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

Sponsor
Moataz Gamal Ali Abdul-Maksoud Konsouh (Other)
Overall Status
Completed
CT.gov ID
NCT03553628
Collaborator
Cairo University (Other)
64
1
4
7
9.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Chlorhexidine, Propolis and Clove Oil mouthwash
  • Other: Chlorhexidine mouthwash
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
64 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model 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.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.
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Allocation of mouthwash and times of applications to groups will be done through sealed opaque sequentially numbered containers to ensure absolute concealment.
Primary Purpose:
Prevention
Official Title:
Using a Mouthwash Containing Propolis, Clove Oil and Chlorhexidine to Improve the Caries Risk of High Risk Patients: Randomized Clinical Trial
Actual Study Start Date :
Aug 1, 2018
Actual Primary Completion Date :
Jan 31, 2019
Actual Study Completion Date :
Mar 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Caries Risk Assessment [6 month]

    Patient caries risk assessment will be measured using the cariogram model

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Conservative Dentistry Department Out-Patient Clinic Cairo Egypt 12613

Sponsors and Collaborators

  • Moataz Gamal Ali Abdul-Maksoud Konsouh
  • Cairo University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Moataz Gamal Ali Abdul-Maksoud Konsouh, Master Candidate at Conservative Department, Cairo University
ClinicalTrials.gov Identifier:
NCT03553628
Other Study ID Numbers:
  • oper252215
First Posted:
Jun 12, 2018
Last Update Posted:
Jan 5, 2021
Last Verified:
Dec 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Moataz Gamal Ali Abdul-Maksoud Konsouh, Master Candidate at Conservative Department, Cairo University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 5, 2021