Comparative Evaluation of Antiplaque and Antigingivitis Efficacy of Ocimum Sanctum (Tulsi) Extract
Condition: Periodontal Diseases; Gingivitis; Periodontitis
MeSH terms: Gingivitis; Periodontitis; Periodontal Diseases
Study type: Interventional

Summary: 
      Chlorhexidine is considered as gold standard for its antiplaque and antigingivitis efficacy
      till date but it has got many side effects. So it is need of the hour that investigators will
      find some substitute having similar antiplque and antigingivitis efficay but have less or no
      adverse effects. so in this study investigators planned to do "Comparative evaluation of
      antiplaque and antigingivitis efficacy of ocimum sanctum (tulsi) extract mouthrinse with
      0.12% chlorhexidine mouthrinse.
    

Detailed description: 
      Title:

      "Comparative evaluation of antiplaque and antigingivitis efficacy of ocimum sanctum (tulsi)
      extract mouthrinse with 0.12% chlorhexidine mouthrinse - an in vitro and in vivo study."

      Aims And Objectives:

        1. To evaluate the antimicrobial activity of Ocimum sanctum (Tulsi) extract by Sensitivity
           testing, Minimum Inhibitory Concentration, Minimum Bactericidal Concentration, and Time
           kill curve -In Vitro study.

        2. To evaluate the Antiplaque and Antigingivitis effect of the Ocimum sanctum (Tulsi) by
           recording Modified Gingival Index and Modified Plaque Index in patients with Chronic
           Generalized Gingivitis and Mild Chronic Generalized Periodontitis -In Vivo study.

        3. Clinical evaluation and comparison of the Antiplaque and Antigingivitis effect of the
           Ocimum sanctum (Tulsi) with 0.12% Chlorhexidine and vehicle.

        4. To see the topical beneficial and/or harmful side effects of Ocimum sanctum extract, if
           any.

      Study Design:

      Prospective randomized controlled Trial- Randomized Comparative Study

      Methodology (Material & Methods):

      The present study will have following parts:

        1. Procurement of extract and formulation of mouthrinse: Ocimum sanctum (Tulsi) extract has
           been purchased from the ISO (International Organization for Standardization) Certified
           shop. The desired mouthrinse will be formulated under the guidance of Department of
           Pharmacology, Mahatma Gandhi Memorial Medical College, Indore (M.P.)

        2. In vitro study: Sensitivity testing, Minimum Inhibitory Concentration (MIC) and Minimum
           Bactericidal Concentration (MBC), of Ocimum sanctum will be determined against following
           microorganisms: Porphyromonas gingivalis, Prevotella intermedia, Fusobacterium
           nucleatum, Aggregatibacter actinomycetemcomitans, Capnocytophaga, Tannerella forsythia,
           Pseudomonas aeruginosa, and other microorganisms.

        3. In vivo study: This study has been planned and would be conducted in the Department of
           Periodontology, Govt. College of Dentistry, Indore, Madhya pradesh, India. In this
           study, participants with Chronic Generalized Gingivitis and Mild Chronic Generalized
           Periodontitis would be randomly selected from outdoor patients. A minimum 90 Recruited
           participants will be divided into three equal groups randomly. (Parallel design, case
           control, Randomized Comparative Study).

      Group A: (Test group) (n=30) Ocimum sanctum extract as mouthrinse. Group B: (Positive control
      group) (n=30) 0.12% Chlorhexidine as mouthrinse. Group C: (control group) (n=30) Vehicle as
      the mouthrinse. All the three solutions would be prepared under the valuable guidance of
      Department of Pharmacology, Mahatma Gandhi Memorial Medical College, Indore (M.P.) and will
      be kept in coded containers. All the participants in each group would be advised to use their
      respective mouth rinses twice daily with proper swishing action for a minute, after brushing
      their teeth (in the morning and before going to bed). To maintain standardization, similar
      toothbrushes and dentifrices will be provided to all the participants (free of cost) and
      standard tooth brushing techniques will be demonstrated.

      Written consent will be obtained from each participants, and then followed by case history
      taking along with clinical examination by recording various periodontal parameters taken in
      the study.

      Following clinical periodontal parameters are to be recorded at baseline, at 1 week, at 2
      weeks, and at 3 weeks:

        1. Modified Gingival Index

        2. Modified Plaque Index

      Sample Size:

      Minimum 90 patients with Generalized Chronic Gingivitis or Mild Generalized Chronic
      Periodontitis will be selected. Participants will be divided into 03 different groups, n=30
      participants in each group by computer generated table of random numbers.

      Data Collection And Methods:

      Cases with Generalized Chronic Gingivitis or Mild Generalized Chronic Periodontitis of either
      sex and the age group 18-40 years who abide by approved protocol guidelines and are ready to
      give written informed consent will be selected randomly from OPD (outpatient department) of
      The Department of Periodontology, Govt. College of Dentistry, Indore (M.P.). The selected
      participants will be equally divided into three groups, by computer generated random number
      table.
    

Intervention name(s): Ocimum sanctum; Chlorhexidine Gluconate; Propylene Glycol
Intervention type(s): Other; Other; Other
Intervention description(s): Ocimum sanctum (known as Tulsi, Holy basil) is natural herb which is known for its broad spectrum medicinal properties. Ocimum sanctum is one of the best examples of Ayurveda's holistic lifestyle approach to health. It is also been well practiced in traditional medicine in India and south Asian region. Literature showed that Ocimum sanctum extract have significant anti-gingivitis and anti-inflammatory effect as mouthrinse.; Chlorhexidine Gluconate (C34H54Cl2N10O14) is a bisbiguanide formulation with cationic properties. Chlorhexidine over a period of over 40 years has been thoroughly investigated and successfully used as plaque control agent in dental practice. A literature review, highlighting chlorhexidine as not only a plaque control agent but also as an effective antimicrobial agent and its wider application in variety of oral disorders in various formulations.; Propylene glycol or 1,2-dihydroxypropane or 1,2-propanediol, is a clear, colourless, viscous, practically odourless liquid with a density of 1.038 g/cm³ at 20 °C and a molecular weight of 76.095. It is miscible with water, acetone and chloroform. It is miscible in water. Propylene glycol is commonly used as an excipient in a variety of drugs and it is also authorised in food products and cosmetics.
Other intervention name(s): Tulsi; Holy Basil; Chlorhexidine
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Mouthrinse; Ocimum sanctum; Periodontal Diseases; Tulsi