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
NCT number | NCT03553628 |
Other study ID # | oper252215 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 1, 2018 |
Est. completion date | March 1, 2019 |
Verified date | December 2020 |
Source | Cairo University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Egypt | Conservative Dentistry Department Out-Patient Clinic | Cairo |
Lead Sponsor | Collaborator |
---|---|
Moataz Gamal Ali Abdul-Maksoud Konsouh | Cairo University |
Egypt,
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
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Caries Risk Assessment | Patient caries risk assessment will be measured using the cariogram model | 6 month |
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