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临床试验/CTRI/2025/02/081110
CTRI/2025/02/081110尚未招募3 期

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 in reducing the sensitivity of teeth and gums.

GuruNanda LLC2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年2月28日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
GuruNanda LLC
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).

研究概览

简要总结

To assess the Efficacy and safety GURUNANDA OIL pulling oral rinse in reducing the sensitivity of teeth and gums.

Objective:1.To study the efficacy of Gurunanda Oil Pulling Oral Rinse in reducing the sensitivity of teeth and gums and                                compare with Listerine Sensitivity Mouthwash and placebo.

2.To assess the safety of Gurunanda Oil Pulling Oral Rinse by monitoring the occurrence of any adverse effects.

Study Design: Three-arm, parallel-group, randomized, multi-centric, double blinded, active comparator & placebo-controlled

Primary Outcomes:

1.Objective assessment of the sensitivity of hard tooth tissue, an index of the intensity of teeth hyperesthesia (IIGZ).

2.A visual analogue scale is proposed for self-assessment by the participant of the level of pain.

3.To evaluate the cleaning effect of studied products Oral Hygiene Index Simplified (OHI-S).

4.Air Blast Hypersensitivity.

5.Examiner rates the response to stimulation of hypersensitive teeth using a jet of air  Response is rated based on the Schiff Cold Air Sensitivity Scale Response is rated based on the Schiff Cold Air Sensitivity Scale.

6.Reductions in extrinsic tooth stain area and extrinsic tooth stain intensity.

7.Photographic assessment of dental hygiene.

Secondary Outcomes:

1.Participant and Investigator Feedback will be obtained before enrollment and after completion of the study.

2.Adverse event monitoring.

Inclusion (90 participants - Each Group 45 participants)

1.Presence of a minimum of 20 teeth.

2.Presence of tooth sensitivity.

3.Adequate oral hygiene and no sign of oral neglect.

4.Qualifying response to the Air Blast Stimuli by Schiff Cold Air Sensitivity Scale.

5.Use of a non-desensitizing dentifrice for one month prior to entry into the study.

Exclusion:

1.Professional teeth cleaning and whitening less than 30 days before the examination.

2.Carrying out other dental procedures, including orthodontic and surgical, less than 30 days prior to the study.

3.The use of analgesic agents less than 7 days prior to inclusion

4.Untreated dental caries or active periodontal disease .

5.Presence of cracked, chipped, or fractured teeth.

6.Severe enamel loss, dentin exposure, or pulpitis

7.Teeth whitening, scaling, or polishing within the past 4–6 weeks.

8.Recent restorations or oral surgeries that could influence sensitivity.

9.Regular use of desensitizing toothpaste or treatments within the past 4 weeks

10.Use of prescription fluoride treatments or other dental products specifically targeting sensitivity

11.Conditions affecting oral health, such as diabetes, GERD.

12.Excessive consumption of acidic foods or beverages.

13.Heavy tobacco or alcohol use that could affect oral health or study results.

14.History of bruxism, clenching, or other habits that could increase tooth wear.

15.Known allergies to any components of the products being tested.

16.Conditions or medications that might interfere with the perception of sensitivity.

17.Participation in any other clinical study or test panel within one month prior to entry into the study.

18.History of Hepatitis B or C, HIV infection.

19.Chemotherapy, radiation therapy or cytokine therapy less than 5 years before being included in the study.

20.Pregnant or lactating participants.

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 50.00 Year(s)(—)
性别
All

入选标准

  • 1.Presence of a minimum of 20 teeth 2.Presence of tooth sensitivity 3.Adequate oral hygiene and no sign of oral neglect 4.Qualifying response to the Air Blast Stimuli by Schiff Cold Air Sensitivity Scale 5.Use of a non-desensitizing dentifrice for one month prior to entry into the study.

排除标准

  • 1.Professional teeth cleaning and whitening less than 30 days before the examination.
  • 2.Carrying out other dental procedures, including orthodontic and surgical, less than 30 days prior to the study.
  • 3.The use of analgesic agents less than 7 days prior to inclusion 4.Untreated dental caries or active periodontal disease .
  • 5.Presence of cracked, chipped, or fractured teeth.
  • 6.Severe enamel loss, dentin exposure, or pulpitis 7.Teeth whitening, scaling, or polishing within the past 4–6 weeks.
  • 8.Recent restorations or oral surgeries that could influence sensitivity.
  • 9.Regular use of desensitizing toothpaste or treatments within the past 4 weeks 10.Use of prescription fluoride treatments or other dental products specifically targeting sensitivity 11.Conditions affecting oral health, such as diabetes, GERD.
  • 12.Excessive consumption of acidic foods or beverages.
  • 13.Heavy tobacco or alcohol use that could affect oral health or study results.
  • 15.Known allergies to any components of the products being tested.
  • 17.Participation in any other clinical study or test panel within one month prior to entry into the study.
  • 18.History of Hepatitis B or C, HIV infection.
  • 19.Chemotherapy, radiation therapy or cytokine therapy less than 5 years before being included in the study.
  • 20.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).

时间窗: Visit 1(Day1), Visit 2(week1), visit 3(week2), visit 4(week3), visit 5(week4)

2.A visual analogue scale is proposed for self-assessment by the participant of the level of pain.

时间窗: Visit 1(Day1), Visit 2(week1), visit 3(week2), visit 4(week3), visit 5(week4)

3.To evaluate the cleaning effect of studied products Oral Hygiene Index Simplified (OHI-S).

时间窗: Visit 1(Day1), Visit 2(week1), visit 3(week2), visit 4(week3), visit 5(week4)

4.Air Blast Hypersensitivity.

时间窗: Visit 1(Day1), Visit 2(week1), visit 3(week2), visit 4(week3), visit 5(week4)

5.Examiner rates the response to stimulation of hypersensitive teeth using a jet of air Response is rated based on the Schiff Cold Air Sensitivity Scale Response is rated based on the Schiff Cold Air Sensitivity Scale.

时间窗: Visit 1(Day1), Visit 2(week1), visit 3(week2), visit 4(week3), visit 5(week4)

6.Reductions in extrinsic tooth stain area and extrinsic tooth stain intensity.

时间窗: Visit 1(Day1), Visit 2(week1), visit 3(week2), visit 4(week3), visit 5(week4)

7.Photographic assessment of dental hygiene.

时间窗: Visit 1(Day1), Visit 2(week1), visit 3(week2), visit 4(week3), visit 5(week4)

次要结局

  • 1.Participant and Investigator Feedback will be obtained before enrollment and after completion of the study.(2.Adverse event monitoring.)

研究者

发起方
GuruNanda LLC
申办方类型
Pharmaceutical industry-Global
责任方
Principal Investigator
主要研究者

Dr R C Satish Kumar

SRM Medical College Hospital and Research Centre

研究点 (2)

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