Streptococcus MutansNCT04565912
Streptococcus Mutans Pathogenicity by Real-time Polymerase Chain Reaction (PCR) in High Caries Risk Patients
A study testing Sage extract mouthwash and Chlorohexidine based mouthwash in people with Streptococcus Mutans, run by Cairo University.
Trial summary
In patients with high caries risk, will the use of sage extract or chlorohexidine based mouthwashes have an effect on the percentage recovery of Streptococcus Mutans (SM) and its pathogenicity 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
- What is being tested?
- Sage extract mouthwash and Chlorohexidine based mouthwash
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- 6 Jul 2021to 1 Oct 2022
- 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
- patients will be recruited in this study, all volunteers participated will be medically free Age range 20-50
- Patients with high caries risk assessment 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)
- Not under antibiotic therapy either time of the study or up to the last month before the begging of the study
- Male or female patients.
Who cannot join
- patients with a compromised medical history.
- Patients with low caries risk assessment according to ADA caries risk assessment model.
- Patients with sever or active periodontal disease.
- Patients with a history of allergy to any of drugs or chemicals used in this study.
- Smoking patients
- Patients with abnormal salivary rate
- Pregnant female patients.
About this study
Official title: Efficacy of Sage Extract or Chlorohexidine Mouthwashes on Streptococcus Mutans Pathogenicity by Real-time Polymerase Chain Reaction (PCR) in High Caries Risk Patients : A Randomized Clinical Trial
In patients with high caries risk, will the use of sage extract or chlorohexidine based mouthwashes have an effect on the percentage recovery of Streptococcus Mutans (SM) and its pathogenicity detected by Real-Time Polymerase Chain Reaction (PCR) over one month follow up
Read the detailed description
The clinical study will be held in the clinic of conservative department, Faculty of Dentistry, Cairo University. The operator in charge will be Dina Fayez Diab. Patients will be examined and selected according to inclusion and exclusion criteria, the purpose and method of the study will be explained to the selected patients for participation in the study. In the first visit , ADA caries risk assessment model will be done. Participants will be divided in to two groups according to the tested mouthwashes.
All patients will be instructed not to have a 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 container held near the mouth. The containers will be properly labelled.
This study will be carried over one month , the saliva samples for each patients will be collected on the first dental visit. These samples will be sent to the laboratory for microbiological assessment. Patients will be provided with mouthwashes according to the tested groups and will be instructed to use it 2 times per day for 1 minute each time and no eating or drinking allowed for at least 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 the 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 laboratory for microbiological assessment. After completing the treatment for another 2 weeks , patients will come for the last dental visit to collect salivary samples which will be sent to laboratory for microbiological assessment.
- Conditions
- Streptococcus Mutans
- Being tested
- Sage extract mouthwash, Chlorohexidine based mouthwash
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sage extract mouthwashDrug
Also called Natural product mouthwash
Patients will be exposed to sage extract mouthwash and will be instructed to use 10 ml of sage extract mouthwash 2 times per day for 1 minute, such a regimen will be continued for one month.
