An 8-Week Clinical Study to Evaluate the Efficacy of Two Oral Hygiene Regimens in the Reduction of Dentin Hypersensitivity After Non-surgical Periodontal Treatment: Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Dentin hypersensitivity reduction
研究概览
简要总结
This study aim is to determine the efficacy of two Oral Hygiene Regimens in the reduction of dentin hypersensitivity on subjects undergoing non-surgical periodontal treatment, over a period of 8 weeks.
详细描述
This study aim was to determine the efficacy of two Oral Hygiene Regimens in the reduction of dentin hypersensitivity on subjects undergoing non-surgical periodontal treatment, over a period of 8 weeks. The study was conducted in Piracicaba Dental School, Piracicaba, São Paulo, Brazil, using a double-blind/two treatment design. Sixty subjects (30 per group) that meet the inclusion and exclusion criteria were assigned to the groups: Test group (Non-surgical periodontal treatment + In-office application of Colgate Sensitive Pro-Relief - CSPR + tooth brushing with at home CSPR toothpaste) and Control group (Non-surgical periodontal treatment + In-office application of a fluoride-free prophy paste + tooth brushing with a Colgate Cavity Protection Toothpaste). Air blast sensitivity assessments were used to compare the efficacy of the two approaches using both the Schiff scale. The sensitivity parameters were measured at baseline, 1, 4 and 8 weeks.
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, Investigator)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females, between 30-75 years of age;
- •Availability for the duration of the study;
- •Individuals diagnosed with moderate chronic periodontal disease (4-5 mm loss of clinical attachment, according to AAP), and indication for non-surgical periodontal therapy;
- •Diagnosis, by air blast, of at least two (2) hypersensitive teeth with a score of 2 or 3 on the Schiff Cold Air Sensitivity Scale;
- •Subjects in good general health and no allergies to products that are being tested.
排除标准
- •Oral pathology, chronic disease, or a history of allergy to testing products;
- •Qualifying sensitive teeth with extensive/defective restorations, pulpitis, caries, cracked enamel, or these teeth used as abutments for removable partial dentures;
- •Subject using anticonvulsants, antihistamines, antidepressants, sedatives, tranquilizers, anti-inflammatory medication or daily analgesics within one month prior to the start of the study or scheduled to start such intake during the course of the study;
- •Subject regularly using desensitizing toothpaste;
- •Current smokers;
- •Subject pregnant or breast feeding;
- •Allergies to oral care products, personal care consumer products, or their ingredients.
研究组 & 干预措施
CSPR + NS treatment
In-office and at home Colgate sensitive pro-relief - CSPR
Intervention: Non-surgical periodontal treatment (full-mouth debridement, scaling and root planing with ultrasonic/hand instruments) associated with In-office application of Colgate Sensitive Pro-Relief (CSPR) + tooth brushing with at home CSPR toothpaste during 8 weeks.
干预措施: In-office and at home Colgate sensitive pro-relief - CSPR (Drug)
CSPR + NS treatment
In-office and at home Colgate sensitive pro-relief - CSPR
Intervention: Non-surgical periodontal treatment (full-mouth debridement, scaling and root planing with ultrasonic/hand instruments) associated with In-office application of Colgate Sensitive Pro-Relief (CSPR) + tooth brushing with at home CSPR toothpaste during 8 weeks.
干预措施: Non-surgical periodontal treatment (Procedure)
Villevie® + NS treatment
In-office Villevie® prophy paste + Colgate Toothpaste
Treatment: In-office application of a Villevie® (fluoride-free) prophy paste + tooth brushing with a Colgate Cavity Protection Toothpaste during 8 weeks, after non-surgical periodontal treatment. (Full-mouth debridment/ Scaling and root planing with ultrasonic/hand instruments)
干预措施: In-office Villevie® prophy paste + Colgate Toothpaste (Drug)
Villevie® + NS treatment
In-office Villevie® prophy paste + Colgate Toothpaste
Treatment: In-office application of a Villevie® (fluoride-free) prophy paste + tooth brushing with a Colgate Cavity Protection Toothpaste during 8 weeks, after non-surgical periodontal treatment. (Full-mouth debridment/ Scaling and root planing with ultrasonic/hand instruments)
干预措施: Non-surgical periodontal treatment (Procedure)
结局指标
主要结局
Dentin hypersensitivity reduction
时间窗: Baseline, 8 weeks
Air blast sensitivity assessments using Schiff scale at baseline and up to 8 weeks after non-surgical periodontal treatment.
次要结局
- Probing depth reduction(Baseline, 8 weeks)
研究者
Enilson Antonio Sallum
Professor, department of Periodontics, Piracicaba Dental School, State University of Campinas (UNICAMP), Piracicaba, São Paulo, Brazil
University of Campinas, Brazil