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Effect of Natural Antibacterial Mouthwash on Taste, Salivary pH and Bacteria in High Caries Risk pt

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ClinicalTrials.gov Identifier: NCT03623048
Recruitment Status : Unknown
Verified September 2018 by Randa Abdelrahman, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : August 9, 2018
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
Randa Abdelrahman, Cairo University

Study Description
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Brief Summary:
Evaluate the effect of propolis extract mouthwash and pomegranate extract mouthwash on taste alteration, salivary pH and antibacterial activity against streptococcus mutans in high caries risk patients.

Condition or disease Intervention/treatment Phase
Decay, Dental Other: chlorhexidine Other: saline Other: Propolis extract Other: pomegranate extract Not Applicable

Detailed Description:

This study will be carried out to evaluate and compare the effect of propolis extract mouthwash and pomegranate (botanical name: Punica granatum) extract mouthwash on taste alteration, salivary pH and antibacterial activity against streptococcus mutans in high caries risk patients.

Thats by taking unstimulated saliva samples at the morning before using the mouthwash, then taking another one after using the mouthwash and finally after 7 days, to make a bacterial culture and measure the salivary pH by a digital pH meter and evaluate taste changes by a questionnaire.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Propolis and Pomegranate Extract Mouthwash on Taste Alteration, Salivary pH and Antibacterial Activity in High Caries Risk Patients
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Propolis extract
intervention
 Other: Propolis extract
antibacterial mouthwash
Experimental: Pomegranate extract
intervention
 Other: pomegranate extract
antibacterial mouthwash
Active Comparator: Chlorhexidine
comparator
 Other: chlorhexidine
antibacterial and anti-inflammatory mouthwash
Other Name: hexitol
Placebo Comparator: Saline
comparator
 Other: saline
anti-inflammatory cleansing mouthwash
Other Name: NaCl solution


Outcome Measures
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Primary Outcome Measures :
  1. Taste alteration [ Time Frame: One week ]
    taste changes will be measured by a questionnaire


Secondary Outcome Measures :
  1. Salivary pH [ Time Frame: one week ]
    salivary pH will be measured by digital pH meter


Eligibility Criteria
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Ages Eligible for Study:   17 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • High caries risk patients defined according to American Dental Association (ADA)
  • Systematically healthy
  • Not taking any medication interfering with saliva secretion
  • Subjects who signed informed consent
  • Age range from 17-50 years

Exclusion Criteria:

  • Subjects suffering from any medical or systematic disease
  • Smokers
  • Pregnant females
  • Allergy to any of the mouthwash ingredients
  • Patients older than 50 years
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Responsible Party: Randa Abdelrahman, Assistant lecturer, Cairo University
ClinicalTrials.gov Identifier: NCT03623048    
Other Study ID Numbers: CEBD-CU-2018-08-04
First Posted: August 9, 2018    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018

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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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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Chlorhexidine
 Propolis
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants