Efficacy of Extra Virgin Cold Pressed Coconut Oil With Peppermint Essential Oil as Natural Cleaning Agent for Oral Hygiene Routine on Salivary Streptococcus Mutant Levels Versus The Conventional Oral Hygiene Methods in High Caries Risk Patients: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in the bacterial count will be assessed
研究概览
简要总结
This randomized clinical trial will be conducted to investigate the efficacy of an innovative tooth cleaning agent extra virgin coconut oil with peppermint essential oil by oil pulling and toothbrushing with oil on reducing salivary Streptococcus mutans levels, tooth decay and plaque buildup versus on the counter toothpaste in high caries risk patients.
详细描述
Everyday use of dental health care products has increased. Therefore, there is a legitimately increased interest of healthcare clinicians and consumers in substances added to the toothpaste with the intention to improve their performance and potential benefits and risks that may arise from it. As there are harmful products in the toothpaste for instance: (Fluoride, Sodium Lauryl Sulphate (SLS), Sodium Saccharin and Triclosan which is assumed that it because local reaction includes oral mucosa irritation and desquamation (stomatitis, glossitis, gingivitis, buccal mucositis), while systemic ones are allergic and acute or chronic toxic reactions. Rational Harmful products in the toothpaste for instance: (Fluoride, Sodium Lauryl Sulphate (SLS), Sodium Saccharin and Triclosan which is assumed that it because local reaction includes oral mucosa irritation and desquamation (stomatitis, glossitis, gingivitis, buccal mucositis), while systemic ones are allergic and acute or chronic toxic reactions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Double-blind study
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients will be recruited in this study, will be medically free.
- •Age range 20-50 years
- •Patients with high caries risk assessment (0- 30% high caries risk) according to Cariogram - a multifactorial risk assessment model for dental caries.
- •Non-Smoking patients
- •Not under antibiotic therapy either at the time of the study or up to the last month before the start of the study.
- •Male or Female patients
- •Patients have brushing habits
- •No Fixed orthodontic treatment
- •No active or untreated caries
- •Patients on non-cariogenic diet
排除标准
- •Patients with a compromised medical history.
- •Patients with low caries risk assessment according to Cariogram - a multifactorial risk assessment model for dental caries.
- •Patients with severe or active periodontal disease.
- •Patients with a history of allergy to any of the drugs or chemicals will be used in the study.
- •Patients on any antibiotics during the past month.
- •Smoking patient
- •Patients with very low saliva secretion xerostomia less than 0.5ml stimulated saliva /min score 3 according to Cariogram
- •Pregnant female patient
- •No brushing habits
- •Fixed orthodontic treatment
- •Active or untreated caries
- •Patients on cariogenic diet
结局指标
主要结局
Change in the bacterial count will be assessed
时间窗: T0: Baseline. T1: After one month. T2: After three months
The measuring test:Colony forming unit, The measuring units : Cfu/mm2 (Prabakar et al., 2018)
Change in the salivary pH will be assessed
时间窗: T0: Baseline. T1: After one month. T2: After three months
The measuring test: Digital pH meter, The measuring unit : Scoring system, (Sondos et al., 2019) (ordinal)
Change in the Plaque index will be assessed Löe-Silness (Loe 1963)
时间窗: T0: Baseline. T1: After one month. T2: After three months
The measuring unit : Plaque index The oral hygiene and plaque amount will be estimated using a mirror and graduated periodontal probe in accordance with Silness and Löe plaque index, which assessed the amount of plaque in the cervical part of the tooth.The Plaque Index System * (0) No plaque * (1) A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may be seen in situ only after application of disclosing solution or by using the probe on the tooth surface. * (2) Moderate accumulation of soft deposit s within the gingival pocket, or the tooth and gingival margin which can be seen with the naked eye. * (3) Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin. Löe-Silness (Loe 1963) (Sreenivasan et al.,2016), The Measuring units : Scoring system (ordinal)
Change in the actual chance to avoid new lesion will be assessed
时间窗: T0: Baseline. T1: After one month. T2: After three months
The Measuring test: Cariogram Model (Karabekiroğlu et al 2017), The Measuring units : Percentage
次要结局
- Change in the Bacterial virulence will be assessed(T0: Baseline. T1: After one month. T2: After three months)
研究者
Asmaa Mohamed Reda Ahmed Ali
Assistant lecture
Cairo University