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Evaluation of Antiplaque Efficacy of Licorice Extract Mouthrinse & HSS and Their Comparison With EO & CHX Mouthrinse

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03550651
Recruitment Status : Completed
First Posted : June 8, 2018
Last Update Posted : June 8, 2018
Information provided by (Responsible Party):
Dr. Ruchi Gulati, Government College of Dentistry, Indore

Brief Summary:
Periodontal disease is a multifactorial disease caused by mainly bacterial, genetic, immunological, and environmental factors. Chronic periodontitis, one of the widely prevalent forms of periodontal disease, is characterized by loss of attachment apparatus of the tooth; it can lead to tooth loss. Many non surgical and surgical approaches have been adapted time and again to prevent, intercept, and to treat the various forms of chronic periodontitis. But, these treatment modalities are not approachable by all individuals, because of the various factors such as: low socioeconomic status, illiteracy, high cost of the treatment, no availability of easy and uncomplicated treatment nearby etc. Considering these factors, there are still a need of preventive, practical, and affordable treatment options specially for the population of underdeveloped and developing countries.

Condition or disease Intervention/treatment Phase
Mild Gingivitis Periodontal Diseases Plaque Other: Licorice Other: Hypertonic salt solution Other: Essential oil Other: Chlorhexidine Gluconate Other: Distilled water Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 5x5 latin cross over study
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Evaluation Of Antiplaque Efficacy Of Licorice Extract Mouthrinse & Hypertonic Salt Solution And Their Comparison With Essential Oil & Chlorhexidine Mouthrinses-An Invitro & Invivo Study"
Actual Study Start Date : August 2016
Actual Primary Completion Date : May 15, 2017
Actual Study Completion Date : June 10, 2017

Arm Intervention/treatment
Experimental: Licorice extract mouthrinse
10ml twice a day for 4 Days.
Other: Licorice
Licorice, since years is known for its anti-inflammatory, antimicrobial, antiviral, antiprotozoal, antioxidative, hepatoprotective, cardioprotective, immunomodulatory and antitumour activity. Licorice can be beneficial for oral health. Glycyrrhizin, the sweet component of licorice root has antiplaque property. Pterocarpenes isolated from G. uralensis root extract exerts an antibacterial activity against Streptococcus mutans.
Other Name: Glycyrrhiza

Experimental: Hypertonic salt solution
10ml twice a day for 4 Days.
Other: Hypertonic salt solution
The antiseptic and bactericidal qualities of salt help in removing plaque which is a cause of gingivitis and caries. Warming water with a pinch of table salt can reduce or even be an alternative to anti-inflammatory drugs intra-orally. Its high osmolality reduces inflammation and can be microbicidal. Moreover, efficacy of luke warm hypertonic salt solution has shown antimicrobial, anti-inflammatory and immunomodulatory properties.

Active Comparator: Essential oil mouthrinse
10ml twice a day for 4 Days.
Other: Essential oil
Essential oils have a wide application in folk medicine, food flavoring and preservation as well as in fragrance industries. The antimicrobial properties of essential oils have been known for many centuries. In recent years, a large number of essential oils and their constituents have been investigated for their antimicrobial properties against some bacteria and fungi. Essential oils have the potential to be used as therapeutic agents for chronic gingivitis and periodontitis conditions that have both bacterial and inflammatory components.

Active Comparator: Chlorhexidine Gluconate mouthrinse
10ml twice a day for 4 Days.
Other: Chlorhexidine Gluconate
Chlorhexidine is a symmetrical bisbiguanide synthetic antiseptic. It is available in three forms, digluconate, acetate and hydrochloride salts. Which have broad spectrum antimicrobial activity; it is effective against both Gram-positive and Gram-negative bacteria including aerobes and anaerobes, yeasts, fungi and lipid enveloped viruses. Chlorhexidine is considered to be the most effective plaque inhibitor against which other antiplaque agents are measured.
Other Name: Chlorhexidine

Placebo Comparator: Distilled water
10ml twice a day for 4 Days.
Other: Distilled water
Distilled water is commonly placebo in various research projects and it is also useful in as placebo treatment.

