Risk ReductionNCT03222960
Improving Caries Risk Using Propolis-containing Versus Fluoride-containing Toothpastes in High Caries Risk Patients
A study testing propolis-containing toothpaste and Fluoride-containing toothpaste in people with Risk Reduction, run by Cairo University.
Trial summary
This study will be conducted to evaluate the effect of Propolis-containing toothpaste in comparison to Fluoride-containing Toothpaste by caries risk assessment in high caries risk patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Risk Reduction
- What is being tested?
- propolis-containing toothpaste and Fluoride-containing toothpaste
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Oct 2017to Apr 2018
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants should be over 18 years of age.
- Participants should be high caries risk.
- Systematically healthy.
- Not taking any medication interfering with saliva secretion.
- Participants who signed informed consent.
Who cannot join
- Participants with a compromised medical history.
- Participants under systemic disease treatment, with antibiotic, steroid or any medication known to cause dry mouth.
- Severe or active periodontal disease.
- History of allergies or other adverse reactions to propolis, or oral care product or their ingredient.
About this study
Official title: Improving Caries Risk Using Propolis-containing Versus Fluoride-containing Toothpastes in High Caries Risk Patients: Randomized Clinical Trial
This study will be conducted to evaluate the effect of Propolis-containing toothpaste in comparison to Fluoride-containing Toothpaste by caries risk assessment in high caries risk patients.
Read the detailed description
A total of 40 patients will be assigned in this study. Patients will be randomly divided into two groups according to type of Toothpaste (A) where group A1 patients will use propolis containing toothpaste twice daily while group A2 patients will use fluoride containing toothpaste twice daily as control with 20 patients in each group. Each group will be further divided into three groups according to caries risk assessment times (T) where T0 represents caries risk assessment of patients before application of propolis and fluoride toothpastes and T1 represents caries risk assessment of patients after three months of application of propolis and fluoride toothpastes, T2 represents caries risk assessment of patients after six months of application of propolis and fluoride toothpastes.
Both Propolis containing toothpaste and fluoride containing toothpaste will be placed in concealed tubes. The tubes will completely wrapped by plain white tape to conceal the formulation of toothpaste. Participants are given the tubes of toothpaste and soft brush with a coloured mark at 2 cm length of the bristle surface. The technique can be summarised in four steps:
- 2 cm of the toothpaste will be squeezed over the wet toothbrush bristles
- The upper and lower teeth will be brushed for 2 min;
- After brushing, the remaining toothpaste foam and saliva "slurry" will be swished around the dentition with active movements of the cheeks, lips and tongue, forcing the slurry in between the teeth for about 20 seconds before expectorating the slurry
- No post-brushing water rinsing will be carried out All these steps will be presented in a reminder card and all patients will put a tick mark for every step.
- Conditions
- Risk Reduction
- Being tested
- propolis-containing toothpaste, Fluoride-containing toothpaste
- Medical subject headings
- Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propolis-containing toothpasteDrug
Also called Red seal propolis toothpaste
participants will use propolis-containing toothpaste for 6 months
Fluoride-containing toothpasteDrug
Also called colgate
participants will use Fluoride-containing toothpaste for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Propolis-containing toothpaste | Experimental | Assessment of caries risk for participants using Propolis-containing toothpaste before the treatment , after 3 months and 6 months follow up. Receives: Drug: propolis-containing toothpaste |
| Fluoride-containing toothpaste | Experimental | Assessment of caries risk for participants using Fluoride-containing toothpaste before the treatment , after 3 months and 6 months follow up. Receives: Drug: Fluoride-containing toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improving caries risk
caries risk assessment
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2017
- Study startOct 2017 (estimated)
- Primary completionApr 2018 (estimated)
- Study completionApr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Risk ReductionStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Fawzy Meselhy Maarek, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03222960
- Sponsor's protocol ID
- CEBC-CU-2017-07-26
- Status last verified
- Jul 2017
- First submitted
- 18 Jul 2017
- Last updated
- 25 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Caries Risk Using Propolis-containing Versus Fluoride-containing Toothpastes in High Caries Risk Patients: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03222960
- Acronym / sponsor ID
- CEBC-CU-2017-07-26
- Conditions
- Risk Reduction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Oct 2017 (estimated)
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 19 Jul 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.
This study will be conducted to evaluate the effect of Propolis-containing toothpaste in comparison to Fluoride-containing Toothpaste by caries risk assessment in high caries risk patients.
Detailed description
A total of 40 patients will be assigned in this study. Patients will be randomly divided into two groups according to type of Toothpaste (A) where group A1 patients will use propolis containing toothpaste twice daily while group A2 patients will use fluoride containing toothpaste twice daily as control with 20 patients in each group. Each group will be further divided into three groups according to caries risk assessment times (T) where T0 represents caries risk assessment of patients before application of propolis and fluoride toothpastes and T1 represents caries risk assessment of patients after three months of application of propolis and fluoride toothpastes, T2 represents caries risk assessment of patients after six months of application of propolis and fluoride toothpastes.
Both Propolis containing toothpaste and fluoride containing toothpaste will be placed in concealed tubes. The tubes will completely wrapped by plain white tape to conceal the formulation of toothpaste. Participants are given the tubes of toothpaste and soft brush with a coloured mark at 2 cm length of the bristle surface. The technique can be summarised in four steps:
- 2 cm of the toothpaste will be squeezed over the wet toothbrush bristles
- The upper and lower teeth will be brushed for 2 min;
- After brushing, the remaining toothpaste foam and saliva "slurry" will be swished around the dentition with active movements of the cheeks, lips and tongue, forcing the slurry in between the teeth for about 20 seconds before expectorating the slurry
- No post-brushing water rinsing will be carried out All these steps will be presented in a reminder card and all patients will put a tick mark for every step.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propolis-containing toothpaste | Experimental | Drug: propolis-containing toothpasteAssessment of caries risk for participants using Propolis-containing toothpaste before the treatment , after 3 months and 6 months follow up. |
| Fluoride-containing toothpaste | Experimental | Drug: Fluoride-containing toothpasteAssessment of caries risk for participants using Fluoride-containing toothpaste before the treatment , after 3 months and 6 months follow up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants should be over 18 years of age.
- Participants should be high caries risk.
- Systematically healthy.
- Not taking any medication interfering with saliva secretion.
- Participants who signed informed consent.
Key exclusion criteria (4 listed)
- Participants with a compromised medical history.
- Participants under systemic disease treatment, with antibiotic, steroid or any medication known to cause dry mouth.
- Severe or active periodontal disease.
- History of allergies or other adverse reactions to propolis, or oral care product or their ingredient.
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 |
|---|---|---|
| propolis-containing toothpasteAlso: Red seal propolis toothpasteparticipants will use propolis-containing toothpaste for 6 months | Drug | Propolis-containing toothpaste |
| Fluoride-containing toothpasteAlso: colgateparticipants will use Fluoride-containing toothpaste for 6 months | Drug | Fluoride-containing toothpaste |
Primary outcome
Improving caries risk
Time frame: 6 months
caries risk assessment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2017.
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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 propolis-containing toothpaste and Fluoride-containing toothpaste in people with Risk Reduction, 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 5 inclusion and 4 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 25 Jul 2017. 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?
Improving caries risk (time frame: 6 months). 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 25 Jul 2017.