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

September 8, 2018 updated by: Randa Abdelrahman, Cairo University

Effect of Propolis and Pomegranate Extract Mouthwash on Taste Alteration, Salivary pH and Antibacterial Activity in High Caries Risk Patients

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

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

17 years to 50 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

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
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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 Names:
  • hexitol
PLACEBO_COMPARATOR: Saline
comparator
Other: saline
anti-inflammatory cleansing mouthwash
Other Names:
  • NaCl solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Taste alteration
Time Frame: One week
taste changes will be measured by a questionnaire
One week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Salivary pH
Time Frame: one week
salivary pH will be measured by digital pH meter
one week

Collaborators and Investigators

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

Sponsor

Cairo University

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)

March 1, 2019

Primary Completion (ANTICIPATED)

April 1, 2019

Study Completion (ANTICIPATED)

April 1, 2019

Study Registration Dates

First Submitted

August 7, 2018

First Submitted That Met QC Criteria

August 8, 2018

First Posted (ACTUAL)

August 9, 2018

Study Record Updates

Last Update Posted (ACTUAL)

September 11, 2018

Last Update Submitted That Met QC Criteria

September 8, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEBD-CU-2018-08-04

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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