Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05245019 |
| Other study ID # |
AIDM |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2022 |
| Est. completion date |
March 31, 2022 |
Study information
| Verified date |
May 2022 |
| Source |
University of Karachi |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
