NCT05483062已完成不适用
Effectiveness of Toothpaste Containing the Active Ingredient of Galla Chinensis Extract on Treating Dentin Hypersensitivity '' A Randomized Clinical Trial ''
Minia University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2021年5月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change of pain level in response to stimuli
研究概览
简要总结
This clinical trial was conducted to compare the desensitizing effect of toothpaste containing the active ingredient of an extract of Galla chinensis and toothpaste containing fluoride in patients with dentin hypersensitivity.
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years.
- •Overall good oral hygiene status.
- •Participants show tooth neck abrasion or gingival retraction.
- •Patients have subjective dentin hypersensitivity (at least 1 tooth) after using airflow.
- •No history of periodontal treatment, including periodontal surgery, in the past year.
- •Written informed consent
排除标准
- •Patient with severe periodontitis or severe erosion damage.
- •Patients with a compromised medical history, or had received therapeutic irradiation to the head and neck region.
- •Medically compromised patients where pain levels would be compromised.
- •If analgesics or antibiotics have been administrated by the patient during the past 12 hours preoperatively as it might alter their pain perception.
- •Patients reporting bruxism or clenching in order to avoid further pressure on an already hypersensitive tooth inducing subsequent irritation and inflammation.
- •Teeth that show association with acute periapical abscess and swelling.
- •Greater than grade I mobility or pocket depth greater than 5mm.
- •Non-restorable teeth or hopeless teeth.
- •Immature teeth.
- •Radiographic evidence of external or internal root resorption.
- •Alcoholic and smoker patients.
- •Pregnant or breastfeeding ladies.
- •Patients having physical disabilities, or who are unable to brush their teeth
- •Patients who have a history of allergies to any personal oral care product or ingredient, or who are taking anti-inflammatory drugs within the previous month.
- •Individuals who had sensitive teeth but with one of the following conditions will be excluded from the study, teeth with large restorations, abutment of teeth of removable partial dentures, dental caries, enamel cracks, leakage of fillings or other restorations, cracked 23
- •teeth, dental pulp lesions, dental abscesses, pulpitis, and atypical facial pain.
- •Patients had participated in a clinical trial within 6 months before commencement of this trial.
- •Patients unable to return for recall appointment.
结局指标
主要结局
Change of pain level in response to stimuli
时间窗: 6 months follow up
Teeth were evaluated at baseline (T0), 1week (T1), 2 weeks (T2), 4 weeks (T3), 3 months (T4), and 6 months (T5) after using different types of toothpastes using Visual Analog Scale (VAS) scoring from 0-10 while 0 mean no pain and 10 severe pain by sensitivity tests (schiff test )
次要结局
未报告次要终点
研究者
Ibram ibrahim morkous henein
principal investigator
Minia University
研究点 (1)
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