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

NCT03550651 | Completed DMC

• 1 other identifier: RGulati
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Mild Gingivitis; Periodontal Diseases; Plaque

Keywords

Plaque; Plaque regrowth; Licorice extract; Mouthrinse; Chlorhexidine mouthrinse; Hypertonic salt solution; Essential oils

Outcome Measures

Primary Outcomes (1)

• Modified Plaque Index

  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.

  After 4 days

Other Outcomes (2)

• Minimum inhibitory concentration

  72 hours

• Minimum bactericidal concentration

  72 hours

Study Arms (5)

Licorice extract mouthrinse

EXPERIMENTAL

10ml twice a day for 4 Days.

Other: Licorice

Hypertonic salt solution

EXPERIMENTAL

10ml twice a day for 4 Days.

Other: Hypertonic salt solution

Essential oil mouthrinse

ACTIVE COMPARATOR

10ml twice a day for 4 Days.

Other: Essential oil

Chlorhexidine Gluconate mouthrinse

ACTIVE COMPARATOR

10ml twice a day for 4 Days.

Other: Chlorhexidine Gluconate

Distilled water

PLACEBO COMPARATOR

10ml twice a day for 4 Days.

Other: Distilled water

Interventions

Licorice OTHER

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.

Also known as: Glycyrrhiza

Licorice extract mouthrinse

Hypertonic salt solution OTHER

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.

Hypertonic salt solution

Essential oil OTHER

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.

Essential oil mouthrinse

Chlorhexidine Gluconate OTHER

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.

Also known as: Chlorhexidine

Chlorhexidine Gluconate mouthrinse

Distilled water OTHER

Distilled water is commonly placebo in various research projects and it is also useful in as placebo treatment.

Distilled water

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• General/Medical
• Any race/ethnic group
• Aged - 18-30 years
• Male or female

You may not qualify if:

• Non-smoker, Non-alcoholic
• Who was ready to comply with study procedures
• Who was available for the duration of the study
• Who were ready to provide signed informed consent Oral/Periodontal
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• Dentate with at least 14 natural teeth, excluding third molars, that can be evaluated periodontally.
• Patients with Healthy periodontium and/or Mild Gingivitis.
• No acute oral diseases (mucosal lesions), oral infections, need for immediate dental/periodontal care (e.g., NUG).
• 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
• \<14 teeth that can be periodontally evaluated (excluding 3rd molars)
• Dental volunteers with compromised periodontal status/ any sign of moderate or severe gingivitis and periodontitis.
• Acute oral infections.
• Oral wounds, including recent extractions.

Sponsors & Collaborators

• Government College of Dentistry, Indore: lead

MeSH Terms

Conditions

Periodontal Diseases; Plaque, Amyloid

Interventions

Glycyrrhiza glabra extract; Oils, Volatile; chlorhexidine gluconate; Chlorhexidine

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Oils; Lipids; Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Dr Subhash Garg

  Govt. College of Dentistry Indore, M.P. India,Indore, M.P, India, 452001

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post Graduate Student

Model Details: 5x5 latin cross over study

Study Record Dates

• First Submitted: March 10, 2018
• First Posted: June 8, 2018
• Study Start: August 1, 2016
• Primary Completion: May 15, 2017
• Study Completion: June 10, 2017
• Last Updated: June 8, 2018

Record last verified: 2018-05