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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03553628
Enrollment
64
Registered
2018-06-12
Start date
2018-08-01
Completion date
2019-03-01
Last updated
2021-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caries, Dental, Risk Reduction

Keywords

dental caries, propolis, chlorhexidine, clove oil, bee wax

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.

Interventions

OTHERChlorhexidine, Propolis and Clove Oil mouthwash

Chlorhexidine Gluconate 0.12% with Propolis 1% and Clove Oil 1% mouthwash

OTHERChlorhexidine mouthwash

Chlorhexidine HCL 0.12% mouthwash

Sponsors

Cairo University
CollaboratorOTHER
Moataz Gamal Ali Abdul-Maksoud Konsouh
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, 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.

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Caries Risk Assessment6 monthPatient caries risk assessment will be measured using the cariogram model

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026