Dental CariesPhase 3NCT03061916
Cinnamon and Ginger in Comparison to Chlorhexidine Gluconate 0.2% on Oral Streptococcus Mutans
A Phase 3 study testing Cinnamon, Ginger and Chlorhexidine Gluconate in people with Dental Caries, run by Cairo University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Cinnamon, Ginger and Chlorhexidine Gluconate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2017to 1 Nov 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Antimicrobial Effects of Aqueous Extracts of Cinnamon and Ginger in Comparison to Chlorhexidine Gluconate 0.2% on Oral Streptococcus Mutans
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
Read the detailed description
Sample Size Calculation 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. 2 way with repeated measures analysis of variance will be performed to study the effect of different solutions at different times. Based on previous papers, a large effect size is expected (f=0.4). a minimum total sample size of 18 patients ( 6 in each group) will be sufficient with the power of 85% and a significance level of 5%. This number is to be increased to 21 to compensate for losses during follow up. The sample size was calculated using G*Power program (University of Dusseldorf, Dusseldorf, Germany). Recruitment Patient will be recruited from the outpatient clinic in the conservative department after explaining the benefits from the application of the interventions to their oral hygiene which is natural unlike other chemicals mouth rinses that has complications such as staining, and burning sensation; from which eligible patients will be recruited to fulfill the eligibility criteria.
Randomization:
Sequence generation:
Randomization will be computer generated using (www.randomization.com).
Allocation concealment:
Allocation of rinsing agents to groups will be done through sealed black opaque envelopes to ensure complete concealment.
Implementation:
A third party will perform the allocation sequence and assign the participants to rinsing agent in sequentially numbered opaque envelops.
Blinding:
The allocation group will be blinded from those assessing the outcome, data collectors, and data analysts. The microbiologists will be blinded by labeling the specimens with non-identifying terms.
Data collection methods:
Baseline data collection:
N.M will collect the baseline data through a chart which is composed of medical, dental history and clinical examination for every patient will be filled. The report will be anonymous where patients identified by their serial numbers (the first letter of the first and last name and date of birth) only will be registered. N.M will write the full detailed personal data of the patient in a separate sheet having the patient's serial number for further contact with patient, this sheet can only be seen by N.M. and the M.M.
Outcome data collection:
A microbiological technician will assess the viability counts of Mutans Streptococci in patients saliva at baseline and after 30 minutes, one hour and tow hours of rinsing.
Patient retention:
N.M. should understand the participant the final result will be expected and how it will differ in his/her oral hygiene. N.M. will told the participant that the whole procedure will take a short time and it will be painless.
Data management:
Data entry will be carried out by N.M. and revised by M.M.. All data will stored on computer and will be encrypted using a password. This will be done to allow accurate data entry through revision and protect data from being incorrectly used. Data will be packed up on another storage device to prevent it from being lost.
Statistical analysis :
Data will be analyzed using SPSS advanced statistics (Statistical Package for Social Sciences, version 21 (SPSS Inc. Chicago. IL). Numerical data will be described as mean and standard deviation or median and range. while qualitative data will be described as number and percentage. 2 way with repeated measures analysis of variance (ANOVA) will be performed. A p-value less than or equal to 0.05 will be considered statistically significant. All tests will be two tailed.
Data monitoring:
H.H. will monitor this study. Her role is to monitor any risk of bias could be done from participants, operator or assessors. Also to monitor blinding of the assessors and patient safety, outstanding benefits or harms.
Harms:
N.M. should inform participants about the possible harms, if present. Participants are allowed to contact the operator at moment through telephone. The data will be reported to N.M.
Auditing:
In the present trial, auditing will be done by the main and co-supervisors (H.H and M.M) to assure quality of the research methods and interventions. Ethics and dissemination
Research ethics approval:
Application forms for carrying out the clinical trial, checklist and informed consent of Research Ethics Committee (CREC) Faculty of Oral and Dental Medicine, Cairo University will be retrieved and filled, then will be delivered for (CREC) committee for approval, this is done to prevent any ethical problems during the study or any harm for any of the participants.
Protocol amendments:
If a new protocol will be used a protocol amendment will be submitted; containing a new copy of the new protocol and brief explanation about the differences between it and the previous protocols. If there is a change in the existing protocol that affect safety of subjects, investigation scope or scientific quality of the trial, an amendment containing a brief explanation about the change will be submitted. If a new author will be added to accomplish the study, an amendment including the investigator's data and qualifications to conduct the investigation will be submitted to prevent ghost authorship.
