (no active inflammation or bleeding).
- •Not using a mouthwash or any chewing product in the last week before the beginning of the study.
排除标准
- •Pregnancy, lactation.
- •Any chronic disease including diabetes, cardiac disease and diseases of the immune system.
- •Presence of signs and symptoms of an acute infection in the oral cavity.
- •Any prescribed systemic or topical medication.
- •Any known allergies against ingredients of the different tested products.
- •Use of antibiotics in the last 3 months.
- •Use of nonsteroidal anti-inflammatory drugs (NSAID) in the last 3 months.
- •History of alcohol or drug abuse.
研究组 & 干预措施
Listerine Total Care mouth rinse without alcohol
Participants need to use the mouth wash twice a day (after tea break and after lunch break) according to manifacturer instructions: vigorously swish 20mL of rinse in your mouth for 30 seconds and then spit out. Do not swallow. Do not dilute. They were dispensed in their original bottles. Participants were given a marked cup to measure the amount of MW.
干预措施: Listerine Total Care mouth rinse without alcohol (Drug)
Oral B Pro-Health Multi-Protection Mouth Rinse refreshing mint without alcohol (0.07% CPC)
Participants need to use the mouth wash twice a day (after tea break and after lunch break) according to manifacturer instructions: vigorously swish 20mL of rinse in your mouth for 30 seconds and then spit out. Do not swallow. Do not dilute. They were dispensed in their original bottles. Participants were given a marked cup to measure the amount of MW.
干预措施: Oral B Pro-Health Multi-Protection Mouth Rinse refreshing mint without alcohol (0.07% CPC) (Drug)
Colgate total advanced pro-shield mouth rinse without alcohol (0.075% CPC)
Participants need to use the mouth wash twice a day (after tea break and after lunch break) according to manifacturer instructions: vigorously swish 20mL of rinse in your mouth for 30 seconds and then spit out. Do not swallow. Do not dilute. They were dispensed in their original bottles. Participants were given a marked cup to measure the amount of MW.
干预措施: Colgate total advanced pro-shield mouth rinse without alcohol (0.075% CPC) (Drug)
Listerine Go Tabs
Participants need to use the tablet twice a day (after tea break and after lunch break) according to manifacturer instructions: chew for 10 seconds to activate, swish around the teeth for 30 seconds to clean then swallow.
干预措施: Listerine Go Tabs (Drug)
Wrigley Extra White Soft Chew Peppermint chewing gum.
Participants need to use the chewing gum twice a day (after tea break and after lunch break) for 10 minutes duration.
干预措施: Wrigley Extra White Soft Chew Peppermint chewing gum. (Drug)
Control
Participants will not recieve any product to use on the control day
结局指标
主要结局
Plaque index
时间窗: At the end of each test day (6 days)
Plaque accumulation assessed using the Rustogi Modified Navy Plaque Index (RMNPI) on designated tooth surfaces in the sides assigned to interdental brush and water flosser. The tooth was divided into multiple zones as the following : Whole mouth: areas A,B,C,D,E,F,G and H. Marginal (gum line): areas A,B and C. Interproximal: areas D and F 0 score was given the area where there is no plaque. 1 score was given in the area where there is plaque The minimum plaque score per surface (buccal or lingual) is zero, and the maximum plaque score per surface is 8 Intraoral photos using professional camera were taken for all teeth and all surfaces to record the plaque score.
次要结局
- Patient reported outcome using visual analoge scale (VAS)(The VAS was reported by the patients at the end of the assessment day (6 days))
研究者
Lana Bader
Assistant professor
King Abdullah University Hospital