AzTrials
AzTrials

Mild GingivitisNCT03550651

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

A study testing Licorice, Hypertonic salt solution and Essential oil in people with Mild Gingivitis and Periodontal Diseases, run by Government College of Dentistry, Indore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Mild Gingivitis, Periodontal Diseases, Plaque
What is being tested?
Licorice, Hypertonic salt solution and Essential oil
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
35 participants
Where
No sites listed yet
Study dates
Aug 2016to 10 Jun 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • General/Medical
  • Any race/ethnic group
  • Aged - 18-30 years
  • Male or female
  • No acute or chronic systemic conditions (see exclusion criteria below)
  • No medications/medication history that can interfere with the study (see exclusion criteria below)
Show all 14Show fewer
  • 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
  • <!-- -->
  • 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).

Who cannot join

  • General/Medical A) Any known systemic disease which has effects on periodontium such as diabetes, cardiovascular, cancer etc.
  • Volunteers on anti-inflammatory, antibiotics, steroids, cytotoxic, and perioceutics, since 03 months.
  • 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.
  • Patients with removable or fixed orthodontic appliances

About this study

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"

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.

Read the detailed description

Periodontal disease is a chronic inflammatory process accompanied by destruction of attachment apparatus of tooth and may lead to loss of teeth. It is a multifactorial disease, dental plaque being considered as primary etiologic factor in initiation and progression of disease. Control of periodontal disease by eliminating all pathogenic organisms of the microflora is, as yet, impossible but, it is theoretically an attractive aspect. Based on epidemiological studies there is a very strong correlation between the localization of dentogingival plaque and periodontal disease. Studies have clearly demonstrated that the ability to control the onset or progression of periodontal diseases is improved by regular plaque control practices. Although data shows that oral health can be improved through effective plaque control by mechanical means of cleaning but it fails to deliver optimal levels of oral health because the techniques are not being practiced consistently or thoroughly by all the individuals.

Over the past decade, various antimicrobial compounds have been investigated for their effectiveness to control plaque, but, chlorhexidine digluconate (CHX) is still being considered to be the most effective plaque inhibitor against which other antiplaque agents are measured. Chlorhexidine mouthwash is regarded as Gold standard mouthwash but has many local side effects: extrinsic brown staining of teeth and tongue, taste disturbance, enhanced supragingival calculus formation, desquamation of oral mucosa, and even liver damage in rats.

Cost effectiveness of chlorhexidine also matters especially in underdeveloped and developing countries where prevalence ratio of periodontal diseases are very high. The prevalence of gingivitis and periodontitis, along with their severity and rate of progression is found to vary worldwide; high in developing countries with approximately 80% prevalence in India.

Plant essential oils (EO) have the potential to be used as therapeutic agents for chronic gingivitis and periodontitis conditions that have both bacterial and inflammatory components. These are useful as their long term daily use has no adverse effects on the health of an individual. Also, these are more cost-effective and easily available as over-the-counter products.

It is need of the hour / high time to conduct the research work on various traditional oral hygiene practices / medicines to see their efficacy in the field of periodontics, as various uses of traditional medicine are still untouched \& unexplored and few/no any such scientific documents are available, worldwide. And thus, attempts should be made to search for an alternative; Antiplaque, Plaque inhibitory, Anti gingivitis, Host modulating agent, and any other way acting on various levels of prevention of Gingival / Periodontal diseases by using traditional oral hygiene practices/ indigenous products/ homemade remedies/ medicines for maintenance of oral hygiene. Such research work may not only give an alternate antiplaque / plaque inhibitory, and anti-gingivitis agents but, at the same time may give different avenues in imparting treatment modalities on various levels of prevention of Gingival and Periodontal diseases. They may be more effective, more practical, less time consuming, and within the reach of each \& every individual of the world in comparison to gold standard 'Chlorhexidine Gluconate Mouthrinse' and various other expensive therapeutic procedures.

