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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: January 31, 2019

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

  • 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

Arms, Groups and Cohorts

  • Active Comparator: Chlorhexidine Once Daily
    • Chlorhexidine HCL 0.12% mouthwash to be used once daily for one week each month for six months
  • Active Comparator: Chlorhexidine Twice Daily
    • Chlorhexidine HCL 0.12% mouthwash to be used twice daily for one week each month for six months
  • 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
  • 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

Clinical Trial Outcome Measures

Primary Measures

  • Caries Risk Assessment
    • Time Frame: 6 month
    • Patient caries risk assessment will be measured using the cariogram model

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Moataz Gamal Ali Abdul-Maksoud Konsouh
  • Collaborator
    • Cairo University
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Moataz Gamal Ali Abdul-Maksoud Konsouh, Master Candidate at Conservative Department – Cairo University
  • Overall Official(s)
    • Mohammad A Ezzat, Ph.D., Study Director, Cairo University

References

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.

Duailibe SA, Goncalves AG, Ahid FJ. Effect of a propolis extract on Streptococcus mutans counts in vivo. J Appl Oral Sci. 2007 Oct;15(5):420-3. doi: 10.1590/s1678-77572007000500009.

Eley BM. Antibacterial agents in the control of supragingival plaque–a review. Br Dent J. 1999 Mar 27;186(6):286-96. doi: 10.1038/sj.bdj.4800090.

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].

Liberio SA, Pereira AL, Araujo MJ, Dutra RP, Nascimento FR, Monteiro-Neto V, Ribeiro MN, Goncalves 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.

Anauate Netto C, Marcucci MC, Paulino N, Anido-Anido A, Amore R, de Mendonca 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. doi: 10.14295/bds.2013.v16i2.879.

SILNESS J, LOE H. PERIODONTAL DISEASE IN PREGNANCY. II. CORRELATION BETWEEN ORAL HYGIENE AND PERIODONTAL CONDTION. Acta Odontol Scand. 1964 Feb;22:121-35. doi: 10.3109/00016356408993968. No abstract available.

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