OSE as a Pre-procedural Mouth Rinse: A Clinical and Microbiological Study.
Condition: Gingivitis; Periodontitis; Aerosol Disease; Gingival Disease; Periodontal Diseases
MeSH terms: Gingivitis; Periodontitis; Periodontal Diseases; Gingival Diseases
Study type: Interventional

Summary: 
      -  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.
    

Detailed description: 
      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.

      Looking into the above background, The investigators hypothesized the beneficial effects of
      Pre-procedural rinsing with an antimicrobial mouthrinse in reducing the level of viable
      bacteria contained in aerosols generated by ultrasonic scaling. Also, very few studies are
      conducted on herbal products as a pre-procedural mouthrinse therefore, the study should be
      conducted to gain evidence regarding their effectiveness. So, The investigators have planned
      to conduct this study.

      This study has been planned and would be conducted in the Department of Periodontology, Govt.
      College of Dentistry, Indore (M.P.). A minimum of 60 Recruited Outdoor Patients age group of
      18-40 years, who abide by approved protocol guidelines, and are ready to give written
      informed consent are enrolled for the study.
    

Intervention name(s): Group PI; Group OC; Group CHX
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Before rinsing with the mouthrinse, Ultrasonic scaling was done in the 1st and 4th quadrant without any mouth rinse (placebo mouthrinse) and fall out samples were collected in the blood agar plates kept at a distance of 0.5 m and 1 m from the oral cavity.; After ultrasonic scaling of the 1st and 4th quadrant minimum 30min interval maintained. After interval of 30min rinsing the mouth with the either OC/CHX/Placebo (OC= Ocimum sanctum mouthrinse, CHX=Chlorhexidine Gluconate mouthrinse) mouthrinse) done for 60s, Ultrasonic scaling was again done in the 2nd and 3rd quadrant and fall out samples were collected in the newly placed blood agar plates kept at 0.5 m and 1 m away from the patient.; After ultrasonic scaling of the 1st and 4th quadrant minimum 30min interval maintained. After interval of 30min rinsing the mouth with the either OC/CHX/Placebo (OC= Ocimum sanctum mouthrinse, CHX=Chlorhexidine Gluconate mouthrinse) mouthrinse) done for 60s, Ultrasonic scaling was again done in the 2nd and 3rd quadrant and fall out samples were collected in the newly placed blood agar plates kept at 0.5 m and 1 m away from the patient.
Other intervention name(s): mouthrinse followed by Ultrasonic scaling; mouthrinse followed by Ultrasonic scaling; Mouthrinse followed by Ultrasonic scaling
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Ultrasonic scaling was done in the 1st and 4th quadrant without any mouth rinse and fall out samples were collected in the blood agar plates kept at a distance of 0.5 m and 1 m from the oral cavity. After ultrasonic scaling of the 1st and 4th quadrant minimum 30min interval maintained. After interval of 30min rinsing the mouth with the either OC/CHX/Placebo (OC= Ocimum sanctum mouthrinse, CHX=Chlorhexidine Gluconate mouthrinse) mouthrinse) done for 60s, Ultrasonic scaling was again done in the 2nd and 3rd quadrant and fall out samples were collected in the newly placed blood agar plates kept at 0.5 m and 1 m away from the patient. Treatment was carried out by placing 03 sterile agar plates uncovered at pre-designated sites to collect samples of aerosolized bacteria After ultrasonic scaling of the 1st and 4th quadrant and after 2nd and 3rd quadrant.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Gingivitis; Aerosol; Ocimum sanctum; Mouth rinse; SRP; Chlorhexidine mouthrinse; Periodontitis