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

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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

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.


Condition or disease Intervention/treatment Phase
High Caries Risk Patients Antimicrobial Effect Salivary pH Patient Satisfaction to Taste Drug: Guava leaves extract Drug: Chlorhexidine Phase 2 Phase 3

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : January 2020


Arm Intervention/treatment
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 Name: Psidium guajava

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 Name: Chlorhexidine glucnate




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.



Other Outcome Measures:
  1. 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



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03773094


Contacts
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Contact: Engy MM Kassem, Master's degree 00201000687726 engy.mostafa@dentistry.cu.edu.eg
Contact: Mohamed A Khairy, PhD madelkhairy@dentistry.cu.edu.eg

Sponsors and Collaborators
Cairo University

Publications:
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Responsible Party: Engy Mostafa Magdy Abdou Ahmed Kassem, Assistant Lecturer, Cairo University
ClinicalTrials.gov Identifier: NCT03773094     History of Changes
Other Study ID Numbers: Guava leaves extract CHX
First Posted: December 12, 2018    Key Record Dates
Last Update Posted: December 12, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Chlorhexidine
Chlorhexidine gluconate
Anti-Bacterial Agents
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents