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临床试验/CTRI/2025/02/080408
CTRI/2025/02/080408尚未招募3 期

A Randomized, Multi-Centric, Comparative, Double Blinded Placebo controlled Clinical Study to evaluate the efficacy and safety Of Gurunanda Coco- Mint Oil Pulling Oral Rinse in Improving Tooth Shade (Whitening Efficacy)

GuruNanda LLC1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年2月25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
80
试验地点
1
主要终点
1. To assess improvement in VITA shade scale over various assessments.

研究概览

简要总结

80 Participants who will fulfill the inclusion and exclusion criteria will consider for the study

Objective: 1.To study the efficacy of Of Gurunanda Coco- Mint Oil Pulling Oral Rinse in Improving Tooth Shade

2.To assess the safety of Gurunanda Coco- Mint Oil Pulling Oral Rinse in Improving Tooth Shade

Study Design: Two-arm, parallel-group, randomized, Multi-Centric double blinded, Placebo Controlled trial

Primary Outcomes:

1.To assess improvement in VITA shade scale over various assessments.

2.Air Blast Hypersensitivity.

3.Examiner rates the response to stimulation of hypersensitive teeth using a jet of air. Response is rated on the Schiff cold Air sensitivity Scale.

4.To  observe the Enamel by Visual Inspection

5.To observe the Enamel by Tactile Examination using  dental probes, the dentist can feel the texture of the enamel by Mohs hardness scale.

6.Picture of pre and post assessment will be taken.

Secondary outcomes:

1.To assess the safety of the investigational product throughout the study period for any abnormal findings.

2.Additionally, the oral hard tissues will be assessed and abnormal finding questionnaire

Inclusion:(80 participants- 40 Each groups)

1.Systemically healthy adult subjects in the age group of 18-60 years

2.Tooth shade A2 or darker.

3.Good general health with no systemic conditions affecting oral health.

4.Presence of natural teeth with visible extrinsic stains or discoloration.

5.Willingness to avoid other whitening treatments during the study period.

6.Not wearing a clear aligner, retainer, and night guard.

Exclusion:

1.Subjects with mal-aligned teeth, wearing orthodontic appliances and removable partial dentures

2.Current use of medications causing tooth discoloration, such as tetracycline

3.Subjects with chronic or aggressive periodontitis

4.Tobacco consumers and smokers, betel chewers.

5.Subjects who are pregnant or lactating.

6.Subjects with hypersensitivity to any of the test products.

7.Subjects with pre-existing tooth sensitivity

8.Concurrent use of any other treatment for teeth whitening or sensitivity

9.Concurrent participation in any other clinical trial or study involving teeth whitening or sensitivity assessment.

10.Severe enamel defects or intrinsic discoloration unrelated to staining.

11.Prior participation in a similar study within the past six months.

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

  • 1.who prefer to improve teeth shade cosmetically and who would want to maintain oral hygiene and to comply with the study procedures.
  • 2.Tooth shade A2 or darker.
  • 3.Good general health with no systemic conditions affecting oral health.
  • 4.Presence of natural teeth with visible extrinsic stains or discoloration.
  • 5.Willingness to avoid other whitening treatments during the study period.
  • 6.Ability to provide informed consent.
  • 7.Compliance with study protocols, including scheduled visits and post-treatment care.
  • 8.Not wearing a clear aligner, retainer, and night guard.

排除标准

  • 1.Subjects with mal-aligned teeth, wearing orthodontic appliances and removable partial dentures.
  • 2.Subjects with chronic or aggressive periodontitis who underwent recent whitening intervention.
  • 3.Tobacco consumers and smokers, betel chewers.
  • 4.Subjects who are pregnant or lactating.
  • 5.Subjects with hypersensitivity to any of the test products.
  • 7.Concurrent use of any other treatment for teeth whitening or sensitivity.
  • 8.Concurrent participation in any other clinical trial or study involving teeth whitening or sensitivity assessment.
  • 9.Severe enamel defects or intrinsic discoloration unrelated to staining.
  • 10.Prior participation in a similar study within the past six months.
  • 11.Current use of medications causing tooth discoloration, such as tetracycline.

结局指标

主要结局

1. To assess improvement in VITA shade scale over various assessments.

时间窗: Visit 1(Day1), Visit 2(week2), Visit 3(week4), Visit4(week6)

2.Air Blast Hypersensitivity.

时间窗: Visit 1(Day1), Visit 2(week2), Visit 3(week4), Visit4(week6)

3.Examiner rates the response to stimulation of hypersensitive teeth using a jet of air(Constant stimulus on the basis of duration, pressure, temperature and distance from target).Response is rated on the Schiff cold Air sensitivity Scale.

时间窗: Visit 1(Day1), Visit 2(week2), Visit 3(week4), Visit4(week6)

4.To observe the Enamel by Visual Inspection

时间窗: Visit 1(Day1), Visit 2(week2), Visit 3(week4), Visit4(week6)

5.To observe the Enamel by Tactile Examination using dental probes, the dentist can feel the texture of the enamel by Mohs hardness scale.

时间窗: Visit 1(Day1), Visit 2(week2), Visit 3(week4), Visit4(week6)

6.Picture of pre and post assessment will be taken.

时间窗: Visit 1(Day1), Visit 2(week2), Visit 3(week4), Visit4(week6)

次要结局

  • To assess the safety of the investigational product throughout the study period for any abnormal findings on gingival and mucosal tissues, dental hard tissues, including but not limited to the gingiva((free and attached), hard and soft palate, oropharynx/uvula, buccal mucosa, tongue, floor of the mouth, labial mucosa, mucobuccal/mucolabial folds, lips, and perioral area.)
  • Additionally, the oral hard tissues will be assessed and abnormal finding questionnaire: burning mouth, altered taste, sore mouth,(ulcers, change in gum colours, sensitivity etc.)

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 K T Magesh MDS

SRM Medical College Hospital and Research Centre

研究点 (1)

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