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Mouthwash Containing Propolis, Clove Oil and Chlorhexidine Improving the Caries Risk of High Risk Patients

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ClinicalTrials.gov Identifier: NCT03553628
Recruitment Status : Not yet recruiting
First Posted : June 12, 2018
Last Update Posted : June 13, 2018
Sponsor:
Collaborator:
Cairo University
Information provided by (Responsible Party):
Moataz Gamal Ali Abdul-Maksoud Konsouh, Cairo University

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
Caries, Dental Risk Reduction Other: Chlorhexidine, Propolis and Clove Oil mouthwash Other: Chlorhexidine mouthwash Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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.
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
Estimated Study Start Date : August 1, 2018
Estimated Primary Completion Date : January 31, 2019
Estimated Study Completion Date : March 1, 2019


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




Primary Outcome Measures :
  1. Caries Risk Assessment [ Time Frame: 6 month ]
    Patient caries risk assessment will be measured using the cariogram model



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03553628


Contacts
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Contact: Moataz G Konsouh, B.D.S. +201005544888 moataz.ali@dentistry.cu.edu.eg

Sponsors and Collaborators
Moataz Gamal Ali Abdul-Maksoud Konsouh
Cairo University
Investigators
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Study Director: Mohammad A Ezzat, Ph.D. Cairo University

Publications:
Grossman, E., Retter, G., Sturzenberger, O. P., Rosa, M. D. La, Dickinson, T. D., Ferretti, G. A., … Meckel, A. H. (1986). Six-month Study of the Effects of a Chlorhexidine Mouthrinse on Gingivitis in Adults. Journal of Periodontal Research, 33-43.

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Responsible Party: Moataz Gamal Ali Abdul-Maksoud Konsouh, Master Candidate at Conservative Department, Cairo University
ClinicalTrials.gov Identifier: NCT03553628     History of Changes
Other Study ID Numbers: oper252215
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: June 13, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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, Cairo University:
dental caries
propolis
chlorhexidine
clove oil
bee wax
Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Chlorhexidine
Chlorhexidine gluconate
Propolis
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents