Streptococcus MutansNCT04566120
Streptococcus Mutans Cariogenicity by Real-time PCR in High Caries Risk Patients
A study testing cinnamon extract mouthwash and chlorohexidine based mouthwash in people with Streptococcus Mutans and High Caries Risk Patients, run by Cairo University at 1 site in Egypt.
Trial summary
In patients with high caries risk, will the use of cinnamon extract or chlorohexidine based mouthwashes have an effect on the percentage of recovery and cariogenicity of Streptococcus mutans (SM) detected by real-time Polymerase Chain Reaction (PCR) over one month follow up Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Streptococcus Mutans, High Caries Risk Patients
- What is being tested?
- cinnamon extract mouthwash and chlorohexidine based mouthwash
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2021to 1 Feb 2023
- Phase
- Interventional
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults will be recruited in this study, all the volunteers participated in this experiment will be healthy looking with free medical history.
- Age range 20-50 years
- High caries risk patients according to ADA caries risk assessment model.
- High plaque index (>score 2)
- Non-smoking patients.
- Patients with normal salivary rate (0.3-0.4 ml/min).
Who cannot join
- Patients with a compromised medical history.
- Participants with low caries risk.
- Patients with severe or active periodontal disease.
- Participants with a history of allergy to any of the drugs or chemicals used in the study.
- Patients on any antibiotics during the past month
- Smoking patients.
- Patients with abnormal salivary rate.
- Pregnant female patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Detection of Streptococcus Mutans Cariogenicity by Real-time PCR in High Caries Risk Patients Using Cinnamon Extract or Chlorohexidine Mouthwashes: A Randomized Clinical Trial
In patients with high caries risk, will the use of cinnamon extract or chlorohexidine based mouthwashes have an effect on the percentage of recovery and cariogenicity of Streptococcus mutans (SM) detected by real-time Polymerase Chain Reaction (PCR) over one month follow up
Read the detailed description
This clinical study will be held in the clinic of conservative dentistry department, Faculty of Dentistry, Cairo University. The operator in charge will be Mostafa Mahmoud El-Ghazali. Patients will be examined and selected according to inclusion and exclusion criteria, the purpose and method of the study will be explaned to the selected patients, written informed consent will be obtained from the patients for participation in the study. In the first visit, ADA caries risk assessment model will be done. Participants will be divided into two groups according to the tested mouthwashes.
All patients will be instructed not to have breakfast and to refrain any oral hygiene measures on the day of sample collection to avoid the influence of food consumption and contamination on the composition of saliva. The patient will sit in an erect position on the dental chair and will be given paraffin block to chew. The stimulated saliva will be collected after 2 minutes of paraffin chewing in sterile containers held near the mouth. The containers will be properly labeled. The study will be carried over a period of one month, the saliva samples for each patient will be collected on the first dental visit. These samples will be then sent to the laboratory for microbiological assessment. Patients will be provided with mouthwashes according to the tested groups and they will be instructed to use it 2 times per day for 1 minute each time and no eating or drinking permitted for a minimum of 30 minutes post rinsing. Each patient will be given the same instructions with respect to oral hygiene measures. They will be advised to continue on same diet and will be instructed not to change their dietary habits. Patients will come after 2 weeks for salivary samples collection and samples will be sent to the laboratory for microbiological assessment. After treatment continuity for another 2 weeks, patients will come for the last visit to collect the salivary samples which will be sent to the laboratory for microbiological assessment.
- Conditions
- Streptococcus Mutans, High Caries Risk Patients
- Being tested
- cinnamon extract mouthwash, chlorohexidine based mouthwash
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cinnamon extract mouthwashDrug
Also called Natural Product Mouthwash
cinnamon extract mouthwash
chlorohexidine based mouthwashDrug
Also called Synthetic Mouthwash
chlorohexidine based mouthwash
| Study group | Role | What they receive |
|---|---|---|
| Cinnamon extract mouthwash | Experimental | Participants will be exposed to cinnamon extract mouthwash and will be instructed to use 10 ml of cinnamon extract mouthwash 2 times per day for 1 minute; such a regimen will be continued for one month. Receives: Drug: cinnamon extract mouthwash |
| Chlorohexidine based mouthwash | Active comparator | Participants will be exposed to chlorohexidine based mouthwash. and will be instructed to use 10 ml of 0.12% chlorhexidine based mouthwash 2 times per day for 1 minute; such a regimen will be continued for one month. Receives: Drug: chlorohexidine based mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total bacterial count
quantitative plating (standard plate count or SPC)n will be used to determine the number of bacteria in a culture sample. SPC reveals information on viable organisms only; bacteria colonies that are seen in the plates after incubation represent only living organisms, not dead ones.
Measured: 1 month
Secondary outcomes (2)
Bacterial Identification
Total extraction of DNA: Total plasmid DNA will be prepared. The solution will be centrifuged and then left at room temperature for few minutes for the phase separations. The aqueous phase containing DNA will be transferred to clean eppendorf.
PCR Polymerase chain reaction: The PCR will be performed in 25µl reaction volume containing: DNA template, enzymes, primer and nuclease-free water. The tubes containing the PCR mixture will be transferred to the thermal cycler apparatus. The PCR products will be analyzed in agarose gel by electrophoresis, photographed and analyzed.
