<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03839719</url>
  </required_header>
  <id_info>
    <org_study_id>052/IEC/SS/2019</org_study_id>
    <nct_id>NCT03839719</nct_id>
  </id_info>
  <brief_title>OSE as a Pre-procedural Mouth Rinse: A Clinical and Microbiological Study.</brief_title>
  <official_title>Efficacy of Ocimum Sanctum as a Pre-procedural Mouth Rinse in Reducing Aerosol Contamination Produced by Ultrasonic Scaler: a Clinical and Microbiological Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Government College of Dentistry, Indore</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Government College of Dentistry, Indore</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      -  Periodontal disease- Inflammatory, Multifactorial, and Threshold disease. Periodontal&#xD;
           disease is a highly prevalent dental disease, an almost 100% prevalence in developing&#xD;
           countries.&#xD;
&#xD;
        -  Non-surgical periodontal includes scaling and root planing (SRP) an essential part of&#xD;
           successful periodontal therapy.&#xD;
&#xD;
        -  The spread of infection through aerosol and splatter has long been considered one of the&#xD;
           main reason for the possible transmission of infectious agents and their ill effects on&#xD;
           The Health of patients and Dental Health care Professionals.&#xD;
&#xD;
        -  Aerosols are generated during Tooth preparation/Rotary instrument/ air&#xD;
           abrasion/Air-water syringe, Ultrasonic scaler, and while doing Air polishing.&#xD;
&#xD;
        -  Studies have also reported an association of these aerosols with Respiratory infections,&#xD;
           Ophthalmic and Skin infections, Tuberculosis, and Hepatitis B. current research suggests&#xD;
           that having patients use an antimicrobial rinse before treatment may decrease microbial&#xD;
           aerosols.&#xD;
&#xD;
        -  Chlorhexidine mouthwash is regarded as Gold Standard mouthwash but, have many local side&#xD;
           effects including have many local side effects including extrinsic tooth and tongue&#xD;
           brown staining, taste disturbance, enhanced supragingival calculus formation, less&#xD;
           commonly, desquamation of oral mucosa, and even liver damage in rats.&#xD;
&#xD;
        -  In the emerging era of pharmaceuticals, herbal medicines with their naturally occurring&#xD;
           active ingredients offer a gentle and enduring way for the restoration of health by the&#xD;
           least harmful method.&#xD;
&#xD;
        -  Ocimum Sanctum (Tulsi) is known as THE QUEEN OF HERBS effective in reducing plaque&#xD;
           accumulation, gingival inflammation, and bleeding &amp; has no side effects as compared to&#xD;
           Chlorhexidine. Very few studies which can be counted on fingers have been conducted&#xD;
           worldwide in this direction, globally showing their beneficial effects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The spread of infection through aerosol and splatter has long been considered one of the main&#xD;
      reason for the possible transmission of infectious agents and their ill effects on the health&#xD;
      of patients and dental health care professionals. Aerosol and splatter are a concern in&#xD;
      dentistry because of their potential effects on the health of immuno-compromised patients and&#xD;
      of dental personnel. These aerosols may be inhaled into the lungs to reach the alveoli or may&#xD;
      come in contact with the skin or mucous membranes. Most of the aerosols produced during&#xD;
      treatment procedures have a diameter of 5μm or less, and these can cause respiratory or other&#xD;
      health problems because they can penetrate into, and remain within the lungs. The oral cavity&#xD;
      consists of billions and billions of microorganisms, which can get transmitted from one&#xD;
      person to another through water contamination, surface contact or through aerosols. Aerosols&#xD;
      are generated during tooth preparation with a rotary instrument or air abrasion, during the&#xD;
      use of an air-water syringe, ultrasonic scaler, and while doing air polishing. Miller (1976)&#xD;
      found that aerosols generated from patients' mouths contained up to a million bacteria per&#xD;
      cubic foot of air.&#xD;
&#xD;
      All health care professionals including the dentists, dental hygienists, and nurses can get&#xD;
      exposed to microorganisms present in patients' blood, saliva and from instruments, which can&#xD;
      lead to cross infections. The oral cavity harbors numerous bacteria and viruses from the&#xD;
      respiratory tract, dental plaque, and oral fluids. Viruses which are present in aerosols such&#xD;
      as human immunodeficiency virus hepatitis B can penetrate the conjunctiva, respiratory tract&#xD;
      of clinician, assistant, and patients. In addition to this, some viruses such as mumps,&#xD;
      rubella, and influenza also pose a serious risk to health care professionals. Any dental&#xD;
      procedure that has the potential to aerosolize saliva will cause contamination of air with&#xD;
      organisms from some or all of these sources. Other studies have also reported an association&#xD;
      of these aerosols with respiratory infections, ophthalmic and skin infections, tuberculosis,&#xD;
      and hepatitis B. Current research suggests that having patients use an antimicrobial rinse&#xD;
      before treatment may decrease microbial aerosols.&#xD;
&#xD;
      Chlorhexidine gluconate, a bisbiguanide, is considered to be the gold standard of&#xD;
      antimicrobial rinses because of broad-spectrum antibacterial activity but, it also has some&#xD;
      side effects, notably tooth staining, taste alteration, enhanced supragingival calculus&#xD;
      formation and less commonly desquamation of the oral mucosa. Also other then Chlorhexidine&#xD;
      Providone iodine and essential oils are commonly used as mouthrinse.&#xD;
&#xD;
      In the emerging era of pharmaceuticals, herbal medicines with their naturally occurring&#xD;
      active ingredients offer a gentle and enduring way for the restoration of health by the least&#xD;
      harmful method. Herbal medicine is both promotive and preventive in its approach. Also,&#xD;
      herbal mouth rinses with their natural ingredients offer a safe and effective option as&#xD;
      mouthrinse.&#xD;
&#xD;
      The herbal mouthwash used in this study is made from natural herb extracts of Ocimum sanctum.&#xD;
      Ocimum sanctum is commonly known as 'Tulsi' and popularly known as 'The Queen of Herbs', and&#xD;
      the &quot;Mother Medicine of Nature&quot; due to its perceived medicinal qualities. Tulsi extract has&#xD;
      been widely used in traditional medicine and human clinical trial without significant side&#xD;
      effects. Scientific investigations during the last several decades have shown that various&#xD;
      parts of Ocimum sanctum, including leaves, stem, root, flowers, and seed, have a plethora of&#xD;
      biological and pharmacological activities, including antioxidant, anti-inflammatory,&#xD;
      antiallergic, immunomodulatory, antimicrobial etc.&#xD;
&#xD;
      Looking into the above background, The investigators hypothesized the beneficial effects of&#xD;
      Pre-procedural rinsing with an antimicrobial mouthrinse in reducing the level of viable&#xD;
      bacteria contained in aerosols generated by ultrasonic scaling. Also, very few studies are&#xD;
      conducted on herbal products as a pre-procedural mouthrinse therefore, the study should be&#xD;
      conducted to gain evidence regarding their effectiveness. So, The investigators have planned&#xD;
      to conduct this study.&#xD;
&#xD;
      This study has been planned and would be conducted in the Department of Periodontology, Govt.&#xD;
      College of Dentistry, Indore (M.P.). A minimum of 60 Recruited Outdoor Patients age group of&#xD;
      18-40 years, who abide by approved protocol guidelines, and are ready to give written&#xD;
      informed consent are enrolled for the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 9, 2019</start_date>
  <completion_date type="Actual">May 25, 2019</completion_date>
  <primary_completion_date type="Actual">April 26, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <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.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    <masking_description>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.&#xD;
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</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Counting of the colony-forming units (CFU)</measure>
    <time_frame>Up to 48 hr</time_frame>
    <description>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.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Gingivitis</condition>
  <condition>Periodontitis</condition>
  <condition>Aerosol Disease</condition>
  <condition>Gingival Disease</condition>
  <condition>Periodontal Diseases</condition>
  <arm_group>
    <arm_group_label>Group OC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ocimum sanctum (OC) is a natural herb which is known for its broad spectrum medicinal properties. Ocimum sanctum is also listed by the U.S. FDA as an herb Generally Recognized As Safe (GRAS) for its intended use as a therapeutic herb. Pharmacological constitutes present in the extract are eugenol, Urosolic acid, Carvacrol, linalool , limatrol, caryophyllene, and methyl carvicol. The literature showed that Ocimum sanctum extract has significant anti-gingivitis and anti-inflammatory effect as mouthrinse.&#xD;
Other Names:&#xD;
Tulsi Holy Basil</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group CHX</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Chlorhexidine Gluconate (C34H54Cl2N10O14) is a bisbiguanide formulation with cationic properties. A literature review, highlighting chlorhexidine as not only a plaque control agent but also as an effective antimicrobial agent and its wider application in a variety of oral disorders in various formulations.&#xD;
As an antimicrobial agent, chlorhexidine is effective in vitro against both Gram-positive and Gram-negative bacteria including aerobes and anaerobes and yeasts and fungi. The digluconate of chlorhexidine (1:6Di 4' chlorophenyl-diguani-dohexane) is a synthetic antimicrobial drug which has been widely used as a broad spectrum antiseptic.&#xD;
Other Names:&#xD;
