Using a Mouthwash Containing Propolis, Clove Oil and Chlorhexidine to Improve the Caries Risk of High Risk Patients

December 30, 2020 updated by: Moataz Gamal Ali Abdul-Maksoud Konsouh

Using a Mouthwash Containing Propolis, Clove Oil and Chlorhexidine to Improve the Caries Risk of High Risk Patients: Randomized Clinical Trial

This study is conducted to determine if using a mouthwash containing propolis, clove oil and chlorhexidine will improve the caries risk of high risk patients in comparison to using a mouthwash containing chlorhexidine only.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A total of 64 patients will be assigned in this study. Patients will be randomly divided into two groups according to type of mouthwash (A) where group A1 patients will use chlorhexidine mouthwash as control group while group A2 patients will use chlorhexidine with propolis and clove oil mouthwash as intervention group with 32 patients in each group. Each group will be further divided into two groups according to times of application (T) where T1 represents patients using the mouthwash once daily for one week every month for 6 months and T2 where patients will use the mouthwash twice daily for one week every month for 6 months with 16 patients in each subgroup.

Study Type

Interventional

Enrollment (Actual)

64

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.

Study Locations

  • Egypt
      • Cairo, Egypt, 12613
        • Conservative Dentistry Department Out-Patient Clinic

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients should be over 18 years of age.
  • Patients should be with high caries risk assessment.

Exclusion Criteria:

  • Patients with a compromised medical history.
  • Severe or active periodontal disease.
  • Patients with a diseased salivary gland
  • History of allergies or other adverse reactions to chlorhexidine, propolis, bee stings, or clove
  • Patients on any antibiotics during the past month

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: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Chlorhexidine Once Daily
Chlorhexidine HCL 0.12% mouthwash to be used once daily for one week each month for six months
Other: Chlorhexidine mouthwash
Chlorhexidine HCL 0.12% mouthwash
ACTIVE_COMPARATOR: Chlorhexidine Twice Daily
Chlorhexidine HCL 0.12% mouthwash to be used twice daily for one week each month for six months
Other: Chlorhexidine mouthwash
Chlorhexidine HCL 0.12% mouthwash
EXPERIMENTAL: Propolis Once Daily
Chlorhexidine Gluconate 0.12% with Propolis 1% and Clove Oil 1% mouthwash to be used once daily for one week each month for six months
Other: Chlorhexidine, Propolis and Clove Oil mouthwash
Chlorhexidine Gluconate 0.12% with Propolis 1% and Clove Oil 1% mouthwash
EXPERIMENTAL: Propolis Twice Daily
Chlorhexidine Gluconate 0.12% with Propolis 1% and Clove Oil 1% mouthwash to be used twice daily for one week each month for six months
Other: Chlorhexidine, Propolis and Clove Oil mouthwash
Chlorhexidine Gluconate 0.12% with Propolis 1% and Clove Oil 1% mouthwash

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Caries Risk Assessment
Time Frame: 6 month
Patient caries risk assessment will be measured using the cariogram model
6 month

Collaborators and Investigators

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

Sponsor

Moataz Gamal Ali Abdul-Maksoud Konsouh

Collaborators

Cairo University

Investigators

  • Study Director: Mohammad A Ezzat, Ph.D., 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

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 (ACTUAL)

August 1, 2018

Primary Completion (ACTUAL)

January 31, 2019

Study Completion (ACTUAL)

March 1, 2019

Study Registration Dates

First Submitted

May 30, 2018

First Submitted That Met QC Criteria

May 30, 2018

First Posted (ACTUAL)

June 12, 2018

Study Record Updates

Last Update Posted (ACTUAL)

January 5, 2021

Last Update Submitted That Met QC Criteria

December 30, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • oper252215

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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