Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03773094
Recruitment Status : Not yet recruiting
First Posted : December 12, 2018
Last Update Posted : December 12, 2018
Sponsor:
Information provided by (Responsible Party):
Engy Mostafa Magdy Abdou Ahmed Kassem, Cairo University

Tracking Information
First Submitted Date  ICMJE December 8, 2018
First Posted Date  ICMJE December 12, 2018
Last Update Posted Date December 12, 2018
Estimated Study Start Date  ICMJE January 2019
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 11, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2018)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 11, 2018)
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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Antibacterial Effect of Guava Leaves Extract Mouthwash Compared to Chlorhexidine Mouthwash in High Caries Risk Patients
Official Title  ICMJE 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
Brief Summary

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.

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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • High Caries Risk Patients
  • Antimicrobial Effect
  • Salivary pH
  • Patient Satisfaction to Taste
Intervention  ICMJE
  • 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 Name: Psidium guajava
  • Drug: Chlorhexidine
    chemical agent used as a mouthwash against cariogenic bacteria. considered the gold standard
    Other Name: Chlorhexidine glucnate
Study Arms  ICMJE
  • Experimental: Guava leaves extract
    A natural product that is prepared as a mouthwash
    Intervention: Drug: Guava leaves extract
  • Active Comparator: Chlorhexidine
    chemical agent Chlorhexidine as a mouthwash
    Intervention: Drug: Chlorhexidine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: December 11, 2018)
94
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2020
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Engy MM Kassem, Master's degree 00201000687726 engy.mostafa@dentistry.cu.edu.eg
Contact: Mohamed A Khairy, PhD madelkhairy@dentistry.cu.edu.eg
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03773094
Other Study ID Numbers  ICMJE Guava leaves extract CHX
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Engy Mostafa Magdy Abdou Ahmed Kassem, Cairo University
Study Sponsor  ICMJE Cairo University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Cairo University
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP