The Effect of Mouthwash Containing Pomegranate Peel Extract and Chlorhexidine Mouthwash on Bleeding on Brushing

January 23, 2018 updated by: Heba Moahmed Fouad, Cairo University

The Effect of Mouthwash Containing Pomegranate Peel Extract and Chlorhexidine Mouthwash on Bleeding on Brushing Among a Group of Egyptian Children With Full Permanent Dentition, Randomized Controlled Trial

To evaluate the clinical effectiveness of mouthwash containing pomegranate peel extract and chlorhexidine mouthwash on bleeding on brushing and counting of streptococcus mutans among a group of Egyptian children with permanent dentition.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

To evaluate the clinical effectiveness of mouthwash containing pomegranate peel extract and chlorhexidine mouthwash on bleeding on brushing and counting of streptococcus mutans among a group of Egyptian children with permanent dentition.

PICO:

Population (P): Children with full permanent dentition. Intervention (I): Pomegranates peel extract. Comparator (C): Chlorhexidine.

Outcome(O):

Primary outcome: Bleeding on brushing, criteria:Asking patient, unit:Binary. Secondary outcome:Counting streptococcus mutans, criteria: Agar plate, unit: CFUs/mL

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

12 years to 15 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • children aged 12-15 years old.
  • Cooperative children.
  • Both genders.
  • Medically free.

Exclusion Criteria:

  • Children undergoing orthodontic treatment.
  • Children using any other oral hygiene aid other than routine teeth brushing.
  • Children with known history of allergy to any mouth rinse or drug.
  • Parents unable to give informed consent.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pomegranate peel extract
Pomegranate is antimicrobial, anti inflammatory and antioxidant
Drug: Pomegranates peel extract
Pomegranate is antimicrobial
Active Comparator: Chlorhexidine
Chlorhexidine mouthwash is antiplaque treatment and effective against gingivitis
Drug: Chlorhexidine
Chlorhexidine mouthwash is antiplaque agent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Bleeding on brushing, Measurement: asking patient , Unit: Binary
Time Frame: 2 weeks
2 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Counting streptococcus mutans, Measurement: Agar plate, Unit: CFUs/mL
Time Frame: 2 weeks
2 weeks

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Study Director: Salah El Behery, Professor, Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

January 1, 2018

Primary Completion (Anticipated)

January 1, 2018

Study Completion (Anticipated)

February 1, 2018

Study Registration Dates

First Submitted

October 11, 2016

First Submitted That Met QC Criteria

October 18, 2016

First Posted (Estimate)

October 19, 2016

Study Record Updates

Last Update Posted (Actual)

January 24, 2018

Last Update Submitted That Met QC Criteria

January 23, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CairoE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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