Primary Outcome Measures :
  1. Modified Plaque Index [ Time Frame: After 4 days ]
    Modified Plaque Index (Turesky, Gilmore, Glickman modification of Quigely Hein Index, 1970) after disclosing the teeth with two tone solution the PI was recorded. Facial and lingual aspects were scored with PI. Scoring was as follows: 0 - No plaque/debris 1 - Separate flecks of plaque at the cervical margin of the tooth. 2 - A thin continuous band of plaque (up to 1mm) at the cervical margin of the tooth. 3 - A band of plaque wider than 1 mm but covering less than one third of the crown of the tooth 4 - plaque covering at least one third but less than two thirds of the crown of the tooth. 5 - Plaque covering two third or more of the crown of the tooth. Modified Plaque Index = Total score / no. of surfaces examined.

Other Outcome Measures:
  1. Minimum inhibitory concentration [ Time Frame: 72 hours ]
    Minimum inhibitory concentration (MIC) is the lowest concentration of an antimicrobial (like an antifungal, antibiotic or bacteriostatic) drug that will inhibit the visible growth of a microorganism after overnight incubation). Tested against following periopathogens: Porphyromona sgingivalis, Prevotella intermedia, fusobacteriumnucleatum, Aggregatibacter actinomycetemcomitans, Capnocytophaga, Tannerella forsythia, Pseudomonas aeruginosa, Streptococcus mutans, E. faecalis, and Candida.

  2. Minimum bactericidal concentration [ Time Frame: 72 hours ]
    Minimum bactericidal concentration (MBC) is the lowest concentration of an antibacterial agent required to kill a particular bacterium. It can be determined from broth dilution minimum inhibitory concentration (MIC) tests by sub culturing to agar plates that do not contain the test agent. Tested against following periopathogens: Porphyromonas gingivalis, Prevotella intermedia, fusobacterium nucleatum, Aggregatibacter actinomycetemcomitans, Capnocytophaga, Tannerella forsythia, Pseudomonas aeruginosa, Streptococcus mutans, E. faecalis, and Candida.

Information from the National Library of Medicine

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

Inclusion Criteria:

  • General/Medical

    1. Any race/ethnic group
    2. Aged - 18-30 years
    3. Male or female
    4. No acute or chronic systemic conditions (see exclusion criteria below)
    5. No medications/medication history that can interfere with the study (see exclusion criteria below)
    6. Non-smoker, Non-alcoholic
    7. Who was ready to comply with study procedures
    8. Who was available for the duration of the study
    9. Who were ready to provide signed informed consent Oral/Periodontal
    1. Dentate with at least 14 natural teeth, excluding third molars, that can be evaluated periodontally.
    2. Patients with Healthy periodontium and/or Mild Gingivitis.
    3. No acute oral diseases (mucosal lesions), oral infections, need for immediate dental/periodontal care (e.g., NUG).

Exclusion Criteria:

  • General/Medical A) Any known systemic disease which has effects on periodontium such as diabetes, cardiovascular, cancer etc.

B) Volunteers on anti-inflammatory, antibiotics, steroids, cytotoxic, and perioceutics, since 03 months.

C) Volunteers who are known allergic to any substance. D) Pregnant and lactating mothers. E) Volunteers who had dental caries. F) Tobacco users (smoke and smokeless) and Alcoholics. G) Volunteers wearing any form of intraoral prosthesis or appliance. Oral/Periodontal

  1. <14 teeth that can be periodontally evaluated (excluding 3rd molars)
  2. Dental volunteers with compromised periodontal status/ any sign of moderate or severe gingivitis and periodontitis.
  3. Acute oral infections.
  4. Oral wounds, including recent extractions.
  5. Patients with removable or fixed orthodontic appliances

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 identifier (NCT number): NCT03550651

Sponsors and Collaborators
Government College of Dentistry, Indore
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Study Chair: Dr Subhash Garg Govt. College of Dentistry Indore, M.P. India,Indore, M.P, India, 452001

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Responsible Party: Dr. Ruchi Gulati, Post Graduate Student, Government College of Dentistry, Indore Identifier: NCT03550651     History of Changes
Other Study ID Numbers: RGulati
First Posted: June 8, 2018    Key Record Dates
Last Update Posted: June 8, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Dr. Ruchi Gulati, Government College of Dentistry, Indore:
Plaque regrowth
Licorice extract
Chlorhexidine mouthrinse
Hypertonic salt solution
Essential oils
Additional relevant MeSH terms:
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Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Gingival Diseases
Chlorhexidine gluconate
Pharmaceutical Solutions
Anti-Infective Agents, Local
Anti-Infective Agents
Dermatologic Agents