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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Caries, Dental, Risk Reduction

Intervention / Treatment
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* Other: Chlorhexidine, Propolis and Clove Oil mouthwash
* Other: Chlorhexidine mouthwash


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Chlorhexidine Once Daily<br>Chlorhexidine HCL 0.12% mouthwash to be used once daily for one week each month for six months | Other: Chlorhexidine mouthwash<br>* Chlorhexidine HCL 0.12% mouthwash<br>|
| Active Comparator: Chlorhexidine Twice Daily<br>Chlorhexidine HCL 0.12% mouthwash to be used twice daily for one week each month for six months | Other: Chlorhexidine mouthwash<br>* Chlorhexidine HCL 0.12% mouthwash<br>|
| Experimental: Propolis Once Daily<br>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<br>* Chlorhexidine Gluconate 0.12% with Propolis 1% and Clove Oil 1% mouthwash<br>|
| Experimental: Propolis Twice Daily<br>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<br>* Chlorhexidine Gluconate 0.12% with Propolis 1% and Clove Oil 1% mouthwash<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dental caries, propolis, chlorhexidine, clove oil, bee wax