Chlorhexidine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group PI</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Group PI: Placebo (Distilled water) as the mouthrinse.&#xD;
Placebo (Distilled water) 10 ml is used as mouthrinse. Distilled water is commonly used as an excipient in a variety of drugs and it is also widely used as a placebo.&#xD;
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.&#xD;
Treatment was carried out by placing 03 sterile agar plates uncovered at pre-designated sites to collect samples of aerosolized bacteria.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Group PI</intervention_name>
    <description>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.</description>
    <arm_group_label>Group PI</arm_group_label>
    <other_name>mouthrinse followed by Ultrasonic scaling</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Group OC</intervention_name>
    <description>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.</description>
    <arm_group_label>Group CHX</arm_group_label>
    <arm_group_label>Group OC</arm_group_label>
    <other_name>mouthrinse followed by Ultrasonic scaling</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Group CHX</intervention_name>
    <description>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.</description>
    <arm_group_label>Group CHX</arm_group_label>
    <arm_group_label>Group OC</arm_group_label>
    <other_name>Mouthrinse followed by Ultrasonic scaling</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Cases with Generalized Chronic Gingivitis or cases with mild&#xD;
&#xD;
          2. Generalized Chronic Periodontitis patients of any sex.&#xD;
&#xD;
          3. Systemically healthy individuals.&#xD;
&#xD;
          4. Patient having ≥ 20 teeth.&#xD;
&#xD;
          5. Patients in the age group of 18-40 years, who abide by approved protocol guidelines,&#xD;
             and are ready to give written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any known systemic disease which has effects on periodontium such as diabetes,&#xD;
             cardiovascular, cancer etc.&#xD;
&#xD;
          2. Patients on anti-inflammatory, perioceutics, antibiotics, steroids, cytotoxic and&#xD;
             drugs since 03 months.&#xD;
&#xD;
          3. Patients who have known allergy to the material used for the study.&#xD;
&#xD;
          4. Pregnant and lactating mothers.&#xD;
&#xD;
          5. Patients had undergone any kind of nonsurgical and/or surgical periodontal therapy&#xD;
             earlier, in the past 6 months.&#xD;
&#xD;
          6. Tobacco users (smoke and smokeless) and alcoholics.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>DR.MADHU S. RATRE, M.D.S.</last_name>
    <role>Study Director</role>
    <affiliation>Govt. college of dentistry, Indore</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of periodontology, GDC Indore</name>
      <address>
        <city>Indore</city>
        <state>Madhu Pradesh</state>
        <zip>452001</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/23855840</url>
    <description>Efficacy of preprocedural mouth rinsing in reducing aerosol contamination produced by ultrasonic scaler: a pilot study.</description>
  </link>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/23055587</url>
    <description>Efficacy of 0.2% tempered chlorhexidine as a pre-procedural mouth rinse: A clinical study.</description>
  </link>
  <results_reference>
    <citation>Gupta G, Mitra D, Ashok KP, Gupta A, Soni S, Ahmed S, Arya A. Efficacy of preprocedural mouth rinsing in reducing aerosol contamination produced by ultrasonic scaler: a pilot study. J Periodontol. 2014 Apr;85(4):562-8. doi: 10.1902/jop.2013.120616. Epub 2013 Jul 15.</citation>
    <PMID>23855840</PMID>
  </results_reference>
  <results_reference>
    <citation>Reddy S, Prasad MG, Kaul S, Satish K, Kakarala S, Bhowmik N. Efficacy of 0.2% tempered chlorhexidine as a pre-procedural mouth rinse: A clinical study. J Indian Soc Periodontol. 2012 Apr;16(2):213-7. doi: 10.4103/0972-124X.99264.</citation>
    <PMID>23055587</PMID>
  </results_reference>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>February 1, 2019</study_first_submitted>
  <study_first_submitted_qc>February 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>June 25, 2019</last_update_submitted>
  <last_update_submitted_qc>June 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 26, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Government College of Dentistry, Indore</investigator_affiliation>
    <investigator_full_name>Dr. Pratik kumar Ashok bhai Chaudhari</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Gingivitis</keyword>
  <keyword>Aerosol</keyword>
  <keyword>Ocimum sanctum</keyword>
  <keyword>Mouth rinse</keyword>
  <keyword>SRP</keyword>
  <keyword>Chlorhexidine mouthrinse</keyword>
  <keyword>Periodontitis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gingivitis</mesh_term>
    <mesh_term>Periodontitis</mesh_term>
    <mesh_term>Periodontal Diseases</mesh_term>
    <mesh_term>Gingival Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03839719
org study id: 052/IEC/SS/2019
nct id: NCT03839719
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
-  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.