Consent or assent:
N.M. is responsible for admitting and signing the informed consents during the enrollment day.
Confidentiality:
Name and personal data of the participants will not appear on the protocol form and will be maintained secured for 10 years after the trial. This is done for protection of participants' privacy and civil rights.
Declaration of interests:
There is no conflict of interest, no funding or material supplying from any parties.
Access to data:
Access to final data will be allowed to the operator N.M. and main and co-supervisors (H.H. and M.M.) of the study who are involved in assessment of the outcome.
Ancillary and post-trial care:
Patients will not be followed up after intervention as there is no harm from our material we used .
Dissemination policy:
Full protocol will be published online in clinical trials website to avoid repetition and to keep the integrity of the research work. Thesis will be discussed in front of judgment committee. The study will be published to report the results of this clinical trial.
- Conditions
- Dental Caries
- Being tested
- Cinnamon, Ginger, Chlorhexidine Gluconate
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CinnamonDietary supplement
Also called Cinnamomum zeylanicum
Cinnamon 20% will be given to participants after baseline collection of saliva
GingerDietary supplement
Also called Z. officinale
Ginger 20% will be given to participants after baseline collection of saliva
Chlorhexidine GluconateDrug
Chlorhexidine Gluconate will be given to participants after baseline collection of saliva
| Study group | Role | What they receive |
|---|---|---|
| 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% Receives: 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% Receives: 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. Receives: Drug: Chlorhexidine Gluconate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: within two hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study startMar 2017 (estimated)
- Primary completion1 May 2017 (estimated)
- Study completion1 Nov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nadhel Ahmed Mukred Mohamed, Cairo University
- Investigators
- Heba Hamza, PhD, Study director, Cairo university, Professor of conservative dentistryMai Mamdouh, PhD, Study chair, Cairo university, lecturer of conservative dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03061916
- Sponsor's protocol ID
- oper 606
- Status last verified
- Feb 2017
- First submitted
- 15 Feb 2017
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 26347778Hasan 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.
PubMed 25591663Weli, 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.
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.
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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antimicrobial Effects of Aqueous Extracts of Cinnamon and Ginger in Comparison to Chlorhexidine Gluconate 0.2% on Oral Streptococcus Mutans
- ClinicalTrials.gov ID
- NCT03061916
- Acronym / sponsor ID
- oper 606
- Conditions
- Dental Caries
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Mar 2017 (estimated)
- Primary completion
- 1 May 2017 (estimated)
- Study completion
- 1 Nov 2017 (estimated)
- First posted
- 23 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Sample Size Calculation 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. 2 way with repeated measures analysis of variance will be performed to study the effect of different solutions at different times. Based on previous papers, a large effect size is expected (f=0.4). a minimum total sample size of 18 patients ( 6 in each group) will be sufficient with the power of 85% and a significance level of 5%. This number is to be increased to 21 to compensate for losses during follow up. The sample size was calculated using G*Power program (University of Dusseldorf, Dusseldorf, Germany). Recruitment Patient will be recruited from the outpatient clinic in the conservative department after explaining the benefits from the application of the interventions to their oral hygiene which is natural unlike other chemicals mouth rinses that has complications such as staining, and burning sensation; from which eligible patients will be recruited to fulfill the eligibility criteria.
Randomization:
Sequence generation:
Randomization will be computer generated using (www.randomization.com).
Allocation concealment:
Allocation of rinsing agents to groups will be done through sealed black opaque envelopes to ensure complete concealment.
Implementation:
A third party will perform the allocation sequence and assign the participants to rinsing agent in sequentially numbered opaque envelops.
Blinding:
The allocation group will be blinded from those assessing the outcome, data collectors, and data analysts. The microbiologists will be blinded by labeling the specimens with non-identifying terms.
Data collection methods:
Baseline data collection:
N.M will collect the baseline data through a chart which is composed of medical, dental history and clinical examination for every patient will be filled. The report will be anonymous where patients identified by their serial numbers (the first letter of the first and last name and date of birth) only will be registered. N.M will write the full detailed personal data of the patient in a separate sheet having the patient's serial number for further contact with patient, this sheet can only be seen by N.M. and the M.M.