Chlorohexidine based mouthwashDrug
Also called Synthetic mouthwash
Patients will be exposed to Chlorohexidine based mouthwash , and will be instructed to use 10 ml of 0.12% chlorohexidine based mouthwash 2 times per day for 1 minute, such a regimen will be continued for one month
| Study group | Role | What they receive |
|---|---|---|
| Sage extract mouthwash | Experimental | Natural product mouthwash Receives: Drug: Sage extract mouthwash |
| Chlorohexidine mouthwash | Active comparator | Synthetic mouthwash 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) 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 the 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 separation. The aqueous phase containing DNA will be transferred to clean eppendorf Real-Time Polymerase Chain Reaction: the PCR will be done in 20 ul reaction volume containing : DNA template, enzymes primer and nuclease- free water. The tubes containing the PCR mixture will be transferred to the cycler apparatus. The PCR products will be analyzed in agarose gel by electrophoresis, photographed and analyzed
Measured: 1 month
Total protein profile
Proteins can be separated according to their molecular weight by Sodium dodecyl sulphate poly acrylamide gel electrophoresis (SDS-PAGE)
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 posted25 Sep 2020
- Study start6 Jul 2021 (estimated)
- Primary completion1 Oct 2021 (estimated)
- Study completion1 Oct 2022 (estimated)
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 (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Fayez Shebl Diab, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04565912
- Sponsor's protocol ID
- 20788
- Status last verified
- Sep 2020
- First submitted
- 22 Sep 2020
- Last updated
- 26 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Sage Extract or Chlorohexidine Mouthwashes on Streptococcus Mutans Pathogenicity by Real-time Polymerase Chain Reaction (PCR) in High Caries Risk Patients : A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04565912
- Acronym / sponsor ID
- 20788
- Conditions
- Streptococcus Mutans
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 6 Jul 2021 (estimated)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 25 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 sage extract or chlorohexidine based mouthwashes have an effect on the percentage recovery of Streptococcus Mutans (SM) and its pathogenicity detected by Real-Time Polymerase Chain Reaction (PCR) over one month follow up
Detailed description
The clinical study will be held in the clinic of conservative department, Faculty of Dentistry, Cairo University. The operator in charge will be Dina Fayez Diab. Patients will be examined and selected according to inclusion and exclusion criteria, the purpose and method of the study will be explained to the selected patients for participation in the study. In the first visit , ADA caries risk assessment model will be done. Participants will be divided in to two groups according to the tested mouthwashes.
All patients will be instructed not to have a 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 container held near the mouth. The containers will be properly labelled.
This study will be carried over one month , the saliva samples for each patients will be collected on the first dental visit. These samples will be sent to the laboratory for microbiological assessment. Patients will be provided with mouthwashes according to the tested groups and will be instructed to use it 2 times per day for 1 minute each time and no eating or drinking allowed for at least 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 the 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 laboratory for microbiological assessment. After completing the treatment for another 2 weeks , patients will come for the last dental visit to collect salivary samples which will be sent to 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 |
|---|---|---|
| Sage extract mouthwash | Experimental | Drug: Sage extract mouthwashNatural product mouthwash |
| Chlorohexidine mouthwash | Active comparator | Drug: Chlorohexidine based mouthwashSynthetic mouthwash |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- patients will be recruited in this study, all volunteers participated will be medically free Age range 20-50
- Patients with high caries risk assessment 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)
- Not under antibiotic therapy either time of the study or up to the last month before the begging of the study
Key exclusion criteria (7 listed)
- patients with a compromised medical history.
- Patients with low caries risk assessment according to ADA caries risk assessment model.
- Patients with sever or active periodontal disease.
- Patients with a history of allergy to any of drugs or chemicals used in this study.
- Smoking patients
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 |
|---|---|---|
| Sage extract mouthwashAlso: Natural product mouthwashPatients will be exposed to sage extract mouthwash and will be instructed to use 10 ml of sage extract mouthwash 2 times per day for 1 minute, such a regimen will be continued for one month. | Drug | Sage extract mouthwash |
| Chlorohexidine based mouthwashAlso: Synthetic mouthwashPatients will be exposed to Chlorohexidine based mouthwash , and will be instructed to use 10 ml of 0.12% chlorohexidine based mouthwash 2 times per day for 1 minute, such a regimen will be continued for one month | Drug | Chlorohexidine mouthwash |
Primary outcome
Total bacterial count
Time frame: 1 month
Quantitative plating ( standard plate count or SPC) 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 the living organisms, not dead ones
2 secondary outcomes
Bacterial identification
Time frame: 1 month
Total protein profile
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2021.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Sage extract mouthwash and Chlorohexidine based mouthwash in people with Streptococcus Mutans, run by Cairo University.
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 7 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 26 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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 26 Jan 2021.