Dental CariesNCT03143023
Efficacy of Dentifrices Containing Arginine Versus Fluoride on Microbial Acid
A study testing arginine toothpaste and fluoride toothpaste in people with Dental Caries, run by Cairo University.
Trial summary
This study will be conducted to evaluate the effect of arginine versus fluoride containing toothpaste on neutralization of microbial acid produced by Cariogenic bacteria in adult population using chair side assessment method. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- arginine toothpaste and fluoride toothpaste
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- Jun 2017to Feb 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants should be over 18 years of age.
- 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 arginine, or oral care product or their ingredient.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy of Dentifrices Containing Arginine Versus Fluoride on Microbial Acid Using Chair Side(Potential of Hydrogen) pH Meter Assessment Method in Adult Population: Randomized Clinical Trial
This study will be conducted to evaluate the effect of arginine versus fluoride containing toothpaste on neutralization of microbial acid produced by Cariogenic bacteria in adult population using chair side assessment method.
Read the detailed description
.28 volunteer participants will be assigned in this study. Participants will be randomly divided into two groups(n=14) according to type of toothpaste D where groups D1 patient will use arginine containing toothpaste while groups D2 the patient will used the fluoride toothpaste with a number of 14 patients in each group. The pH will be evaluated according to time in relation to the brushing with toothpaste (T) where (T0) represent salivary pH before brushing with toothpaste , (T1) represent salivary pH 10 minutes after brushing with toothpaste at fixed time of the day.
- Conditions
- Dental Caries
- Being tested
- arginine toothpaste, fluoride toothpaste
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arginine toothpasteDrug
acid neutralizer toothpaste
fluoride toothpasteDrug
bactericidal toothpaste
| Study group | Role | What they receive |
|---|---|---|
| arginine toothpaste | Experimental | Not described Receives: Drug: arginine toothpaste |
| fluoride toothpaste | Active comparator | Not described Receives: Drug: fluoride toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
salivary pH
Salivary pH will be determined by use of a digital pH meter .All salivary pH values will be taken immediately following salivary collection at chairside. The salivary pH values measured before usage of toothpaste termed "resting pH," while the salivary pH values measured after usage of toothpaste termed "terminal pH.
Measured: 10 minutes after intervention and control
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2017
- Study startJun 2017 (estimated)
- Primary completionDec 2017 (estimated)
- Study completionFeb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Yehia, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03143023
- Sponsor's protocol ID
- CEBC-CU-2017-04-18
- Status last verified
- May 2017
- First submitted
- 4 May 2017
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Dentifrices Containing Arginine Versus Fluoride on Microbial Acid Using Chair Side(Potential of Hydrogen) pH Meter Assessment Method in Adult Population: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03143023
- Acronym / sponsor ID
- CEBC-CU-2017-04-18
- Conditions
- Dental Caries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jun 2017 (estimated)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 8 May 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 arginine versus fluoride containing toothpaste on neutralization of microbial acid produced by Cariogenic bacteria in adult population using chair side assessment method.
Detailed description
.28 volunteer participants will be assigned in this study. Participants will be randomly divided into two groups(n=14) according to type of toothpaste D where groups D1 patient will use arginine containing toothpaste while groups D2 the patient will used the fluoride toothpaste with a number of 14 patients in each group. The pH will be evaluated according to time in relation to the brushing with toothpaste (T) where (T0) represent salivary pH before brushing with toothpaste , (T1) represent salivary pH 10 minutes after brushing with toothpaste at fixed time of the day.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| arginine toothpaste | Experimental | Drug: arginine toothpaste |
| fluoride toothpaste | Active comparator | Drug: fluoride toothpaste |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participants should be over 18 years of age.
- 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 arginine, 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 |
|---|---|---|
| arginine toothpasteacid neutralizer toothpaste | Drug | arginine toothpaste |
| fluoride toothpastebactericidal toothpaste | Drug | fluoride toothpaste |
Primary outcome
salivary pH
Time frame: 10 minutes after intervention and control
Salivary pH will be determined by use of a digital pH meter .All salivary pH values will be taken immediately following salivary collection at chairside. The salivary pH values measured before usage of toothpaste termed "resting pH," while the salivary pH values measured after usage of toothpaste termed "terminal pH.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing arginine toothpaste and fluoride toothpaste in people with Dental Caries, 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 4 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 9 May 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?
Contact laura yehia zanati, master (01204470007, laura_lola92@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
salivary pH (time frame: 10 minutes after intervention and control). 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 9 May 2017.