The Use of 8% L-Arginine/Calcium Carbonate Containing Toothpaste in Comparison to Strontium Acetate Containing Toothpaste in Management of Hypersensitive Dentine in Chronic Periodontitis Patients : A Randomized-controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- change from baseline Pain (sensetivity) at 8 weeks
研究概览
简要总结
Dentinal hypersensitivity [DH] is a common condition in daily practice, especially in patients who have abrasion, attrition, gingival recession and erosion of teeth. It can affect individuals in the age range of 20-50 years.In a recent systematic review, it was reported that no gold standard treatment modality for dentin hypersensitivity has been established Thus there is a need to evaluate new formulations in different settings and in different populations and to compare those to commonly used agents seeking better results in pain relief for our patients. Studies showed that dentifrice formulations containing 8% arginine in combination with calcium carbonate and fluoride have the ability to plug dentinal tubules, by clumping of both arginine and calcium carbonate that bind with the negatively charged dentin . Aim of the study is to clinically evaluate toothpaste containing 8% arginine, calcium carbonate, and sodium mono-fluorophosphate, in comparison to toothpaste, containing 8% strontium acetate and NaF on the relief of DH in chronic periodontitis patients.
详细描述
- Each eligible patient will be given a number.
- All eligible patients will receive mechanical debridement in 1 or 2 sessions within 1 week before final evaluation.
- The hypersensitive teeth will be isolated with cotton rolls, and stimuli will be applied to each tooth for final evaluation after scaling and debridement.
- Air Sensitivity scale is used to assess sensitivity to air blast, while cold water test and tactile test will be held and assessed by Visual Analog Scale (VAS) , which score from 0 (no pain) to 10 (intense pain).
- Patients will be handed a 30ml. white package written on it the previously assigned number to them and instructed to brush twice daily with the assigned toothpaste by a soft-bristled toothbrush for 8 weeks, with several returns to the clinic for re-evaluation and to take the refill of the assigned number of toothpaste.
- Air blast sensitivity score and VAS will be evaluated again weekly and till the end of the evaluation period.
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
similar empty tubes filled by the control and intervention toothpaste then sealed and given a number only.The patients,care provider,outcome assessor and investigator are blinded to the intervention and control toothpaste.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Slight to moderate chronic periodontitis patients diagnosed according to criteria of (Parameter on chronic periodontitis with slight to moderate loss of periodontal support.
- •American Academy of Periodontology., 2000) as follows : Probing pocket depths up to 6mm Clinical attachment loss (CAL) up to 4mm Class I (incipient) furcation involvement Radiographic evidence of bone loss.
- •At least 2 teeth presenting hypersensitive areas on facial surfaces of teeth with score 2 or 3 on the air sensitivity scale (Pepelassi et al., 2015)
- •Provision of written informed consent
排除标准
- •Chipped teeth.
- •Defective restorations.
- •Deep dental caries or large restorations showing pulpal response.
- •Ongoing treatment with anti-inflammatory drugs.
- •Ongoing treatment for tooth hypersensitivity.
- •Uncontrolled metabolic diseases.
- •Psychiatric disorder.
研究组 & 干预措施
Strontium acetate toothpaste
All eligible patients will receive mechanical debridement in 1 or 2 sessions within 1 week before final evaluation.
干预措施: use of strontium acetate toothpaste (Other)
Arginine/calcium carbonate toothpaste
All eligible patients will receive mechanical debridement in 1 or 2 sessions within 1 week before final evaluation.
干预措施: 8% L-Arginine/calcium carbonate containing toothpaste (Other)
结局指标
主要结局
change from baseline Pain (sensetivity) at 8 weeks
时间窗: baseline and after 8 weeks
This will be assessed using VAS that will be determined immediately before product use and then after 8 weeks of daily brushing with the test and control toothpastes following stimulus application using Visual Analog Scale (VAS)
次要结局
- Probing pocket depth(baseline and after 8 weeks)
- Gingival recession (GR)(baseline and after 8 weeks)
研究者
Abdallah Hassan Mostafa
DR. Abdallah Hassan
Cairo University