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)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 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
Dr K T Magesh MDS
SRM Medical College Hospital and Research Centre
