Effects of Cardamom and Fennel on Salivary pH and Anti Microbial Activity

NCT05245019 | Completed DMC

• 1 other identifier: AIDM
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Dental caries is the most prevalent infectious disease related to oral health.. Although significant advances have been made on a global front to prevent caries, studies show its incidence is on the rise making it one of the major chronic diseases affecting all age groups. It possesses not only a great load concerning cost on developed nations but an increasing burden on developing nations. It largely affects children and the lower socioeconomic group hence demanding feasible and inexpensive ways to counter this growing ailment. Dental caries is a multifactorial disease involving the interaction of the host, agent, and the environment. The primary etiologic agent implicated in dental caries is the streptococcus mutans and non-streptococcus species like Lactobacillus, Actinomyces, and Veillonella species. These oral microbes break down carbohydrates content in the diet, producing acids as by-products. The acids produced lower the pH of plaque and saliva resulting in the demineralization of enamel and dentine, finally enhancing the formation of cavities or dental caries. The role of saliva in maintaining oral health has been studied extensively over time. The buffering capacity of saliva prevents the teeth from demineralization by maintaining the pH of the oral cavity thereby reducing the risk of dental caries. Since ancient times, medicinal plants and herbs have been used for maintaining oral health. Recent studies have shown fennel seeds and cardamom to play a significant role in regulating the pH of saliva and plaque, and ultimately preventing dental caries. Cardamom (Elettaria cardamomum) is used as a flavoring agent in foods as well as for treating various cardiovascular, gastrointestinal, and neural problems. In addition, its extracts have shown antimicrobial activity against the principal pathogens causing dental caries and oral candidiasis. The commonest are S. mutans and Lactobacillus. Fennel (Foeniculum vulgare) is a dry seed used in treating various ailments. Known for its anti-inflammatory, anti-spasmodic, and analgesic properties, it is also widely used for treating gastroenteritis and indigestion. Over time, it has been used in many oral care products for its antiseptic properties and as a breath freshener on its own. Studies have found fennel to not only inhibit the activity of streptococcus Mutans but also cause a significant rise in salivary pH hence depicting the anti-cariogenic activity. Given the above literature, this study has been designed to record the effects of cardamom and fennel on the salivary pH and their anti-microbial activity on selected microbial species in our population.

Conditions

Electrolyte Disturbance; Saliva Altered

Outcome Measures

Primary Outcomes (1)

• salivary pH

  Change in pH will be observed before and after cardamom and fennel chewing

  1 Month

Secondary Outcomes (1)

• anti-microbial activity

  1 Month

Study Arms (2)

cardamom group

EXPERIMENTAL

the pH of saliva will be checked first then they r required to chew cardamom nd after 15 minutes again pH will be checked

Biological: cardamom

fennel group

EXPERIMENTAL

the pH of saliva will be checked first then they r required to chew fennel and after 15 minutes again pH will be checked

Biological: fennel

Interventions

cardamom BIOLOGICAL

cardamom is used as a flavoring agent in foods as well as for treating various cardiovascular, gastrointestinal, and neural problems

Also known as: Elettaria cardamomum

cardamom group

fennel BIOLOGICAL

fennel is Known for its anti-inflammatory, anti-spasmodic, and analgesic properties, it is also widely used for treating gastroenteritis and indigestion.

Also known as: Foeniculum vulgare

fennel group

Eligibility Criteria

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

You may qualify if:

• Completely dentate individuals
• Males \& Females Patients ≥ 18 years
• Individuals not undergoing topical fluoride therapy, other chemotherapeutic procedures, antibiotics, and drugs having an effect upon the salivary function or salivary pH
• Individuals not suffering from any systemic diseases/ taking any medication that affects the salivary secretion

You may not qualify if:

• Patients suffering from systemic diseases
• Patients taking drugs that can effect ph. of saliva
• Patients less then18 years of age -

Sponsors & Collaborators

• University of Karachi: lead
• Altamash Institute of Dental Medicine: collaborator

Study Sites (1)

Altamash Institute of Dental Medicine

Karachi, Sindh, 75500, Pakistan

Location

Related Publications (1)

• Manohar R, Ganesh A, Abbyramy N, Abinaya R, Balaji SK, Priya SB. The effect of fennel seeds on pH of saliva - A clinical study. Indian J Dent Res. 2020 Nov-Dec;31(6):921-923. doi: 10.4103/ijdr.IJDR_185_19.

  PMID: 33753665 BACKGROUND

MeSH Terms

Interventions

Foeniculum vulgare fruit

Study Officials

• RABIA ARSHAD, Ph.D

  ALTAMASH INSTITUTE OF DENTAL MEDICINE, KARACHI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor and Head, Department of Pharmacology, Altamash Institute of Dental Medicines. Karachi

Model Details: Males \& Females Patients ≥ 18 years Individuals not undergoing topical fluoride therapy, other chemotherapeutic procedures, antibiotics, and drugs having an effect upon the salivary function or salivary pH Individuals not suffering from any systemic diseases/ taking any medication that affects salivary secretion

Study Record Dates

• First Submitted: January 25, 2022
• First Posted: February 17, 2022
• Study Start: February 1, 2022
• Primary Completion: March 28, 2022
• Study Completion: March 31, 2022
• Last Updated: May 24, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)