Measured: 1 month
Glycosyltransferase B & D gene expression.
The real time PCR for relative quantification of target bacterial genes will be performed in a total volume of 20 μL using 10 µL SYBR® Premix Ex TaqTM master mix, 0.4 µL of each forward and reverse primer, 0.08 µL diluted ROX, and 2 µL of DNA template
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2020
- Study start1 Jan 2021
- Primary completion1 Dec 2022
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Streptococcus MutansStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Mahmoud Mohamed Kamel El-Ghazali, Cairo University
- Investigators
- Mostafa El-Ghazali, Principal investigator, Assistant Lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04566120
- Sponsor's protocol ID
- oper131
- Status last verified
- Dec 2023
- First submitted
- 22 Sep 2020
- Last updated
- 13 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Streptococcus Mutans Cariogenicity by Real-time PCR in High Caries Risk Patients Using Cinnamon Extract or Chlorohexidine Mouthwashes: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04566120
- Acronym / sponsor ID
- oper131
- Conditions
- Streptococcus Mutans, High Caries Risk Patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 28 Sep 2020 (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.
In patients with high caries risk, will the use of cinnamon extract or chlorohexidine based mouthwashes have an effect on the percentage of recovery and cariogenicity of Streptococcus mutans (SM) detected by real-time Polymerase Chain Reaction (PCR) over one month follow up
Detailed description
This clinical study will be held in the clinic of conservative dentistry department, Faculty of Dentistry, Cairo University. The operator in charge will be Mostafa Mahmoud El-Ghazali. Patients will be examined and selected according to inclusion and exclusion criteria, the purpose and method of the study will be explaned to the selected patients, written informed consent will be obtained from the patients for participation in the study. In the first visit, ADA caries risk assessment model will be done. Participants will be divided into two groups according to the tested mouthwashes.
All patients will be instructed not to have breakfast and to refrain any oral hygiene measures on the day of sample collection to avoid the influence of food consumption and contamination on the composition of saliva. The patient will sit in an erect position on the dental chair and will be given paraffin block to chew. The stimulated saliva will be collected after 2 minutes of paraffin chewing in sterile containers held near the mouth. The containers will be properly labeled. The study will be carried over a period of one month, the saliva samples for each patient will be collected on the first dental visit. These samples will be then sent to the laboratory for microbiological assessment. Patients will be provided with mouthwashes according to the tested groups and they will be instructed to use it 2 times per day for 1 minute each time and no eating or drinking permitted for a minimum of 30 minutes post rinsing. Each patient will be given the same instructions with respect to oral hygiene measures. They will be advised to continue on same diet and will be instructed not to change their dietary habits. Patients will come after 2 weeks for salivary samples collection and samples will be sent to the laboratory for microbiological assessment. After treatment continuity for another 2 weeks, patients will come for the last visit to collect the salivary samples which will be sent to the laboratory for microbiological assessment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cinnamon extract mouthwash | Experimental | Drug: cinnamon extract mouthwashParticipants will be exposed to cinnamon extract mouthwash and will be instructed to use 10 ml of cinnamon extract mouthwash 2 times per day for 1 minute; such a regimen will be continued for one month. |
| Chlorohexidine based mouthwash | Active comparator | Drug: chlorohexidine based mouthwashParticipants will be exposed to chlorohexidine based mouthwash. and will be instructed to use 10 ml of 0.12% chlorhexidine based mouthwash 2 times per day for 1 minute; such a regimen will be continued for one month. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Adults will be recruited in this study, all the volunteers participated in this experiment will be healthy looking with free medical history.
- Age range 20-50 years
- High caries risk patients according to ADA caries risk assessment model.
- High plaque index (>score 2)
- Non-smoking patients.
Key exclusion criteria (8 listed)
- Patients with a compromised medical history.
- Participants with low caries risk.
- Patients with severe or active periodontal disease.
- Participants with a history of allergy to any of the drugs or chemicals used in the study.
- Patients on any antibiotics during the past month
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 |
|---|---|---|
| cinnamon extract mouthwashAlso: Natural Product Mouthwashcinnamon extract mouthwash | Drug | Cinnamon extract mouthwash |
| chlorohexidine based mouthwashAlso: Synthetic Mouthwashchlorohexidine based mouthwash | Drug | Chlorohexidine based mouthwash |
Primary outcome
Total bacterial count
Time frame: 1 month
quantitative plating (standard plate count or SPC)n will be used to determine the number of bacteria in a culture sample. SPC reveals information on viable organisms only; bacteria colonies that are seen in the plates after incubation represent only living organisms, not dead ones.
2 secondary outcomes
Bacterial Identification
Time frame: 1 month
Glycosyltransferase B & D gene expression.
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
- Individual participant dataSharing planned: Yes. 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.
Mostafa El-Ghazali principal investigator
Assistant Lecturer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cinnamon extract mouthwash and chlorohexidine based mouthwash in people with Streptococcus Mutans and High Caries Risk Patients, 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 6 inclusion and 8 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: finished, as of the sponsor's last update on 13 Dec 2023. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total bacterial count (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Dec 2023.