Decay, DentalNCT03623048
Effect of Natural Antibacterial Mouthwash on Taste, Salivary pH and Bacteria in High Caries Risk pt
A study testing chlorhexidine, saline and Propolis extract in people with Decay, Dental, run by Cairo University.
Trial summary
Evaluate the effect of propolis extract mouthwash and pomegranate extract mouthwash on taste alteration, salivary pH and antibacterial activity against streptococcus mutans in high caries risk patients. Read more about this study
- Who is it for?
- Ages 17 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Decay, Dental
- What is being tested?
- chlorhexidine, saline and Propolis extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Mar 2019to Apr 2019
- 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 17 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- High caries risk patients defined according to American Dental Association (ADA)
- Systematically healthy
- Not taking any medication interfering with saliva secretion
- Subjects who signed informed consent
- Age range from 17-50 years
Who cannot join
- Subjects suffering from any medical or systematic disease
- Smokers
- Pregnant females
- Allergy to any of the mouthwash ingredients
- Patients older than 50 years
About this study
Official title: Effect of Propolis and Pomegranate Extract Mouthwash on Taste Alteration, Salivary pH and Antibacterial Activity in High Caries Risk Patients
Evaluate the effect of propolis extract mouthwash and pomegranate extract mouthwash on taste alteration, salivary pH and antibacterial activity against streptococcus mutans in high caries risk patients.
Read the detailed description
This study will be carried out to evaluate and compare the effect of propolis extract mouthwash and pomegranate (botanical name: Punica granatum) extract mouthwash on taste alteration, salivary pH and antibacterial activity against streptococcus mutans in high caries risk patients.
Thats by taking unstimulated saliva samples at the morning before using the mouthwash, then taking another one after using the mouthwash and finally after 7 days, to make a bacterial culture and measure the salivary pH by a digital pH meter and evaluate taste changes by a questionnaire.
- Conditions
- Decay, Dental
- Being tested
- chlorhexidine, saline, Propolis extract, pomegranate extract
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chlorhexidineOther
Also called hexitol
antibacterial and anti-inflammatory mouthwash
salineOther
Also called NaCl solution
anti-inflammatory cleansing mouthwash
Propolis extractOther
antibacterial mouthwash
pomegranate extractOther
antibacterial mouthwash
| Study group | Role | What they receive |
|---|---|---|
| Propolis extract | Experimental | intervention Receives: Other: Propolis extract |
| Pomegranate extract | Experimental | intervention Receives: Other: pomegranate extract |
| Chlorhexidine | Active comparator | comparator Receives: Other: chlorhexidine |
| Saline | Placebo comparator | comparator Receives: Other: saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Taste alteration
taste changes will be measured by a questionnaire
Measured: One week
Secondary outcomes (1)
Salivary pH
salivary pH will be measured by digital pH meter
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study startMar 2019 (estimated)
- Primary completionApr 2019 (estimated)
- Study completionApr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Decay, DentalStudies 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Randa Abdelrahman, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03623048
- Sponsor's protocol ID
- CEBD-CU-2018-08-04
- Status last verified
- Sep 2018
- First submitted
- 7 Aug 2018
- Last updated
- 11 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Propolis and Pomegranate Extract Mouthwash on Taste Alteration, Salivary pH and Antibacterial Activity in High Caries Risk Patients
- ClinicalTrials.gov ID
- NCT03623048
- Acronym / sponsor ID
- CEBD-CU-2018-08-04
- Conditions
- Decay, Dental
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Mar 2019 (estimated)
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 9 Aug 2018 (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.
Evaluate the effect of propolis extract mouthwash and pomegranate extract mouthwash on taste alteration, salivary pH and antibacterial activity against streptococcus mutans in high caries risk patients.
Detailed description
This study will be carried out to evaluate and compare the effect of propolis extract mouthwash and pomegranate (botanical name: Punica granatum) extract mouthwash on taste alteration, salivary pH and antibacterial activity against streptococcus mutans in high caries risk patients.
Thats by taking unstimulated saliva samples at the morning before using the mouthwash, then taking another one after using the mouthwash and finally after 7 days, to make a bacterial culture and measure the salivary pH by a digital pH meter and evaluate taste changes by a questionnaire.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Propolis extract | Experimental | Other: Propolis extractintervention |
| Pomegranate extract | Experimental | Other: pomegranate extractintervention |
| Chlorhexidine | Active comparator | Other: chlorhexidinecomparator |
| Saline | Placebo comparator | Other: salinecomparator |
Who may qualify
- Ages
- 17 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- High caries risk patients defined according to American Dental Association (ADA)
- Systematically healthy
- Not taking any medication interfering with saliva secretion
- Subjects who signed informed consent
- Age range from 17-50 years
Key exclusion criteria (5 listed)
- Subjects suffering from any medical or systematic disease
- Smokers
- Pregnant females
- Allergy to any of the mouthwash ingredients
- Patients older than 50 years
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 |
|---|---|---|
| chlorhexidineAlso: hexitolantibacterial and anti-inflammatory mouthwash | Other | Chlorhexidine |
| salineAlso: NaCl solutionanti-inflammatory cleansing mouthwash | Other | Saline |
| Propolis extractantibacterial mouthwash | Other | Propolis extract |
| pomegranate extractantibacterial mouthwash | Other | Pomegranate extract |
Primary outcome
Taste alteration
Time frame: One week
taste changes will be measured by a questionnaire
1 secondary outcome
Salivary pH
Time frame: one week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2018.
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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 chlorhexidine, saline and Propolis extract in people with Decay, Dental, 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 5 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 11 Sep 2018. 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. Some participants in this study may receive a placebo. 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?
Taste alteration (time frame: One week). 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 11 Sep 2018.