NCT03061916

Brief Summary

Chlorhexidine is the most potent chemotherapeutic agent against mutans streptococci and dental caries, however, the incidence of side effects such as teeth discoloration, staining of restorations, undesirable taste, discoloration of tongue, dryness and burning sensation in the mouth discourage patients to use this mouth wash. Natural products are now preferred by a large proportion of the population and have been reported to possess antimicrobial activity.These products have recently been shown to be a good alternative to synthetic chemical substances for caries prevention like Cinnamon and Ginger. The aim of this study is to compare the antimicrobial effects of aqueous extracts of cinnamon 20% and ginger 20% in comparison to chlorhexidine gluconate 0.2% on oral streptococcus mutans

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
21

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2017

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
6 days until next milestone

Study Start

First participant enrolled

March 1, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

2 months

First QC Date

February 15, 2017

Last Update Submit

February 19, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • viability count measurement

    The number of colonies will be expressed as colony-forming units multiplied by the dilution factor per milliliter of saliva (CFU/ml) and compared before and after rinsing

    within two hours

Study Arms (3)

Cinnamon

EXPERIMENTAL

20% cinnamon will be given after collection of saliva (baseline) and samples will be taken after 30 minutes , one hour and two hours of giving cinnamon 20%

Dietary Supplement: Cinnamon

Ginger

EXPERIMENTAL

20% ginger will be given after collection of saliva (baseline) and samples will be taken after 30 minutes , one hour and two hours of giving ginger 20%

Dietary Supplement: Ginger

Chlorhexidine

ACTIVE COMPARATOR

Chlorhexidine gluconate 0.2%,will be given after collection of saliva (baseline) and samples will be taken after 30 minutes , one hour and two hours of giving chlorhexidine.

Drug: Chlorhexidine Gluconate

Interventions

CinnamonDIETARY_SUPPLEMENT

Cinnamon 20% will be given to participants after baseline collection of saliva

Also known as: Cinnamomum zeylanicum
Cinnamon
GingerDIETARY_SUPPLEMENT

Ginger 20% will be given to participants after baseline collection of saliva

Also known as: Z. officinale
Ginger

Chlorhexidine Gluconate will be given to participants after baseline collection of saliva

Chlorhexidine

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Normal adults will be recruited in this study, all the volunteers participated in this experiment will be healthy looking with free medical history. The volunteers will be asked to suspend their usual oral hygiene practice at the day of the experiment

You may not qualify if:

  • Volunteers that receives any antimicrobial agents during the last two weeks prior to study , wearing any fixed or removable prosthesis or orthodontic appliance will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nadhel Ahmed Mukred Mohamed

Cairo Governorate, Cairo Governorate, Egypt

Location

Related Publications (5)

  • Azizi A, Aghayan S, Zaker S, Shakeri M, Entezari N, Lawaf S. In Vitro Effect of Zingiber officinale Extract on Growth of Streptococcus mutans and Streptococcus sanguinis. Int J Dent. 2015;2015:489842. doi: 10.1155/2015/489842. Epub 2015 Aug 12.

  • Hasan S, Danishuddin M, Khan AU. Inhibitory effect of zingiber officinale towards Streptococcus mutans virulence and caries development: in vitro and in vivo studies. BMC Microbiol. 2015 Jan 16;15(1):1. doi: 10.1186/s12866-014-0320-5.

  • Weli, Tuqa Akram, and Ahlam Taha Mohammed. Effect of ginger extract on Mutans streptococci in comparison to chlorhexidine gluconate. Journal of Baghdad College of Dentistry 25.2 (2013): 179-184.

    RESULT
  • Al-Duboni, Ghada, Muhamed T. Osman, and R. Al-Naggar. Antimicrobial activity of aqueous extracts of cinnamon and ginger on two oral pathogens causing dental caries. Research Journal of Pharmaceutical, Biological and Chemical Sciences 4 (2013): 957-965.

    RESULT
  • Rashad, J. M. Effect of water cinnamon extract on mutans streptococci, in comparison to chlorhexidine gluconate and zac (in vitro and in vivo study). Mustansiria Dent J 5 (2008): 250-60.

    RESULT

MeSH Terms

Conditions

Dental Caries

Interventions

ginger extractchlorhexidine gluconate

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Heba Hamza, PhD

    Cairo university, Professor of conservative dentistry

    STUDY DIRECTOR
  • Mai Mamdouh, PhD

    Cairo university, lecturer of conservative dentistry

    STUDY CHAIR

Central Study Contacts

Nadhel A Mohamed, Master

CONTACT

Nadhel Mohamed, Master

CONTACT

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master candidate at Conservative department

Study Record Dates

First Submitted

February 15, 2017

First Posted

February 23, 2017

Study Start

March 1, 2017

Primary Completion

May 1, 2017

Study Completion

November 1, 2017

Last Updated

February 23, 2017

Record last verified: 2017-02

Locations