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

NCT ID: NCT05245019

Last Updated: 2022-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2022-03-31

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.

Detailed Description

This study has been designed to evaluate the effects of cardamom and fennel on oral pH and microbes of the oral cavity.

OBJECTIVES OF THE STUDY:

1. To compare the change in pH of the saliva before and after Cardamom use

2. To compare the change in pH of the saliva before and after Fennel use

3. To compare the pH changes after fennel and cardamom use on patients' saliva

4. To evaluate the effects of Cardamom extract on oral pathogens (S. mutans and Lactobacillus)

5. To evaluate the effects of Fennel extract on oral pathogens

6. To compare the effects of Cardamom and Fennel extract on oral pathogens.

STUDY DESIGN:

Randomized clinical trial

INCLUSION CRITERIA:

1. Completely dentate individuals

2. Males & Females Patients ≥ 18 years

3. Individuals not undergoing topical fluoride therapy, other chemotherapeutic procedures, antibiotics, and drugs affecting the salivary function or salivary pH

4. Individuals not suffering from any systemic diseases/ taking any medication that affects salivary secretion (14).

METHODOLOGY:

Patients coming to the dental setting for a dental checkup or dental procedures, after written informed consent will be enrolled in the study. They will be requested not to take anything orally except plain water for an hour. After an hour they will be required to give salivary samples as control first (control salivary samples). pH will be measured of provided salivary samples with a portable digital pH meter.

Afterward, divided randomly into groups A with a minimum of 25 patients will be given Cardamom (one pod). The second group, Group B will be given Fennel (half teaspoon full, 1.3 grams) to be chewed for 10 minutes under the supervision of the researcher. The saliva will again be collected in clean containers and pH will be assessed.

For the second part of the study, the extract will be prepared with ten grams of fruit powder to be kept in 70% methanol (100ml) for 3 days, followed by filtration and proper storage. Bacteria will be grown from control salivary samples on the required agars. With micro-pathological techniques and expertise, the extract will be applied to the agar and the zone of inhibition will be measured in millimeters on inoculated agar plates with the agar well diffusion method. Standard strains as control will be taken from DDRL Lab. For positive control, Tablet Ciprofloxacin will be used. (12).

Data collected will be evaluated statistically using SPSS 26. For numerical values, mean with standard deviation, and for categorical values percentages will be calculated. To compare before and after paired T-test and to compare between the two treatments, students' T-test will be applied. A value equal to and greater than 0.05 will be considered significant.

Conditions

Electrolyte Disturbance; Saliva Altered

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

cardamom group

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

Group Type: EXPERIMENTAL

cardamom

Intervention Type: BIOLOGICAL

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

fennel group

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

Group Type: EXPERIMENTAL

fennel

Intervention Type: BIOLOGICAL

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

Interventions

cardamom

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

Intervention Type: BIOLOGICAL

fennel

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

Intervention Type: BIOLOGICAL

Other Intervention Names

Elettaria cardamomum; Foeniculum vulgare

Eligibility Criteria

Inclusion Criteria

1. Completely dentate individuals

2. Males & Females Patients ≥ 18 years

3. Individuals not undergoing topical fluoride therapy, other chemotherapeutic procedures, antibiotics, and drugs having an effect upon the salivary function or salivary pH

4. Individuals not suffering from any systemic diseases/ taking any medication that affects the salivary secretion

Exclusion Criteria

1. Patients suffering from systemic diseases

2. Patients taking drugs that can effect ph. of saliva

3. Patients less then18 years of age -

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Altamash Institute of Dental Medicine

OTHER

Sponsor Role: collaborator

University of Karachi

OTHER

Sponsor Role: lead

Responsible Party

Dr Rabia Arshad

Associate Professor and Head, Department of Pharmacology, Altamash Institute of Dental Medicines. Karachi

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

RABIA ARSHAD, Ph.D

Role: PRINCIPAL_INVESTIGATOR

ALTAMASH INSTITUTE OF DENTAL MEDICINE, KARACHI

Locations

Altamash Institute of Dental Medicine

Karachi, Sindh, Pakistan

Countries

Pakistan

References

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.

Reference Type: BACKGROUND

PMID: 33753665 (View on PubMed)

Other Identifiers

AIDM

Identifier Type: -

Identifier Source: org_study_id