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Completed

NCT Number: NCT03553628

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

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.

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Key information

Conditions

Caries, Dental Behavior Dental Caries Risk Reduction Risk Reduction Behavior Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Conservative Dentistry Department Out-Patient Clinic

Cairo, 12613, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chlorhexidine, Propolis and Clove Oil mouthwash

Other

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

Chlorhexidine mouthwash

Other

Chlorhexidine HCL 0.12% mouthwash

Primary outcomes

  1. Caries Risk Assessment

    Time frame: 6 month

    Patient caries risk assessment will be measured using the cariogram model

Sponsors and collaborators

Lead sponsor

Moataz Gamal Ali Abdul-Maksoud Konsouh

Other

Collaborators

  • Cairo University

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 12, 2018
Registry last updated
Jan 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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