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

Not Applicable

Completed

• Conditions: Caries, Dental; Risk Reduction
• Interventions: Other: Chlorhexidine, Propolis and Clove Oil mouthwash; Other: Chlorhexidine mouthwash

• Registration Number: NCT03553628
• Lead Sponsor: Moataz Gamal Ali Abdul-Maksoud Konsouh

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.

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 Timeline

• Study First Submitted: 2018-05-30
• Study First Submitted QC: 2018-05-30
• Study First Posted: 2018-06-12
• Study Start: 2018-08-01
• Primary Completion: 2019-01-31
• Study Completion: 2019-03-01
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-30
• Last Update Posted: 2021-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Propolis Once Daily	Chlorhexidine, Propolis and Clove Oil mouthwash	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
Chlorhexidine Twice Daily	Chlorhexidine mouthwash	Chlorhexidine HCL 0.12% mouthwash to be used twice daily for one week each month for six months
Propolis Twice Daily	Chlorhexidine, Propolis and Clove Oil mouthwash	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
Chlorhexidine Once Daily	Chlorhexidine mouthwash	Chlorhexidine HCL 0.12% mouthwash to be used once daily for one week each month for six months

Primary Outcome Measures

Name	Time	Method
Caries Risk Assessment	6 month	Patient caries risk assessment will be measured using the cariogram model

Trial Locations

Locations (1)

Conservative Dentistry Department Out-Patient Clinic; 🇪🇬 Cairo, Egypt