EFFECTIVENESS OF A HOMECARE DESENSITIZER FOR PATIENTS WITH DENTIN HYPERSENSITIVITY
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- dentine hypersensitivity with visual analog scale (VAS) following tactile, thermal and osmotic stimulus
研究概览
简要总结
Aim: To evaluate the effectiveness of a desensitizing gel for topical and home use in the treatment of dentin hypersensitivity (DH) through a randomized clinical trial, double-blind, with three parallel treatment. Methods: 126 subjects were divided into three groups: placebo gel (PG), test gel (TG) (5% sodium fluoride, potassium oxalate 5%, strontium chloride 10%) and sodium fluoride gel (2% FG ). The measurement of DH was performed by a single examiner blinded by the visual analog scale (VAS) after tactile, thermal and osmotic stimuli in the Baseline, 7, 15 and 30 days.
详细描述
STUDY POPULATION
The sample was recruited in clinics of the School of Dentistry at the Franciscan University Center and the specialization course in Periodontics at the University of Inga - . St. Mary (UNINGÁ). After the selection of patients, issues related to medical and dental history were collected through a semi-structured questionnaire. Subsequently, in teeth included in the study, conducted the assessment of gingival recession and the width and depth (in the case of the presence of non-carious cervical lesions) in millimeters with a millimeter probe type Willians (Neumar®, São Paulo , SP , Brazil) to estimate the area of wear in mm3. Still, the recession of each subject was classified according to its probable etiology and associated with periodontal disease (recession on the buccal surface and proximal surfaces on the teeth with DH in a subject with attachment loss ≥ 3 mm and probing depth ≥ 3mm affecting interproximal sites of two non-adjacent or more teeth). The others were considered associated with brushing trauma.
SAMPLE SIZE
The calculation of sample size was based on a clinically significant difference between two groups in the reduction of DH after stimulation with compressed air (mean difference of 20 mm and a standard deviation of 30mm on a visual analog scale). Considering a significance level of 5%, power 80% of the study and design in parallel, were estimated at least 36 patients for each group. Considering a dropout rate of 15% of the study, the size was increased to 42 eligible individuals per group.
RANDOMIZATION
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
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible individuals who had been considered with a tooth with gingival recession and DH caused by at least one of the stimuli, heat (air), tactile (probe) and/or osmotic (water). If the subject submit more than one tooth with DH, the most sensitive element to the air test was chosen as the unit of analysis. Molars were excluded from analysis.
排除标准
- •Ineligible individuals were characterized by exhibiting one of the following conditions:
- •Had undergone periodontal surgery in the last three months;
- •Chronic use of anti-inflammatory and analgesic,
- •Receiving specific treatment for DH,
- •Presented hypersensitivity to any of the compounds used in the study;
- •Pregnant or lactating;
- •Systemic conditions that could cause or predispose the development of DH (oesophageal reflux);
- •subjects whose diet submit excess acidic substances;
- •Persons whose tooth with DH present carie cavities, fractures, pulp necrosis or some pulp symptoms diagnosed through pulp sensitivity tests to cold;
- •Present congenital defects in enamel or dentin;
- •Present extensive restoration carried out in the last three months
- •Present dental crowns and abutment of fixed or removable prosthesis.
- •Exclusion criteria after the start of the study:
- •Patients who did not returned calls for the achievement of sensitivity tests in the stipulated period;
- •Individuals that did not use adequadely the product;
- •Subjects that desist from participating in the search, for any reason.
- •Participants who presented worsening of DH;
- •Subjects that presented some kind of reaction was observed, irritation or allergy to any of the products.
研究组 & 干预措施
placebo
Individuals that were randomized for treatment " A " . The product tested were always delivered in a transparent plastic syringe with 10 mls marking identified by the letters " A " . The syringes were given to individuals in an opaque plastic envelope sealed and delivered along with a reminder of the correct way to use the products. Guidance for the use of substances was to make application with a new toothbrush, 1 time a day (at night, before bed, after brushing the teeth) with the product received, for 1 minute and the amount of 0.25 g (0.5 ml) of the product as the demarcation the syringe. It was recommended that after using the products, they were expelled without rinsing the oral cavity with water (Placebo gel).
干预措施: placebo gel (Drug)
Experimental gel
Individuals that were randomized for treatment " B " - The product was delivered in a transparent plastic syringe with 10 mls identified by the letter " B ". The syringes were given to individuals in an opaque plastic envelope sealed and with a reminder of the correct way to use the products. Guidance for the use of substances was to make application with a new toothbrush, 1 time a day (at night, before bed, after brushing the teeth) with the product received, for 1 minute and the amount of 0.25 g (0.5 ml) of the product as the demarcation the syringe. It was recommended that after using the products, they were expelled without rinsing the oral cavity with water (5% sodium fluoride, potassium oxalate 5%, strontium chloride 10% ) .
干预措施: 5% sodium fluoride, potassium oxalate 5%, strontium chloride 10% (Drug)
Positive control
Individuals that were randomized for treatment " C " . The product tested were always delivered in a transparent plastic syringe with 10 mls marking identified by the letters " C " . The syringes were given to individuals in an opaque plastic envelope sealed and delivered along with a reminder of the correct way to use the products. Guidance for the use of substances was to make application with a new toothbrush, 1 time a day (at night, before bed, after brushing the teeth) with the product received, for 1 minute and the amount of 0.25 g (0.5 ml) of the product as the demarcation the syringe. It was recommended that after using the products, they were expelled without rinsing the oral cavity with water (Fluoride neutral NaF gel 2 %).
干预措施: Fluoride neutral NaF gel 2 % (Drug)
结局指标
主要结局
dentine hypersensitivity with visual analog scale (VAS) following tactile, thermal and osmotic stimulus
时间窗: Change from Baseline in VAS Scale at 30 days.
The DH was measured on 30 days after products use. It was evaluated on the buccal surface of the tooth selected using a visual analog scale (VAS) immediately after application of the air jet, created with the triple syringe, at a distance of 10 mm from the tooth for 10 seconds, in the region of exposure root. The touch test was performed on the exposed root surface by applying a light force with blunt probe perpendicular to the long axis of the tooth for 10 seconds. Finally, we applied the test with water jet, using the perpendicular triple syringe and spaced 10 mm of the tooth to be tested. DH evaluations were performed with an interval of 1 minute to minimize interactions between examinations. All reviews of DH were conducted by a single trained examiner (M.M.).
次要结局
- Bad taste(Change from Baseline in possible adverse reactions at 30 days.)
- Allergy(Change from Baseline in possible adverse reactions at 30 days.)
- Irritation(Change from Baseline in possible adverse reactions at 30 days.)
研究者
Fabricio Batistin Zanatta
Orientador principal
Universidade Federal de Santa Maria