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.
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.
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
masking description: 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
measure: Counting of the colony-forming units (CFU)
time frame: Up to 48 hr
description: 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.
arm group label: Group OC
arm group type: Experimental
description: Ocimum sanctum (OC) is a natural herb which is known for its broad spectrum medicinal properties. Ocimum sanctum is also listed by the U.S. FDA as an herb Generally Recognized As Safe (GRAS) for its intended use as a therapeutic herb. Pharmacological constitutes present in the extract are eugenol, Urosolic acid, Carvacrol, linalool , limatrol, caryophyllene, and methyl carvicol. The literature showed that Ocimum sanctum extract has significant anti-gingivitis and anti-inflammatory effect as mouthrinse.
Other Names:
Tulsi Holy Basil
arm group label: Group CHX
arm group type: Active Comparator
description: Chlorhexidine Gluconate (C34H54Cl2N10O14) is a bisbiguanide formulation with cationic properties. A literature review, highlighting chlorhexidine as not only a plaque control agent but also as an effective antimicrobial agent and its wider application in a variety of oral disorders in various formulations.
As an antimicrobial agent, chlorhexidine is effective in vitro against both Gram-positive and Gram-negative bacteria including aerobes and anaerobes and yeasts and fungi. The digluconate of chlorhexidine (1:6Di 4' chlorophenyl-diguani-dohexane) is a synthetic antimicrobial drug which has been widely used as a broad spectrum antiseptic.
Other Names:
Chlorhexidine
arm group label: Group PI
arm group type: Placebo Comparator
description: Group PI: Placebo (Distilled water) as the mouthrinse.
Placebo (Distilled water) 10 ml is used as mouthrinse. Distilled water is commonly used as an excipient in a variety of drugs and it is also widely used as a placebo.
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.
Treatment was carried out by placing 03 sterile agar plates uncovered at pre-designated sites to collect samples of aerosolized bacteria.
intervention type: Procedure
intervention name: Group PI
description: 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.
arm group label: Group PI
other name: mouthrinse followed by Ultrasonic scaling
intervention type: Procedure
intervention name: Group OC
description: 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.
arm group label: Group CHX
arm group label: Group OC
other name: mouthrinse followed by Ultrasonic scaling
intervention type: Procedure
intervention name: Group CHX
description: 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.
arm group label: Group CHX
arm group label: Group OC
other name: Mouthrinse followed by Ultrasonic scaling
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: DR.MADHU S. RATRE, M.D.S.
role: Study Director
affiliation: Govt. college of dentistry, Indore
facility: 
country: India
url: https://www.ncbi.nlm.nih.gov/pubmed/23855840
description: Efficacy of preprocedural mouth rinsing in reducing aerosol contamination produced by ultrasonic scaler: a pilot study.
url: https://www.ncbi.nlm.nih.gov/pubmed/23055587
description: Efficacy of 0.2% tempered chlorhexidine as a pre-procedural mouth rinse: A clinical study.
citation: Gupta G, Mitra D, Ashok KP, Gupta A, Soni S, Ahmed S, Arya A. Efficacy of preprocedural mouth rinsing in reducing aerosol contamination produced by ultrasonic scaler: a pilot study. J Periodontol. 2014 Apr;85(4):562-8. doi: 10.1902/jop.2013.120616. Epub 2013 Jul 15.
PMID: 23855840
citation: Reddy S, Prasad MG, Kaul S, Satish K, Kakarala S, Bhowmik N. Efficacy of 0.2% tempered chlorhexidine as a pre-procedural mouth rinse: A clinical study. J Indian Soc Periodontol. 2012 Apr;16(2):213-7. doi: 10.4103/0972-124X.99264.
PMID: 23055587
responsible party type: Principal Investigator
investigator affiliation: Government College of Dentistry, Indore
investigator full name: Dr. Pratik kumar Ashok bhai Chaudhari
investigator title: Principal Investigator
mesh term: Gingivitis
mesh term: Periodontitis
mesh term: Periodontal Diseases
mesh term: Gingival Diseases
sharing ipd: Undecided