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

Risk Reduction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03553628
• Other study ID #: oper252215
• Status: Completed
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: March 1, 2019

Study information

• Verified date: December 2020
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: March 1, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Caries, Dental
• Dental Caries
• Risk Reduction

Intervention

Other:
• Chlorhexidine, Propolis and Clove Oil mouthwash
Chlorhexidine Gluconate 0.12% with Propolis 1% and Clove Oil 1% mouthwash
• Chlorhexidine mouthwash
Chlorhexidine HCL 0.12% mouthwash

Locations

Country	Name	City	State
Egypt	Conservative Dentistry Department Out-Patient Clinic	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Moataz Gamal Ali Abdul-Maksoud Konsouh	Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Eley BM. Antibacterial agents in the control of supragingival plaque--a review. Br Dent J. 1999 Mar 27;186(6):286-96. Review. — View Citation

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. — View Citation

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]. — View Citation

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. — View Citation

SILNESS J, LOE H. PERIODONTAL DISEASE IN PREGNANCY. II. CORRELATION BETWEEN ORAL HYGIENE AND PERIODONTAL CONDTION. Acta Odontol Scand. 1964 Feb;22:121-35. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Caries Risk Assessment	Patient caries risk assessment will be measured using the cariogram model	6 month