Antibacterial Effect of Guava Leaves Extract Mouthwash Compared to Chlorhexidine Mouthwash in High Caries Risk Patients

December 11, 2018 updated by: Engy Mostafa Magdy Abdou Ahmed Kassem, Cairo University

Effect of Guava Leaves Extract Mouth Wash on Antibacterial Activity, Salivary pH and Patient Satisfaction Compared to Chlorhexidine Mouth Wash in High Caries Risk Patients: A Randomized Control Clinical Trial

This trial is to test the antibacterial effect of Guava leaves extract mouth wash compared to Chlorhexidine mouth wash in high caries risk patients.

Also salivary pH and patient satisfaction to taste will also be tested.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This study is conducted to evaluate the effect of Guava leaves extract mouth wash on anti-bacterial activity against streptococcus mutans, salivary pH and patient satisfaction to taste compared to Chlorhexidine mouth wash.

P: Population with high caries risk patients I: Intervention by Guava leaves extract mouthwash C: Control is Chlorhexidine mouthwash O1: The primary outcome is antibacterial activity. O2: The secondary outcome is salivary pH O3: The tertiary outcome is patient satisfaction to taste

Study Type

Interventional

Enrollment (Anticipated)

94

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 48 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  1. High caries risk patients
  2. 18-50 years
  3. Healthy cooperative patients
  4. Males or Females

Exclusion Criteria

  1. Medically compromised patients
  2. Patients with any systemic disease that might affect the salivary flow
  3. Allergy to any of the ingredients
  4. Patients with physical limitations that might affect normal tooth brushing and mouth rinsing
  5. Presence of intraoral infections
  6. Currently using any mouth rinse
  7. Smokers
  8. Use of antibiotics in the previous 30 days

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Chlorhexidine
chemical agent Chlorhexidine as a mouthwash
Drug: Chlorhexidine
chemical agent used as a mouthwash against cariogenic bacteria. considered the gold standard
Other Names:
  • Chlorhexidine glucnate
Experimental: Guava leaves extract
A natural product that is prepared as a mouthwash
Drug: Guava leaves extract

Natural product : The leaves of the guava tree are full of antioxidants, anti-inflammatory agents, antibacterials, and even tannins that can have significant health benefits, from treating stomach troubles to chronic diseases like cancer

•

Other Names:
  • Psidium guajava

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anti-bacterial effect against streptococcus mutans
Time Frame: 3 months
Antimicrobial effect against streptococcus mutans: saliva samples collected and total bacterial count measured after agar plates incubating, expressed in colony forming units
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Salivary pH
Time Frame: 3 months

Saliva samples pH will be measured using digital pH meter to evaluate its efficacy in preventing the action of acidogenic bacteria in high caries risk patients.

It displays numerical value.
3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction to taste: questionnaire
Time Frame: 3 months
The patient will fill a questionnaire to assess patient satisfaction to taste after usage of the mouthwash. Nominal answers
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2019

Primary Completion (Anticipated)

November 1, 2019

Study Completion (Anticipated)

January 1, 2020

Study Registration Dates

First Submitted

December 8, 2018

First Submitted That Met QC Criteria

December 11, 2018

First Posted (Actual)

December 12, 2018

Study Record Updates

Last Update Posted (Actual)

December 12, 2018

Last Update Submitted That Met QC Criteria

December 11, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Guava leaves extract CHX

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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