A Randomized, Multi-centric, Double blinded three arm, Placebo and Active Controlled parallel group comparative clinical trial to assess the efficacy and safety of Gurunanda Oil Pulling Oral Rinse with Ashwagandha & Neem in reducing the sensitivity of teeth and gums.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- 1.Objective assessment of the sensitivity of hard tooth tissue, an index of the intensity of teeth hyperesthesia (IIGZ) will be used
研究概览
简要总结
The participants will be sequentially and randomly assigned the groups according to the computer -generated code.
Group 1- 30 subjects- GuruNanda Oil Pulling Oral Rinse with Ashwagandha and Neem, once daily for 4 weeks
Group 2- 30 subjects- Listerine Sensitivity Mouhtwash
Group 3- 30 subjects- Placebo Oral Rinse
Primary Outcome
-
Objective Assessment of the sensitivity of hard tooth tissue, an index of the intensity of teeth hyperesthesia (IIGZ)
-
A Visual Analogue scale is proposed for self-assessment by the participant of the level of pain in the samples
-
To evaluate the cleaning effect of studied products Oral Hygiene Index Simplified (OHI-S)
-
Air Blast Hypersensitivity (Baseline to 4 weeks)
-
Reductions in extrinsic tooth stain area and extrinsic tooth stain intensity
-
Photographic Assessment of dental Hygiene
Secondary Outcome
-
Participant and Investigator Feedback
-
Adverse event monitoring
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants aged 18 to 50 years.
- •Presence of a minimum of 20 teeth.
- •3.Presence of tooth sensitivity (index of the intensity of teeth hyperesthesia, IIGZ score greater than 2).
- •4.Adequate oral hygiene and no signs of oral neglect.
- •Qualifying response to the Air Blast stimuli as defined by a score of 2 or 3 on the Schiff Cold Air Sensitivity Scale.
- •Use of a non-desensitizing dentifrice for one month prior to entry into the study.
- •Participant is willing to provide informed consent and is willing to participate in all procedures and follow up evaluations necessary to complete the study 7.
排除标准
- •Professional teeth cleaning and whitening less than 30 days before the examination.
- •Carrying out other dental procedures, including orthodontic and surgical, less than 30 days prior to the study, or the need to carry out them during the study period.
- •The use of analgesic agents less than 7 days prior to inclusion.
- •Untreated dental caries or active periodontal disease
- •Presence of cracked, chipped, or fractured teeth.
- •Severe enamel loss, dentin exposure, or pulpitis
- •Teeth whitening, scaling, or polishing within the past 4–6 weeks.
- •Recent restorations or oral surgeries that could influence sensitivity.
- •Regular use of desensitizing toothpaste or treatments within the past 4 weeks
- •Use of prescription fluoride treatments or other dental products specifically targeting sensitivity
- •Conditions affecting oral health, such as diabetes, Sjögren’s syndrome, or GERD
- •Excessive consumption of acidic foods or beverages
- •Heavy tobacco or alcohol use that could affect oral health or study results.
- •Known allergies to any components of the products being tested.
- •Conditions or medications that might interfere with the perception of sensitivity (e.g., pain medications)
- •History of Hepatitis B or C, HIV infection.
- •Chemotherapy, radiation therapy or cytokine therapy less than 5 years before being included in the study
- •Pregnant or lactating participants.
结局指标
主要结局
1.Objective assessment of the sensitivity of hard tooth tissue, an index of the intensity of teeth hyperesthesia (IIGZ) will be used
时间窗: Baseline,Week 1, Week 2 , Week 3 and Week 4
2.A visual analogue scale is proposed for self-assessment by the participant of the level of pain in the samples, where the values from 1 to 3 corresponded to the light intensity of pain, from 4 to 6 points - moderate, and 7 or higher – strong
时间窗: Baseline,Week 1, Week 2 , Week 3 and Week 4
3.To evaluate the cleaning effect of studied products Oral Hygiene Index Simplified (OHI-S) [ Time Frame: Baseline to 4 weeks]
时间窗: Baseline,Week 1, Week 2 , Week 3 and Week 4
4. Air Blast Hypersensitivity [ during each visit over 1-4 weeks]
时间窗: Baseline,Week 1, Week 2 , Week 3 and Week 4
5. Examiner rates the response to stimulation of hypersensitive teeth using a jet of air (constant stimulus based on duration, pressure, temperature, distance from target). Response is rated based on the Schiff Cold Air Sensitivity Scale.
时间窗: Baseline,Week 1, Week 2 , Week 3 and Week 4
6. Reductions in extrinsic tooth stain area and extrinsic tooth stain intensity.
时间窗: Baseline,Week 1, Week 2 , Week 3 and Week 4
7. Photographic Assessment
时间窗: Baseline,Week 1, Week 2 , Week 3 and Week 4
次要结局
- Participant and Investigator Feedback will be obtained before enrollment and after completion of the study(Adverse event monitoring)
研究者
Dr Aravindhan R Ph.D
SRM Medical College Hospital and Research Centre