EFFICACY OF MORUS ALBA FRUIT EXTRACTS AND CHLORHEXIDINE ON SALIVARY STREPTOCOCCUS MUTANS AND pH LEVELS

NCT05052775 | Completed DMC

• 1 other identifier: 2380720EMOM
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Dental caries is highly prevalent across the globe including Pakistan and is associated with tooth loss, malocclusion and temporomandibular joint problems and sometimes may cause life threatening infections. Streptococcus mutans is considered to be one of the major pathogen responsible for the development of dental caries. As treatment of dental carries is quite expensive, main focus is on the prevention of dental carries. Chlorhexidine is the gold standard mouthwash used for the prevention of dental carries but its use has been associated with certain side effects including staining of teeth, burning sensation and a bitter taste in the oral cavity. Many populations use medicinal plants as traditional or alternative treatments for various ailments due to their better safety profiles, health beneficial effects, lower cost and easy availability. Among the plant species used for medicinal purposes are those of the genus Morus. Its most commonly used species are Morus alba, rubra and nigra that have also shown antimicrobial properties against various infections in addition to other health promoting effects. Moreover, morus alba fruit has not been evaluated for its antimicrobial activity against oral pathogens including streptococcus mutans. The purpose of this study is to evaluate the antimicrobial properties against salivary streptococcus mutans and alteration of pH in the saliva of patients with dental caries before and after the use of chlorhexidine and morus alba fruit extract mouthwashes. This study is double blinded randomised clinical trial. Sample size is calculated according to open Epi calculator and came out as 1 in each group. We will take sample size as 120 and the sampling technique will be non-probability consecutive sampling. Morus alba extract preparation will be done in the Botany department of Lasbella University of Agriculture, Water and Marine Sciences (LUAWMS) Balochistan. According to inclusion criteria and after obtaining informed consents, samples of saliva of the individuals of 18-40 year of both genders will be collected from the OPD of Dentistry department, Civil hospital Uthal Balochistan at the beginning of the study and two weeks after the treatments. The total 120 subjects will be equally divided into three groups, 40 participants in each group (A, B and C). The subjects in group A will be given chlorhexidine mouthwash and the subjects in group B and C will be given 20% and 30% aqueous extracts of morus alba fruit in the form of mouthwashes respectively. The samples of saliva will be analysed for S.mutans counts and pH levels at baseline and 15 days after the use of respective mouthwash. Culture procedure for S.mutans count will be Dilution and Spread plate technique.

Conditions

Dental Caries

Keywords

Dental Caries; Chlorhexidine; Morus Alba

Outcome Measures

Primary Outcomes (1)

• count of bacteria (streptococcus mutans)will be decrease

  streptococcus mutans is the dental caries causing microorganism, in this study, the count of streptococcus mutans is measured before and after the use of respective mouthwash,the bacterial count decrease after the use of mouthwash, so primary outcome is that there is less chance of dental caries after use of respective mouthwash

  15 days

Study Arms (3)

Chlorhexidine Group

ACTIVE COMPARATOR

These patients were control group given chlorhexidine mouthwash 2 times per day for 15 days

Other: Chlorhexidine Mouthwash

Morus Alba 20%

EXPERIMENTAL

Patients were given morus alba 20% concentration 2 times per day for 15 days

Other: Morus Alba 20%

Morus Alba 30%

EXPERIMENTAL

Patients were given morus alba 30% concentration 2 times per day for 15 days

Other: Morus Alba 30%

Interventions

Chlorhexidine Mouthwash OTHER

Patients were given chlorhexidine mouthwash 2 times per day for 15 days

Chlorhexidine Group

Morus Alba 20% OTHER

Patients were given morus alba 20% concentration 2 times per day for 15 days

Morus Alba 20%

Morus Alba 30% OTHER

Patients were given morus alba 30% concentration 2 times per day for 15 days

Morus Alba 30%

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• All the patients of age 18-40 years at least 20 teeth in their mouth and not including wisdom teeth.
• The patients of either gender. The patients with active and untreated carious lesions, (at least one carious tooth should be present in patient oral cavity).

You may not qualify if:

• The patients undergoing orthodontic treatment The patients already taking antibiotic therapy or antimicrobial rinse. The patients having allergy to chlorhexidine mouthwash The patients whose consents could not be obtained

Sponsors & Collaborators

• Ziauddin University: lead

Study Sites (1)

Ziauddin University

Karachi, Sindh, 75600, Pakistan

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Eid Muhammad, MPHIL

  Ziauddin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Total number of groups = 3 Group 1 has been given chlorhexidine mouthwash and group 2nd and 3rd have been given 20% and 30% aqueous extract of morus alba fruit respectively.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.Phil Trainee

Study Record Dates

• First Submitted: September 12, 2021
• First Posted: September 22, 2021
• Study Start: October 20, 2020
• Primary Completion: February 4, 2021
• Study Completion: April 3, 2021
• Last Updated: September 22, 2021

Record last verified: 2021-09

Locations

PA (1)