Therapeutic Application of Coconut Oil in Oral Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Bleeding on probing in percentage
研究概览
简要总结
The scientific literature has verified that coconut oil has properties that open perspectives for its application in order to maintain oral health and, in particular, for the treatment of different oral pathologies.
Thus, the purpose of this project is summarized in the following objectives:
- Determine in vitro the biocompatibility of coconut oil.
- Determine in vivo the clinical effect of coconut oil as an adjunct treatment for periodontal disease.
详细描述
Periodontal disease is one of the most prevalent pathologies in humans. In the latest survey on Oral Health in Spain by the Council of Dentists of Spain, it is determined that between 85-94% of the Spanish population over 35 years of age has some problem related to their gums. Severe periodontal diseases, which can lead to tooth loss, affect 15%-20% of middle-aged adults (35-44 years).
One of the most common products used as an antibacterial agent to treat different oral conditions is chlorhexidine and its derivatives. Chlorhexidine exists commercially in different preparations such as mouthwash, toothpaste and gel, among others. Their main drawbacks are that in the long term they stain the teeth and can cause oral lesions, burning sensation and a deterioration in the sensation of taste.
Likewise, various antibiotics, both local and systemic, are used as an adjuvant in the treatment of certain types of gum diseases. Due to the rapid increase in bacterial resistance due to the extensive use of antibiotics, it is important to evaluate alternative antimicrobial agents that can help reduce the use of antibiotics.
Both the coconut and the plant from which this fruit comes are widely used in traditional medicine. Furthermore, the scientific literature on the biological effect of different presentations of this plant (alcoholic extract of coconut shell, coconut water, coconut oil, etc.) has shown, among others, anti-inflammatory activities, analgesic, antioxidant, antifungal, antimicrobial and even antitumor.
There are several hypotheses that suggest that the benefits of using coconut oil can be attributed to the presence of lauric acid, which has the ability to destroy the lipid membrane of microorganisms such as the herpes virus and Gram positive and Gram negative bacteria. Likewise, the viscosity of the oil could inhibit bacterial adhesion and plaque accumulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of legal age (18 years) affected by periodontitis with the ability to read, understand and sign the informed consent after having explained the nature of the study, with a willingness to follow protocol requirements
- •Diagnosed with periodontal disease stages II, III and IV and grades B and C
- •Minimum of 16 natural teeth
排除标准
- •Patients who have been treated with antibiotics in the last 4 weeks and who are currently being treated with antibiotics.
- •Patients who regularly use gum or candies with xylitol, coconut or coconut derivatives.
- •Patients who have received dental cleaning within the last 6 months.
- •Pregnant and breastfeeding patients,
- •Patients with allergies to coconut, coconut-derived products and chlorhexidine
- •Patients with uncontrolled diabetes, uncontrolled high blood pressure, bleeding disorders, liver or kidney disease, heart disease, active cancer, active infectious diseases (other than periodontitis) and patients with a history of local irradiation therapy in the head/neck area.
研究组 & 干预措施
Coconut oil
Participants will perform 10-minute vigorous full-mouth rinses once daily after night (2-minute brushing time) brushing. The amount of coconut oil used will be one teaspoon (5 ml). Each participant will be given a container with volume measurement markings. Patients will be provided with the same toothbrush and toothpaste for their dental hygiene 2 times a day. Participants will be asked not to use products containing xylitol, tea, coffee, systemic antibiotics, or topical fluoride during the study. Any participant who violates these rules will be excluded from the study.
Reevaluation and sampling will be done after 30 days.
干预措施: Coconut Oil (Dietary Supplement)
Chlorhexidine
Participants will vigorously rinse their entire mouth with Chlorhexidine 0.12% daily after morning (2 minute brushing time) and evening brushing. The amount of chlorhexidine used will be one teaspoon (5 ml). Each participant will be given a container with volume measurement markings. Patients will be provided with the same toothbrush and toothpaste for their dental hygiene 2 times a day. Participants will be asked not to use products containing xylitol, tea, coffee, systemic antibiotics, or topical fluoride during the study. Any participant who violates these rules will be excluded from the study.
Reevaluation and sampling will be done after 30 days.
干预措施: Chlorhexidine mouthwash (Drug)
Water
Participants will vigorously rinse their entire mouth with water daily after morning (2 minute brushing time) and evening brushing. The amount of water used will be one teaspoon (5 ml). Each participant will be given a container with volume measurement markings. Patients will be provided with the same toothbrush and toothpaste for their dental hygiene 2 times a day. Participants will be asked not to use products containing xylitol, tea, coffee, systemic antibiotics, or topical fluoride during the study. Any participant who violates these rules will be excluded from the study.
Reevaluation and sampling will be done after 30 days.
干预措施: Water mouthwash (Other)
结局指标
主要结局
Bleeding on probing in percentage
时间窗: At 0 days, 30 days and 60 days
To evaluate the effect of treatment on reduction of bleeding on probing
Plaque index in percentage
时间窗: At 0, 30 and 60 days
To evaluate the effect of treatment on reduction of plaque accumulation
Probing depth in mm
时间窗: At 0 days, 30 days and 60 days
To evaluate the effect of treatment on probing depth reduction.
Volatile compounds in breath in ppm of sulphur compounds
时间窗: At 0, 30 and 60 days
To evaluate the effect of treatment on the presence of sulphur compounds present on breath
Type of bacteria present on samples from saliva and crevicular fluid using Illumina SBS (Sequencing by synthesis)
时间窗: At 0, 30 and 60 days
To evaluate the effect of treatment on the oral microbiome
次要结局
- Patient perception using Visual Analog Scale(At 0, 30 and 60 days)
- Tooth color change measured with the VITA score(At 0, 30 and 60 days)
研究者
Simón Pardiñas López
Principal Investigator
Instituto de Investigacion Biomedica de A Coruna