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

Primary Purpose

Decay, Dental

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

chlorhexidine

saline

Propolis extract

pomegranate extract

About this trial

This is an interventional prevention trial for Decay, Dental

Eligibility Criteria

17 Years - 50 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Propolis extract

Pomegranate extract

Chlorhexidine

Saline

Arm Description

intervention

comparator

Outcomes

Primary Outcome Measures

Taste alteration

taste changes will be measured by a questionnaire

Secondary Outcome Measures

Salivary pH

salivary pH will be measured by digital pH meter

Full Information

NCT ID

NCT03623048

First Posted

August 7, 2018

Last Updated

September 8, 2018

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT03623048

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Unknown status

Study Start Date

March 2019 (Anticipated)

Primary Completion Date

April 2019 (Anticipated)

Study Completion Date

April 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Decay, Dental

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Propolis extract

Arm Type

Experimental

Arm Description

intervention

Arm Title

Pomegranate extract

Arm Type

Experimental

Arm Description

intervention

Arm Title

Chlorhexidine

Arm Type

Active Comparator

Arm Description

comparator

Arm Title

Saline

Arm Type

Placebo Comparator

Arm Description

comparator

Intervention Type

Other

Intervention Name(s)

chlorhexidine

Other Intervention Name(s)

hexitol

Intervention Description

antibacterial and anti-inflammatory mouthwash

Intervention Type

Other

Intervention Name(s)

saline

Other Intervention Name(s)

NaCl solution

Intervention Description

anti-inflammatory cleansing mouthwash

Intervention Type

Other

Intervention Name(s)

Propolis extract

Intervention Description

antibacterial mouthwash

Intervention Type

Other

Intervention Name(s)

pomegranate extract

Intervention Description

antibacterial mouthwash

Primary Outcome Measure Information:

Title

Taste alteration

Description

taste changes will be measured by a questionnaire

Time Frame

One week

Secondary Outcome Measure Information:

Title

Salivary pH

Description

salivary pH will be measured by digital pH meter

Time Frame

one week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

17 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility 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

12. IPD Sharing Statement

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

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