Outcome data collection:
A microbiological technician will assess the viability counts of Mutans Streptococci in patients saliva at baseline and after 30 minutes, one hour and tow hours of rinsing.
Patient retention:
N.M. should understand the participant the final result will be expected and how it will differ in his/her oral hygiene. N.M. will told the participant that the whole procedure will take a short time and it will be painless.
Data management:
Data entry will be carried out by N.M. and revised by M.M.. All data will stored on computer and will be encrypted using a password. This will be done to allow accurate data entry through revision and protect data from being incorrectly used. Data will be packed up on another storage device to prevent it from being lost.
Statistical analysis :
Data will be analyzed using SPSS advanced statistics (Statistical Package for Social Sciences, version 21 (SPSS Inc. Chicago. IL). Numerical data will be described as mean and standard deviation or median and range. while qualitative data will be described as number and percentage. 2 way with repeated measures analysis of variance (ANOVA) will be performed. A p-value less than or equal to 0.05 will be considered statistically significant. All tests will be two tailed.
Data monitoring:
H.H. will monitor this study. Her role is to monitor any risk of bias could be done from participants, operator or assessors. Also to monitor blinding of the assessors and patient safety, outstanding benefits or harms.
Harms:
N.M. should inform participants about the possible harms, if present. Participants are allowed to contact the operator at moment through telephone. The data will be reported to N.M.
Auditing:
In the present trial, auditing will be done by the main and co-supervisors (H.H and M.M) to assure quality of the research methods and interventions. Ethics and dissemination
Research ethics approval:
Application forms for carrying out the clinical trial, checklist and informed consent of Research Ethics Committee (CREC) Faculty of Oral and Dental Medicine, Cairo University will be retrieved and filled, then will be delivered for (CREC) committee for approval, this is done to prevent any ethical problems during the study or any harm for any of the participants.
Protocol amendments:
If a new protocol will be used a protocol amendment will be submitted; containing a new copy of the new protocol and brief explanation about the differences between it and the previous protocols. If there is a change in the existing protocol that affect safety of subjects, investigation scope or scientific quality of the trial, an amendment containing a brief explanation about the change will be submitted. If a new author will be added to accomplish the study, an amendment including the investigator's data and qualifications to conduct the investigation will be submitted to prevent ghost authorship.
Consent or assent:
N.M. is responsible for admitting and signing the informed consents during the enrollment day.
Confidentiality:
Name and personal data of the participants will not appear on the protocol form and will be maintained secured for 10 years after the trial. This is done for protection of participants' privacy and civil rights.
Declaration of interests:
There is no conflict of interest, no funding or material supplying from any parties.
Access to data:
Access to final data will be allowed to the operator N.M. and main and co-supervisors (H.H. and M.M.) of the study who are involved in assessment of the outcome.
Ancillary and post-trial care:
Patients will not be followed up after intervention as there is no harm from our material we used .
Dissemination policy:
Full protocol will be published online in clinical trials website to avoid repetition and to keep the integrity of the research work. Thesis will be discussed in front of judgment committee. The study will be published to report the results of this clinical trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cinnamon | Experimental | Dietary Supplement: Cinnamon20% 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% |
| Ginger | Experimental | Dietary Supplement: Ginger20% 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% |
| Chlorhexidine | Active comparator | Drug: Chlorhexidine GluconateChlorhexidine 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CinnamonAlso: Cinnamomum zeylanicumCinnamon 20% will be given to participants after baseline collection of saliva | Dietary supplement | Cinnamon |
| GingerAlso: Z. officinaleGinger 20% will be given to participants after baseline collection of saliva | Dietary supplement | Ginger |
| Chlorhexidine GluconateChlorhexidine Gluconate will be given to participants after baseline collection of saliva | Drug | Chlorhexidine |
Primary outcome
viability count measurement
Time frame: within two hours
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Results publication: PubMed 26347778Azizi 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.
- Results publication: PubMed 25591663Hasan 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.
- Results publicationWeli, 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.
- Results publicationAl-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.
- Results publicationRashad, 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heba Hamza, PhD study director
Cairo university, Professor of conservative dentistry
Mai Mamdouh, PhD study chair
Cairo university, lecturer of conservative dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cinnamon, Ginger and Chlorhexidine Gluconate in people with Dental Caries, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nadhel A Mohamed, Master (+201152267217, nadhel.mukred@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
viability count measurement (time frame: within two hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03061916, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2017.