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

NCT03553628 | Completed DMC

• 1 other identifier: oper252215
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Caries, Dental; Risk Reduction

Keywords

dental caries; propolis; chlorhexidine; clove oil; bee wax

Outcome Measures

Primary Outcomes (1)

• Caries Risk Assessment

  Patient caries risk assessment will be measured using the cariogram model

  6 month

Study Arms (4)

Chlorhexidine Once Daily

ACTIVE COMPARATOR

Chlorhexidine HCL 0.12% mouthwash to be used once daily for one week each month for six months

Other: Chlorhexidine mouthwash

Chlorhexidine Twice Daily

ACTIVE COMPARATOR

Chlorhexidine HCL 0.12% mouthwash to be used twice daily for one week each month for six months

Other: Chlorhexidine mouthwash

Propolis Once Daily

EXPERIMENTAL

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

Propolis Twice Daily

EXPERIMENTAL

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

Interventions

Chlorhexidine, Propolis and Clove Oil mouthwash OTHER

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

Propolis Once Daily; Propolis Twice Daily

Chlorhexidine mouthwash OTHER

Chlorhexidine HCL 0.12% mouthwash

Chlorhexidine Once Daily; Chlorhexidine Twice Daily

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients should be over 18 years of age.
• Patients should be with high caries risk assessment.

You may not qualify if:

• 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

Sponsors & Collaborators

• Moataz Gamal Ali Abdul-Maksoud Konsouh: lead
• Cairo University: collaborator

Study Sites (1)

Conservative Dentistry Department Out-Patient Clinic

Cairo, 12613, Egypt

Location

Related 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.

  PMID: 16772072 BACKGROUND

• Autio-Gold J. The role of chlorhexidine in caries prevention. Oper Dent. 2008 Nov-Dec;33(6):710-6. doi: 10.2341/08-3.

  PMID: 19051866 BACKGROUND

• 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.

  PMID: 19089172 BACKGROUND

• 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.

  PMID: 10230103 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 25206182 BACKGROUND

• 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.

  PMID: 21369995 BACKGROUND

• 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.

  PMID: 19422903 BACKGROUND

• 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.

  PMID: 24494174 BACKGROUND

• 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.

  PMID: 14158464 BACKGROUND

MeSH Terms

Conditions

Dental Caries; Risk Reduction Behavior

Interventions

Chlorhexidine; Propolis

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Resins, Plant; Biopolymers; Polymers; Macromolecular Substances; Plant Exudates; Biological Products; Complex Mixtures

Study Officials

• Mohammad A Ezzat, Ph.D.

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Allocation of mouthwash and times of applications to groups will be done through sealed opaque sequentially numbered containers to ensure absolute concealment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Master Candidate at Conservative Department

Model Details: 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 Record Dates

• First Submitted: May 30, 2018
• First Posted: June 12, 2018
• Study Start: August 1, 2018
• Primary Completion: January 31, 2019
• Study Completion: March 1, 2019
• Last Updated: January 5, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)