跳至主要内容
临床试验/CTRI/2024/10/075446
CTRI/2024/10/075446已完成3 期

Assessing the efficacy of GuruNanda advance pulling oil versus Colgate® optic white® mouthwash in teeth whitening and overall oral hygiene improvement: double-blind, active & placebo-controlled, randomized comparative study

GuruNanda LLC2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年10月28日最近更新:

试验速览

阶段
3 期
状态
已完成
发起方
GuruNanda LLC
入组人数
90
试验地点
2
主要终点
1. Changes in VITA Shade Scale.

研究概览

简要总结

This study is based on the growing acknowledgment of oil pulling with coconut oil as a potentially effective adjunctive therapy in oral hygiene. Ayurvedic traditions have long advocated for oil pulling as a preventive measure for oral diseases and overall health enhancement. Recent research has corroborated these claims, demonstrating that coconut oil can significantly reduce plaque index, gingival index, and levels of pathogenic bacteria, largely attributed to its high lauric acid content. Lauric acid exhibits notable antimicrobial properties, including the disruption of bacterial cell membranes and the inhibition of microbial signal transduction, supporting its efficacy in oral health management.

Despite these promising findings, the integration of oil pulling or the use of oil-based mouthwashes, compared to water-based mouthwashes, into contemporary dental practice remains inadequately explored and lacks comprehensive, standardized evidence. Additionally, the use of essential oils in oral hygiene practices also lacks sufficient scientific validation. This study seeks to address these deficiencies by systematically assessing the impact of  MCT oil infused with select essential oils  on key oral health and hygine indicators,  such as plaque and gingival indices, whitening efficacy, and antimicrobial effectiveness. Additionally, the study will investigate its effects on systemic health by evaluating relevant biomarkers. The results will provide valuable insights into the potential incorporation of oil based mouthwash as a supplementary practice to established oral hygiene protocols, thereby enhancing preventive measures and expanding therapeutic options for both dental and systemic health.

This study aims to bridge the gap between traditional Ayurvedic practices and modern dental care by rigorously evaluating the efficacy of essential oil pulling. By examining its impact on oral health and hygiene indicators as well as relevant biomarkers for systemic health, the findings will contribute to evidence-based integration of oil pulling into contemporary oral hygiene practices, potentially advancing both preventive and therapeutic oral health strategies.

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
25.00 Year(s) 至 55.00 Year(s)(—)
性别
All

入选标准

  • 1.Healthy male and female aged 25 to 55 years (Both include)2.Individuals with generally healthy oral tissues, as confirmed by a comprehensive dental examination.
  • This includes no current or recent (within the last 6 months) periodontal treatment or significant oral diseases.3.Participants who have all incisors and canines in the upper and lower jaw.4.Individuals in good general health without any systemic conditions or medications that could affect oral health or interfere with the study treatments.5.Participants who provide written informed consent to participate in the study and comply with all study procedures and requirements.

排除标准

  • 1.Suspected alcohol or substance abuse e.g. amphetamines, benzodiazepines, cocaine, and marijuana opiates.
  • 2.Individuals with current alcohol or tobacco use.
  • 3.Females who are pregnant or breastfeeding.
  • 5.Significant unstable or uncontrolled medical condition which may interfere with a subjects participation in the study.
  • 6.Participated in tooth stain removal trials in the least 3 months.
  • 7.Individuals who are unable to adhere to the study protocol or have conditions that may interfere with compliance, including cognitive impairments or language barriers.
  • 9.Participants involved in concurrent studies with similar assessments or interventions.
  • 10.Participants experiencing severe dry mouth like xerostomia.

结局指标

主要结局

1. Changes in VITA Shade Scale.

时间窗: baseline, week 1 and week 2.

2. Changes in Macpherson’s Modified Stain Index.

时间窗: baseline, week 1 and week 2.

3. Changes in tooth sensitivity and gum discomfort using Wong Bakers Face Scale.

时间窗: baseline, week 1 and week 2.

次要结局

  • 1. Changes in Investigational Product on Plaque Index (PI) and Modified Gingival Index (MGI).(2. Changes in % mean reduction CFUs in Gram-positive and negative bacteria.)

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 Rajlaxmi Patil

Lokmanya Medical Research Centre

研究点 (2)

Loading locations...

相似试验