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

NCT ID: NCT03553628

Last Updated: 2021-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-01

Study Completion Date

2019-03-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Caries, Dental Risk Reduction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Allocation of mouthwash and times of applications to groups will be done through sealed opaque sequentially numbered containers to ensure absolute concealment.

Study Groups

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Chlorhexidine Once Daily

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

Group Type ACTIVE_COMPARATOR

Chlorhexidine mouthwash

Intervention Type OTHER

Chlorhexidine HCL 0.12% mouthwash

Chlorhexidine Twice Daily

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

Group Type ACTIVE_COMPARATOR

Chlorhexidine mouthwash

Intervention Type OTHER

Chlorhexidine HCL 0.12% mouthwash

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

Group Type EXPERIMENTAL

Chlorhexidine, Propolis and Clove Oil mouthwash

Intervention Type OTHER

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

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

Group Type EXPERIMENTAL

Chlorhexidine, Propolis and Clove Oil mouthwash

Intervention Type OTHER

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

Interventions

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Chlorhexidine, Propolis and Clove Oil mouthwash

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

Intervention Type OTHER

Chlorhexidine mouthwash

Chlorhexidine HCL 0.12% mouthwash

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role collaborator

Moataz Gamal Ali Abdul-Maksoud Konsouh

OTHER

Sponsor Role lead

Responsible Party

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Moataz Gamal Ali Abdul-Maksoud Konsouh

Master Candidate at Conservative Department

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Mohammad A Ezzat, Ph.D.

Role: STUDY_DIRECTOR

Cairo University

Locations

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Conservative Dentistry Department Out-Patient Clinic

Cairo, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 16772072 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 19051866 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19089172 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10230103 (View on PubMed)

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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 25206182 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21369995 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19422903 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24494174 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14158464 (View on PubMed)

Other Identifiers

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oper252215

Identifier Type: -

Identifier Source: org_study_id

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