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

Primary Purpose

Caries, Dental, Risk Reduction

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Chlorhexidine, Propolis and Clove Oil mouthwash

Chlorhexidine mouthwash

About this trial

This is an interventional prevention trial for Caries, Dental focused on measuring dental caries, propolis, chlorhexidine, clove oil, bee wax

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Conservative Dentistry Department Out-Patient Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Arm Label

Chlorhexidine Once Daily

Chlorhexidine Twice Daily

Propolis Once Daily

Propolis Twice Daily

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Caries Risk Assessment

Patient caries risk assessment will be measured using the cariogram model

Secondary Outcome Measures

Full Information

NCT ID

NCT03553628

First Posted

May 30, 2018

Last Updated

December 30, 2020

Sponsor

Moataz Gamal Ali Abdul-Maksoud Konsouh

Collaborators

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT03553628

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Completed

Study Start Date

August 1, 2018 (Actual)

Primary Completion Date

January 31, 2019 (Actual)

Study Completion Date

March 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Moataz Gamal Ali Abdul-Maksoud Konsouh

Collaborators

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Caries, Dental, Risk Reduction

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Masking

ParticipantCare ProviderInvestigatorOutcomes 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.

Allocation

Randomized

Enrollment

64 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Chlorhexidine Once Daily

Arm Type

Active Comparator

Arm Description

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

Arm Title

Chlorhexidine Twice Daily

Arm Type

Active Comparator

Arm Description

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

Arm Title

Propolis Once Daily

Arm Type

Experimental

Arm Description

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

Arm Title

Propolis Twice Daily

Arm Type

Experimental

Arm Description

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 Type

Other

Intervention Name(s)

Chlorhexidine, Propolis and Clove Oil mouthwash

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Chlorhexidine mouthwash

Intervention Description

Chlorhexidine HCL 0.12% mouthwash

Primary Outcome Measure Information:

Title

Caries Risk Assessment

Description

Patient caries risk assessment will be measured using the cariogram model

Time Frame

6 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mohammad A Ezzat, Ph.D.

Organizational Affiliation

Cairo University

Official's Role

Study Director

Facility Information:

Facility Name

Conservative Dentistry Department Out-Patient Clinic

City

Cairo

ZIP/Postal Code

12613

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

16772072

Citation

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.

Results Reference

background

PubMed Identifier

19051866

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.

Results Reference

background

PubMed Identifier

19089172

Citation

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.

Results Reference

background

PubMed Identifier

10230103

Citation

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.

Results Reference

background

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.

Results Reference

background

PubMed Identifier

25206182

Citation

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.

Results Reference

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PubMed Identifier

21369995

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].

Results Reference

background

PubMed Identifier

19422903

Citation

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.

Results Reference

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PubMed Identifier

24494174

Citation

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.

Results Reference

background

PubMed Identifier

14158464

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. doi: 10.3109/00016356408993968. No abstract available.

Results Reference

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

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