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出境医 / 临床实验 / 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

Study Description
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual 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
Actual Study Start Date : August 1, 2018
Actual Primary Completion Date : January 31, 2019
Actual Study Completion Date : March 1, 2019
Arms and Interventions
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
Outcome Measures
Primary Outcome Measures :
  1. Caries Risk Assessment [ Time Frame: 6 month ]
    Patient caries risk assessment will be measured using the cariogram model


Eligibility Criteria
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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
Contacts and Locations

Locations
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Egypt
Conservative Dentistry Department Out-Patient Clinic
Cairo, Egypt, 12613
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
Tracking Information
First Submitted Date  ICMJE May 30, 2018
First Posted Date  ICMJE June 12, 2018
Last Update Posted Date January 5, 2021
Actual Study Start Date  ICMJE August 1, 2018
Actual Primary Completion Date January 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 30, 2018) 		Caries Risk Assessment [ Time Frame: 6 month ]
Patient caries risk assessment will be measured using the cariogram model
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Using a Mouthwash Containing Propolis, Clove Oil and Chlorhexidine to Improve the Caries Risk of High Risk Patients
Official Title  ICMJE Using a Mouthwash Containing Propolis, Clove Oil and Chlorhexidine to Improve the Caries Risk of High Risk Patients: Randomized Clinical Trial
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Caries, Dental
  • Risk Reduction
Intervention  ICMJE
  • Other: Chlorhexidine, Propolis and Clove Oil mouthwash
    Chlorhexidine Gluconate 0.12% with Propolis 1% and Clove Oil 1% mouthwash
  • Other: Chlorhexidine mouthwash
    Chlorhexidine HCL 0.12% mouthwash
Study Arms  ICMJE
  • Active Comparator: Chlorhexidine Once Daily
    Chlorhexidine HCL 0.12% mouthwash to be used once daily for one week each month for six months
    Intervention: Other: Chlorhexidine mouthwash
  • Active Comparator: Chlorhexidine Twice Daily
    Chlorhexidine HCL 0.12% mouthwash to be used twice daily for one week each month for six months
    Intervention: Other: Chlorhexidine 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
    Intervention: Other: Chlorhexidine, Propolis and Clove Oil 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
    Intervention: Other: Chlorhexidine, Propolis and Clove Oil mouthwash
Publications *
  • Alian AY, McNally ME, Fure S, Birkhed D. Assessment of caries risk in elderly patients using the Cariogram model. J Can Dent Assoc. 2006 Jun;72(5):459-63.
  • Autio-Gold J. The role of chlorhexidine in caries prevention. Oper Dent. 2008 Nov-Dec;33(6):710-6. doi: 10.2341/08-3. Review.
  • Duailibe SA, Gonçalves AG, Ahid FJ. Effect of a propolis extract on Streptococcus mutans counts in vivo. J Appl Oral Sci. 2007 Oct;15(5):420-3.
  • Eley BM. Antibacterial agents in the control of supragingival plaque--a review. Br Dent J. 1999 Mar 27;186(6):286-96. Review.
  • 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.
  • Hegde KS, Bhat SS, Rao A, Sain S. Effect of Propolis on Streptococcus mutans Counts: An in vivo Study. Int J Clin Pediatr Dent. 2013 Jan;6(1):22-5. doi: 10.5005/jp-journals-10005-1180. Epub 2013 Apr 26.
  • Kim MJ, Kim CS, Kim BH, Ro SB, Lim YK, Park SN, Cho E, Ko JH, Kwon SS, Ko YM, Kook JK. Antimicrobial effect of Korean propolis against the mutans streptococci isolated from Korean. J Microbiol. 2011 Feb;49(1):161-4. doi: 10.1007/s12275-011-1002-8. Epub 2011 Mar 3. Erratum in: J Microbiol. 2011 Apr;49(2)327. Cho, Engene [corrected to Cho, Eugene].
  • Libério SA, Pereira AL, Araújo MJ, Dutra RP, Nascimento FR, Monteiro-Neto V, Ribeiro MN, Gonçalves AG, Guerra RN. The potential use of propolis as a cariostatic agent and its actions on mutans group streptococci. J Ethnopharmacol. 2009 Aug 17;125(1):1-9. doi: 10.1016/j.jep.2009.04.047. Epub 2009 May 5. Review.
  • Anauate Netto C, Marcucci MC, Paulino N, Anido-Anido A, Amore R, de Mendonça S, Borelli Neto L, Bretz WA. Effects of typified propolis on mutans streptococci and lactobacilli: a randomized clinical trial. Braz Dent Sci. 2013 Apr 1;16(2):31-36.
  • SILNESS J, LOE H. PERIODONTAL DISEASE IN PREGNANCY. II. CORRELATION BETWEEN ORAL HYGIENE AND PERIODONTAL CONDTION. Acta Odontol Scand. 1964 Feb;22:121-35.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 30, 2018) 		64
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 1, 2019
Actual Primary Completion Date January 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03553628
Other Study ID Numbers  ICMJE oper252215
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Moataz Gamal Ali Abdul-Maksoud Konsouh, Cairo University
Study Sponsor  ICMJE Moataz Gamal Ali Abdul-Maksoud Konsouh
Collaborators  ICMJE Cairo University
Investigators  ICMJE
Study Director: Mohammad A Ezzat, Ph.D. Cairo University
PRS Account Cairo University
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP