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OSE as a Pre-procedural Mouth Rinse: A Clinical and Microbiological Study.

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ClinicalTrials.gov Identifier: NCT03839719
Recruitment Status : Recruiting
First Posted : February 15, 2019
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Pratik kumar Ashok bhai Chaudhari, Government College of Dentistry, Indore

Brief 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.

Condition or disease Intervention/treatment Phase
Gingivitis Periodontitis Aerosol Disease Gingival Disease Periodontal Diseases Procedure: Group PI Procedure: Group OC Procedure: Group CHX Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
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: Double (Participant, Investigator)
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

Primary Purpose: Treatment
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.
Actual Study Start Date : January 9, 2019
Estimated Primary Completion Date : February 28, 2019
Estimated Study Completion Date : March 15, 2019

Arm Intervention/treatment
Experimental: Group OC

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

Procedure: Group OC
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 Name: mouthrinse followed by Ultrasonic scaling

Procedure: Group CHX
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 Name: Mouthrinse followed by Ultrasonic scaling

Active Comparator: Group CHX

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

Procedure: Group OC
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 Name: mouthrinse followed by Ultrasonic scaling

Procedure: Group CHX
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 Name: Mouthrinse followed by Ultrasonic scaling

Placebo Comparator: Group PI

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.

Procedure: Group PI
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.
Other Name: mouthrinse followed by Ultrasonic scaling




Primary Outcome Measures :
  1. Counting of the colony-forming units (CFU) [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03839719


Contacts
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Contact: Dr.Pratik kumar A. Chaudhari, M.D.S. 9913861326 pratik789.pc@gmail.com
Contact: DR.MADHU S. RATRE, M.D.S. 9406928976 smadhu16feb@yahoo.co.in

Locations
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India
Department of periodontology, GDC Indore Recruiting
Indore, Madhu Pradesh, India, 452001
Contact: Pratik kumar A. Chaudhari, M.D.S.    9913861326    pratik789.pc@gmail.com   
Contact: DR.MADHU S. RATRE, M.D.S.    9406928976    smadhu16feb@yahoo.co.in   
Sponsors and Collaborators
Government College of Dentistry, Indore
Investigators
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Study Director: DR.MADHU S. RATRE, M.D.S. Govt. college of dentistry, Indore

Additional Information:
Publications of Results:
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Responsible Party: Dr. Pratik kumar Ashok bhai Chaudhari, Principal Investigator, Government College of Dentistry, Indore
ClinicalTrials.gov Identifier: NCT03839719     History of Changes
Other Study ID Numbers: 052/IEC/SS/2019
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Dr. Pratik kumar Ashok bhai Chaudhari, Government College of Dentistry, Indore:
Gingivitis
Aerosol
Ocimum sanctum
Mouth rinse
SRP
Chlorhexidine mouthrinse
Periodontitis

Additional relevant MeSH terms:
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Mouth Diseases
Periodontitis
Periodontal Diseases
Gingivitis
Gingival Diseases
Stomatognathic Diseases
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents