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

Sponsor

Cairo University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03623048

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Decay, Dental	Other: chlorhexidine Other: saline Other: Propolis extract Other: pomegranate extract	N/A

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

Study Type:

Interventional

Anticipated 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

Anticipated Study Start Date :

Mar 1, 2019

Anticipated Primary Completion Date :

Apr 1, 2019

Anticipated Study Completion Date :

Apr 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Taste alteration [One week]
taste changes will be measured by a questionnaire

Secondary Outcome Measures

Salivary pH [one week]
salivary pH will be measured by digital pH meter

Eligibility Criteria

Criteria

Ages Eligible for Study:

17 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

No locations specified.

Sponsors and Collaborators

Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Randa Abdelrahman, Assistant lecturer, Cairo University

ClinicalTrials.gov Identifier:

NCT03623048

Other Study ID Numbers:

CEBD-CU-2018-08-04

First Posted:

Aug 9, 2018

Last Update Posted:

Sep 11, 2018

Last Verified:

Sep 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Dental Caries

Chlorhexidine

Propolis

Study Results

No Results Posted as of Sep 11, 2018