The Effect of Toothpastes Based on Alkaline Thermal Water With and Without Fluorinated Derivative on Gingivitis, Dentin Hypersensitivity, and Oral Hygiene: a Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Evaluation of DH according to Shiff sensitivity score
研究概览
简要总结
The aim of the study is to compare the effect of toothpastes containing thermal water of Castera-Verduzan with 1450 ppm fluoride and without fluorinated derivatives on oral hygiene, gingivitis, and dentin hypersensitivity in young adults.
详细描述
This will be a double-blind, randomized, two-arm parallel-group study of the effect of toothpastes containing thermal water of Castera-Verduzan with 1450 ppm fluoride and without fluorinated derivatives. The groups will include adults with gingivitis and dentinal hypersensitivity (DH) diagnosed clinically. To assess the effect of the toothpastes, the following parameters will be used: gingival health (modified gingival index, MGI; gingival bleeding index, BI), dentin sensitivity (Shiff's index, VAS), oral hygiene level (Navi-Rustogi index), and salivary pH.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The allocation concealment will be performed using sealed containers numbered by a "third party" (person who will not participate in the study). The toothpastes in white bottles without any titles will be placed in the containers. Each patient will receive a sealed container with a toothpaste on enrolment. Neither patients nor researchers will be aware of the type of the toothpaste used.
入排标准
- 年龄范围
- 20 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged between 20-25 years
- •signed an approved Informed Consent Form, authorizing the participation in the trial and the use of the results of the trial for educational purposes and for the publication
- •the diagnosis of gingivitis stated clinically
- •at least one tooth with the diagnosis of dentin hypersensitivity stated clinically
排除标准
- •medical and pharmacotherapeutic histories that may compromise the protocol (pregnancy or breastfeeding, psychiatric disorders, allergies to toothpastes ingredients, eating disorders)
- •systemic conditions that are etiologic to dentin hypersensitivity (e.g., chronic acid regurgitation)
- •history of chemotherapy or radiotherapy
- •taking antibiotic, anti-inflammatory, or anti-coagulant medications 4 weeks prior to or after the baseline visit
- •oral mucosa pathology
- •periodontal surgery in the preceding 3 months
- •orthodontic appliance treatment within previous 3 months
- •teeth or supporting structures with any other painful pathology or defects
- •taking any other agents for DH management 4 weeks prior to or after the baseline visit
- •extensively restored teeth and those with restorations extending into the
- •cervical area
- •dental bleaching within previous 3 months
- •subject withdrawal of consent
- •subject is not compliant with study procedures
- •adverse Event that in the opinion of the Investigator would be in the best interest
- •of the subject to discontinue study participation
研究组 & 干预措施
Group 1 - toothpaste containing thermal water of Castera-Verduzan and 1450 ppm Sodium fluoride
Subjects will receive thermal water/sodium fluoride toothpaste (BUCCOTHERM® Sensitive Gums with Fluoride)
干预措施: BUCCOTHERM® Sensitive Gums with Fluoride (Drug)
Group 2 - toothpaste containing thermal water of Castera-Verduzan
Subjects will receive thermal water toothpaste (BUCCOTHERM® Sensitive Gums Fluoride-Free)
干预措施: BUCCOTHERM® Sensitive Gums Fluoride-Free (Drug)
结局指标
主要结局
Evaluation of DH according to Shiff sensitivity score
时间窗: 4 weeks after the baseline
First, the tooth is isolated by the cotton roll from the adjacent teeth. Next, a blast of air from a standard dental unit syringe at 60 ± 5 psi at 18-22 °C is directed onto the exposed middle 1/3 buccal surface for 1 s at a distance of approximately 10 mm. Then, each patient reports the sensitivity he/she sensed using Schiff Cold Air Sensitivity scale scored from 0 to 3: score "0" means no response, score "1" means response without request of discontinuation of stimulus, score "2" means response with request of discontinuation of stimulus, and score "3" means pain with request of discontinuation of stimuli. Lower scores indicate better results.
Evaluation of gingival inflammation by Modified Gingival Index (MGI)
时间窗: 4 weeks after the baseline
MGI is used to assess visual symptoms of gingivitis on facial and lingual surfaces of each scorable tooth (whole mouth). Two scores are recorded buccally/labially, two scores lingually/palatally. Values are presented as means across all tooth surfaces with minimum and maximum scores in agreement with minimum and maximum index values (i.e., 0-4). Scoring is performed using standard dental light:0=absence of inflammation,1=mild inflammation;slight change in color,little change in color; little change in texture of any portion of the marginal or papillary gingival unit,2=mild inflammation; criteria as above plus the entire marginal or papillar gingival unit,3=moderate inflammation;glazing, redness, edema, and/or hypertrophy of the marginal or papillary gingival unit,4=severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit,spontaneous bleeding,congestion,or ulceration. Lower scores indicate better results.
Evaluation of gingival inflammation by Bleeding Inde
时间窗: 4 weeks after the baseline
BI is used to assess bleeding elicited on probing as a measure of gingival condition. Gingivae are air dried and examiner assesses bleeding using a probe which is gently inserted into gingival crevice to depth of app 1 mm and run around tooth (angle of app 60 deg to long axis of tooth), gently stretching epithelium while sweeping from interproximal to interproximal along sulcular epithelium. BI is assessed on facial and lingual gingival surfaces of each scorable tooth (whole mouth). 3 scores are recorded buccally/ labially, 3scores lingually/ palatally. All scorable teeth in one quadrant are probed first (app 30 sec) before recording number of gingival units which bleed. Values are presented as means across all tooth surfaces with minimum and maximum scores in agreement with minimum and maximum index values (i.e., 0-2). BI score:0=no bleeding after 30 sec, 1=bleeding upon probing after 30 sec,2=immediate bleeding. Lower scores indicate better results.
次要结局
- Evaluation of oral hygiene level according to Navi-Rustogi index(4 weeks after the baseline)
- Evaluation of salivary pH(3 minutes after baseline (after toothbrushing))