Efficacy of a Commercial Dentifrice Containing 10% High Cleaning Silica Base, 0.5% Sodium Phytate and 0.5% Sodium Pyrophosphate on Tooth Whitening: A 8-week Clinical Study in Adults in China
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Lobene Stain Index of Stain Extent Scores 8 Weeks After Dentifrice Use
研究概览
简要总结
The objective of the present study was to compare the effects of a commercially available dentifrice containing 10% high cleaning silica base, 0.5% sodium phytate and 0.5% sodium pyrophosphate versus a negative control dentifrice on removal of extrinsic stains.
详细描述
There is great concern on the tooth esthetics and color among people, especially young adults. Great efforts have been made in order to improve patients' smile. Epidemiological studies have reported that dissatisfaction with tooth color ranged from 19.6% to 65.9%, depending on different population. An oral health related quality of life questionnaire for use among young adults reported that tooth color was the most important concern. This dissatisfaction with tooth color has been shown to be associated with increased desire for treatments that improve dental aesthetics including tooth whitening dentifrices. Tooth whitening products generally help to improve the overall whiteness of teeth, by removing and controlling the formation of extrinsic stains. In recent years the interest on the treatment of tooth stain with various tooth whitening agents, among which dentifrice containing high cleaning silica is widely used.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged between 18-70 years old
- •Good general health
- •Could attend the clinical examinations during the 8 week study period
- •Possessing >20 natural permanent teeth that were uncrowned or heavily filled with restorative materials, excluding third molars
- •Having a whole-mouth mean tooth stain score of more than 1.5 according to the Lobene index.
排除标准
- •Severe oral diseases, chronic disease or allergic to the trial products
- •Advanced periodontal diseases
- •Females who are pregnant or lactating
- •Taking part in other clinical trials
- •Taking part in orthodontic treatment or wearing removable denture
- •Fluorosis or tetracycline teeth
- •Receiving prophylaxis during the previous 3 months or tooth whitening treatment during the past 6 months.
研究组 & 干预措施
Toothpaste containing effective ingredients
Use the toothpaste containing 10% high cleaning silica base,0.5% sodium phytate and 0.5% sodium pyrophosphate to brush teeth twice daily for 8 weeks
干预措施: Toothpaste containing 10% high cleaning silica base, 0.5% sodium phytate and 0.5% sodium pyrophosphate (Drug)
Negative control toothpaste
Use the negative control dentifrice to brush teeth twice daily for 8 weeks
干预措施: Control toothpaste (Drug)
结局指标
主要结局
Lobene Stain Index of Stain Extent Scores 8 Weeks After Dentifrice Use
时间窗: 8 weeks after dentifrice use
Tooth stain of the anterior teeth were measured using the Lobene Stain Index. The index measures the area and intensity of extrinsic tooth stain on the facial and lingual surfaces of the lower anterior teeth and facial surfaces of the upper anterior teeth. The tooth surfaces were divided into two parts: body and gingival. For each part, the stain intensity was assessed using 0-3 scale. 0= No stain; 1=Light stain(yellow to light brown or gray); 2=Moderate stain(medium brown); 3=Heavy stain(dark brown to black).
Lobene Stain Index of Stain Extent Scores 4 Weeks After Dentifrice Use
时间窗: 4 weeks after dentifrice use
Tooth stain of the anterior teeth were measured using the Lobene Stain Index. The index measures the area and intensity of extrinsic tooth stain on the facial and lingual surfaces of the lower anterior teeth and facial surfaces of the upper anterior teeth. The tooth surfaces were divided into two parts: body and gingival. For each part, the stain intensity was assessed using 0-3 scale. 0= No stain; 1=Light stain(yellow to light brown or gray); 2=Moderate stain(medium brown); 3=Heavy stain(dark brown to black).
Lobene Stain Index of Stain Composite Scores 8 Weeks After Dentifrice Use
时间窗: 8 weeks after dentifrice use
Tooth stain of the anterior teeth were measured using the Lobene Stain Index. The tooth surfaces were divided into two parts: body and gingival. For each part, the stain area was assessed using 0-3 scale and the stain intensity was assessed using 0-3 scale. Lobene Stain Index: Composite for each part is the product of the stain area and intensity scores. The minimum score for Lobene Stain Index: Composite is 0 when both the stain area and intensity scores are 0. The maximum score for Lobene Stain Index: Composite is 9 when both the stain area and intensity scores are 3.
Lobene Stain Index of Stain Area Scores 4 Weeks After Dentifrice Use
时间窗: 4 weeks after dentifrice use
Tooth stain of the anterior teeth were measured using the Lobene Stain Index. The index measures the area and intensity of extrinsic tooth stain on the facial and lingual surfaces of the lower anterior teeth and facial surfaces of the upper anterior teeth. The tooth surfaces were divided into two parts: body and gingival. For each part, the stain area was assessed using 0-3 scale. 0= No stain detected; 1= stain covering up to 1/3 of the region; 2= Stain covering \>1/3 to 2/3 of the region; 3=Stain covering \>2/3 of the region.
Lobene Stain Index of Stain Composite Scores 4 Weeks After Dentifrice Use
时间窗: 4 weeks after dentifrice use
Tooth stain of the anterior teeth were measured using the Lobene Stain Index. The tooth surfaces were divided into two parts: body and gingival. For each part, the stain area was assessed using 0-3 scale and the stain intensity was assessed using 0-3 scale. Lobene Stain Index: Composite for each part is the product of the stain area and intensity scores. The minimum score for Lobene Stain Index: Composite is 0 when both the stain area and intensity scores are 0. The maximum score for Lobene Stain Index: Composite is 9 when both the stain area and intensity scores are 3.
Lobene Stain Index of Stain Area Scores 8 Weeks After Dentifrice Use
时间窗: 8 weeks after dentifrice use
Tooth stain of the anterior teeth were measured using the Lobene Stain Index. The index measures the area and intensity of extrinsic tooth stain on the facial and lingual surfaces of the lower anterior teeth and facial surfaces of the upper anterior teeth. The tooth surfaces were divided into two parts: body and gingival. For each part, the stain area was assessed using 0-3 scale. 0= No stain detected; 1= stain covering up to 1/3 of the region; 2= Stain covering \>1/3 to 2/3 of the region; 3=Stain covering \>2/3 of the region.
次要结局
未报告次要终点
研究者
Liu Hongchun
Principal Investigator
Hospital of Stomatology, Sun Yat-Sen University