Effects of Cardamom and Fennel on Salivary pH and Anti Microbial Activity
Condition: Electrolyte Disturbance; Saliva Altered
Study type: Interventional

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.
    

Intervention name(s): cardamom; fennel
Intervention type(s): Biological; Biological
Intervention description(s): cardamom is used as a flavoring agent in foods as well as for treating various cardiovascular, gastrointestinal, and neural problems; fennel is Known for its anti-inflammatory, anti-spasmodic, and analgesic properties, it is also widely used for treating gastroenteritis and indigestion.
Other intervention name(s): Elettaria cardamomum; Foeniculum vulgare
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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
Masking: Single (Investigator)
Primary purpose: Health Services Research