Glycyrrhiza glabra (Licorice) (Family: Fabaceae) is one of the most important herbs and has been commonly utilised as ayurvedic medicine. It has been described as 'The grandfather of herbs' (Ody, 2000). In almost every Indian household you may find this herb chewed whenever someone's voice goes down. The earliest evidence regarding the use of licorice comes from the samples of licorice found in the tombs of Egyptian pharaohs, including those found in tomb of King Tut (1343 to 1325 BC). The main usage of licorice as a medicinal plant in European culture have been in the treatment of peptic ulcers and bronchial catarrhs. In Chinese herbal medicine, licorice is used as an expectorant, an analgesic, drug to treat asthma, drug to alleviate abscesses and abdominal pain. Licorice, since years is known for its anti-inflammatory, antimicrobial, antiviral, antiprotozoal, antioxidative, hepatoprotective, cardioprotective, immunomodulatory and antitumour activity.

There has been some indications that suggests licorice can be beneficial for oral health. One of the most important research has focussed on the benefits of water extract of licorice root for treatment of apthous ulcers. Glycyrrhizin, the sweet component of licorice root has antiplaque property. Pterocarpenes isolated from G. uralensis root extract exerts an antibacterial activity against Streptococcus mutans. So far, hardly any study has been conducted to see the antiplaque and antigingivitis effect of licorice as a traditional medicinal herb.

Life cannot exist without salt. Salt in various forms is being used since ages. 'Salt water' has been used by many cultures over countless generations to clean wounds and rinse mouths. Use of hot salt water rinsing is in practice to reduce the symptoms of pain in both gums and throat. It is also being routinely recommended following dental extraction, to keep food debris out of healing wounds and to reduce the incidence of alveolar osteitis. 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 but its antiplaque efficacy is yet to be established with stabilised formula.

Above stated background have stimulated and encouraged us to conduct the study so, theinvestigators hypothesized the antiplaque efficacy of Licorice extract mouthrinse (LE) , 5% Hypertonic salt solution (HSS) as mouth rinses. Hence, the investigators planned this study titled "Evaluation of Antiplaque Efficacy of Licorice Extract Mouthrinse \& 5% Hypertonic Salt Solution and their Comparison with Essential Oil \& Chlorhexidine Mouthrinses-An Invitro \& Invivo Study" with aforementioned aims and objectives.

Being tested
Licorice, Hypertonic salt solution, Essential oil, Chlorhexidine Gluconate, Distilled water
Keywords
Plaque, Plaque regrowth, Licorice extract, Mouthrinse, Chlorhexidine mouthrinse, Hypertonic salt solution, Essential oils
Medical subject headings
Periodontal Diseases, Plaque, Amyloid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LicoriceOther

    Also called Glycyrrhiza

    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.

  • Hypertonic salt solutionOther

    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.

  • Essential oilOther

    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.

  • Chlorhexidine GluconateOther

    Also called Chlorhexidine

    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.

  • Distilled waterOther

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

Study groups in NCT03550651
Study groupRoleWhat they receive
Licorice extract mouthrinseExperimental10ml twice a day for 4 Days.
Receives: Other: Licorice
Hypertonic salt solutionExperimental10ml twice a day for 4 Days.
Receives: Other: Hypertonic salt solution
Essential oil mouthrinseActive comparator10ml twice a day for 4 Days.
Receives: Other: Essential oil
Chlorhexidine Gluconate mouthrinseActive comparator10ml twice a day for 4 Days.
Receives: Other: Chlorhexidine Gluconate
Distilled waterPlacebo comparator10ml twice a day for 4 Days.
Receives: Other: Distilled water

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: After 4 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2018
  2. Study startAug 2016
  3. Primary completion15 May 2017
  4. Study completion10 Jun 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Model description
5x5 latin cross over study
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03550651
Sponsor's protocol ID
RGulati
Status last verified
May 2018
First submitted
10 Mar 2018
Last updated
8 Jun 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Licorice, Hypertonic salt solution and Essential oil in people with Mild Gingivitis and Periodontal Diseases, run by Government College of Dentistry, Indore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Modified Plaque Index (time frame: After 4 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2018.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in