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临床试验/NCT03839719
NCT03839719已完成不适用

Efficacy of Ocimum Sanctum as a Pre-procedural Mouth Rinse in Reducing Aerosol Contamination Produced by Ultrasonic Scaler: a Clinical and Microbiological Study.

Government College of Dentistry, Indore2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年1月9日最近更新:
适应症

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
2
主要终点
Counting of the colony-forming units (CFU)

研究概览

简要总结

  • Periodontal disease- Inflammatory, Multifactorial, and Threshold disease. Periodontal disease is a highly prevalent dental disease, an almost 100% prevalence in developing countries.
  • Non-surgical periodontal includes scaling and root planing (SRP) an essential part of successful periodontal therapy.
  • The spread of infection through aerosol and splatter has long been considered one of the main reason for the possible transmission of infectious agents and their ill effects on The Health of patients and Dental Health care Professionals.
  • Aerosols are generated during Tooth preparation/Rotary instrument/ air abrasion/Air-water syringe, Ultrasonic scaler, and while doing Air polishing.
  • Studies have also reported an association of these aerosols with Respiratory infections, Ophthalmic and Skin infections, Tuberculosis, and Hepatitis B. current research suggests that having patients use an antimicrobial rinse before treatment may decrease microbial aerosols.
  • Chlorhexidine mouthwash is regarded as Gold Standard mouthwash but, have many local side effects including have many local side effects including extrinsic tooth and tongue brown staining, taste disturbance, enhanced supragingival calculus formation, less commonly, desquamation of oral mucosa, and even liver damage in rats.
  • In the emerging era of pharmaceuticals, herbal medicines with their naturally occurring active ingredients offer a gentle and enduring way for the restoration of health by the least harmful method.
  • Ocimum Sanctum (Tulsi) is known as THE QUEEN OF HERBS effective in reducing plaque accumulation, gingival inflammation, and bleeding & has no side effects as compared to Chlorhexidine. Very few studies which can be counted on fingers have been conducted worldwide in this direction, globally showing their beneficial effects.

详细描述

The spread of infection through aerosol and splatter has long been considered one of the main reason for the possible transmission of infectious agents and their ill effects on the health of patients and dental health care professionals. Aerosol and splatter are a concern in dentistry because of their potential effects on the health of immuno-compromised patients and of dental personnel. These aerosols may be inhaled into the lungs to reach the alveoli or may come in contact with the skin or mucous membranes. Most of the aerosols produced during treatment procedures have a diameter of 5μm or less, and these can cause respiratory or other health problems because they can penetrate into, and remain within the lungs. The oral cavity consists of billions and billions of microorganisms, which can get transmitted from one person to another through water contamination, surface contact or through aerosols. Aerosols are generated during tooth preparation with a rotary instrument or air abrasion, during the use of an air-water syringe, ultrasonic scaler, and while doing air polishing. Miller (1976) found that aerosols generated from patients' mouths contained up to a million bacteria per cubic foot of air.

All health care professionals including the dentists, dental hygienists, and nurses can get exposed to microorganisms present in patients' blood, saliva and from instruments, which can lead to cross infections. The oral cavity harbors numerous bacteria and viruses from the respiratory tract, dental plaque, and oral fluids. Viruses which are present in aerosols such as human immunodeficiency virus hepatitis B can penetrate the conjunctiva, respiratory tract of clinician, assistant, and patients. In addition to this, some viruses such as mumps, rubella, and influenza also pose a serious risk to health care professionals. Any dental procedure that has the potential to aerosolize saliva will cause contamination of air with organisms from some or all of these sources. Other studies have also reported an association of these aerosols with respiratory infections, ophthalmic and skin infections, tuberculosis, and hepatitis B. Current research suggests that having patients use an antimicrobial rinse before treatment may decrease microbial aerosols.

Chlorhexidine gluconate, a bisbiguanide, is considered to be the gold standard of antimicrobial rinses because of broad-spectrum antibacterial activity but, it also has some side effects, notably tooth staining, taste alteration, enhanced supragingival calculus formation and less commonly desquamation of the oral mucosa. Also other then Chlorhexidine Providone iodine and essential oils are commonly used as mouthrinse.

In the emerging era of pharmaceuticals, herbal medicines with their naturally occurring active ingredients offer a gentle and enduring way for the restoration of health by the least harmful method. Herbal medicine is both promotive and preventive in its approach. Also, herbal mouth rinses with their natural ingredients offer a safe and effective option as mouthrinse.

The herbal mouthwash used in this study is made from natural herb extracts of Ocimum sanctum. Ocimum sanctum is commonly known as 'Tulsi' and popularly known as 'The Queen of Herbs', and the "Mother Medicine of Nature" due to its perceived medicinal qualities. Tulsi extract has been widely used in traditional medicine and human clinical trial without significant side effects. Scientific investigations during the last several decades have shown that various parts of Ocimum sanctum, including leaves, stem, root, flowers, and seed, have a plethora of biological and pharmacological activities, including antioxidant, anti-inflammatory, antiallergic, immunomodulatory, antimicrobial etc.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

This single-center, double-masked, placebo-controlled study was conducted over a period of 02 months. The participants and investigator are blinded about mouthrinse use and assigned quadrant.

Then Ultrasonic scaling was done in the 1st and 4th quadrant without any mouth rinse and Ultrasonic scaling is done in the 2nd and 3rd quadrant by giving either OC/CHX/Placebo mouth rinse

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Cases with Generalized Chronic Gingivitis or cases with mild
  • Generalized Chronic Periodontitis patients of any sex.
  • Systemically healthy individuals.
  • Patient having ≥ 20 teeth.
  • Patients in the age group of 18-40 years, who abide by approved protocol guidelines, and are ready to give written informed consent.

排除标准

  • Any known systemic disease which has effects on periodontium such as diabetes, cardiovascular, cancer etc.
  • Patients on anti-inflammatory, perioceutics, antibiotics, steroids, cytotoxic and drugs since 03 months.
  • Patients who have known allergy to the material used for the study.
  • Pregnant and lactating mothers.
  • Patients had undergone any kind of nonsurgical and/or surgical periodontal therapy earlier, in the past 6 months.
  • Tobacco users (smoke and smokeless) and alcoholics.

结局指标

主要结局

Counting of the colony-forming units (CFU)

时间窗: Up to 48 hr

Preformed 10% blood agar plates were used which were incubated at 37°C for 48 hr after collecting the sample. Counting of the colony-forming units (CFU) was performed by the microbiologist, who was blinded regarding the time of exposure and location of agar plate. The microbial counting was done after that.

次要结局

未报告次要终点

研究者

发起方
Government College of Dentistry, Indore
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Pratik kumar Ashok bhai Chaudhari

Principal Investigator

Government College of Dentistry, Indore

研究点 (2)

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