Dental CariesNCT01569165
Effect of Water Rinsing After Topical Fluoride Application on Dental Plaque pH
A study testing cleansing teeth after topical fluoride therapy in people with Dental Caries, run by Mashhad University of Medical Sciences at 1 site in Iran.
Trial summary
The aim of this study was to determine whether rinsing with water or cleansing teeth after topical fluoride therapy affect the dental plaque pH. Read more about this study
- Who is it for?
- Ages 21 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- cleansing teeth after topical fluoride therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteIran
- Study dates
- Feb 2011to Nov 2011
- 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 21 to 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy people (Without any systemic disease)
- normal unstimulated salivary rate
Who cannot join
- Active dental caries
- taking any medication with any effect on saliva rate
- taking antibiotic (or antibacterial mouth rinses) during last 4 weeks
- usig fluoride mouth rinses during last 2 weeks.
Trial locations and contacts
1 site in 1 country.
Iran1 site
Dental School - Mashhad University of Medical Siences
Mashhad, Razavi Khorasan Province
About this study
Official title: Effect of Water Rinsing After APF Application on Dental Plaque Acidogenicity
The aim of this study was to determine whether rinsing with water or cleansing teeth after topical fluoride therapy affect the dental plaque pH.
- Conditions
- Dental Caries
- Being tested
- cleansing teeth after topical fluoride therapy
- Keywords
- Acidogenicity, Acidulated phosphate fluoride, dental plaque, water rinsing
- Medical subject headings
- Dental Caries, Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cleansing teeth after topical fluoride therapyProcedure or surgery
washing with water 0, 15 or 30 min after APF treatment or cleansing teeth with cotton roll immediately following APF treatment.
| Study group | Role | What they receive |
|---|---|---|
| washing after 30 min | Experimental | washing with water after 30 min following APF treatment Receives: Procedure: cleansing teeth after topical fluoride therapy |
| washing after 15 min | Experimental | washing with water after 15 min following APF treatment Receives: Procedure: cleansing teeth after topical fluoride therapy |
| immediately washing with water | Experimental | immediately washing with water after APF treatment Receives: Procedure: cleansing teeth after topical fluoride therapy |
| cleansing teeth with cotton roll | Experimental | cleansing teeth with cotton roll immediately following APF treatment Receives: Procedure: cleansing teeth after topical fluoride therapy |
| no fluoride therapy | No intervention | control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
dental plaque PH
Measured: the pH of 48-hour dental plaque was measured using plaque sampling method before (baseline pH) and after sucrose challenge at 5, 10,15,20,30 minutes
Secondary outcomes (2)
maximum pH drop
Measured: 5,10,15,20 and 30 min after sucrose chalenge
pH recovery time
time for returning to the baseline pH
Measured: within 30 min after sucrose challenge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2012 (estimated)
- Study startFeb 2011
- Primary completionOct 2011
- Study completionNov 2011
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.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mashhad University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatemeh Mazhari, Mashhad University of Medical Sciences
- Investigators
- fatemeh mazhari, Associate Professor, Principal investigator, Mashhad University of Medical Siences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01569165
- Sponsor's protocol ID
- 89629
- Status last verified
- Mar 2012
- First submitted
- 29 Mar 2012
- Last updated
- 3 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Water Rinsing After APF Application on Dental Plaque Acidogenicity
- ClinicalTrials.gov ID
- NCT01569165
- Acronym / sponsor ID
- 89629
- Conditions
- Dental Caries
- Keywords
- Acidogenicity, Acidulated phosphate fluoride, dental plaque, water rinsing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Mashhad University of Medical SciencesUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 3 Apr 2012 (estimated)
- 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.
The aim of this study was to determine whether rinsing with water or cleansing teeth after topical fluoride therapy affect the dental plaque pH.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| washing after 30 min | Experimental | Procedure: cleansing teeth after topical fluoride therapywashing with water after 30 min following APF treatment |
| washing after 15 min | Experimental | Procedure: cleansing teeth after topical fluoride therapywashing with water after 15 min following APF treatment |
| immediately washing with water | Experimental | Procedure: cleansing teeth after topical fluoride therapyimmediately washing with water after APF treatment |
| cleansing teeth with cotton roll | Experimental | Procedure: cleansing teeth after topical fluoride therapycleansing teeth with cotton roll immediately following APF treatment |
| no fluoride therapy | No intervention | –control group |
Who may qualify
- Ages
- 21 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- healthy people (Without any systemic disease)
- normal unstimulated salivary rate
Key exclusion criteria (4 listed)
- Active dental caries
- taking any medication with any effect on saliva rate
- taking antibiotic (or antibacterial mouth rinses) during last 4 weeks
- usig fluoride mouth rinses during last 2 weeks.
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 |
|---|---|---|
| cleansing teeth after topical fluoride therapywashing with water 0, 15 or 30 min after APF treatment or cleansing teeth with cotton roll immediately following APF treatment. | Procedure or surgery | cleansing teeth with cotton roll, immediately washing with water, washing after 15 min, washing after 30 min |
Primary outcome
dental plaque PH
Time frame: the pH of 48-hour dental plaque was measured using plaque sampling method before (baseline pH) and after sucrose challenge at 5, 10,15,20,30 minutes
2 secondary outcomes
maximum pH drop
Time frame: 5,10,15,20 and 30 min after sucrose chalenge
pH recovery time
Time frame: within 30 min after sucrose challenge
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 3 Apr 2012.
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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.
fatemeh mazhari, Associate Professor principal investigator
Mashhad University of Medical Siences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cleansing teeth after topical fluoride therapy in people with Dental Caries, run by Mashhad University of Medical Sciences at 1 site in Iran.
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 2 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: finished, as of the sponsor's last update on 3 Apr 2012. 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 Iran. 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?
dental plaque PH (time frame: the pH of 48-hour dental plaque was measured using plaque sampling method before (baseline pH) and after sucrose challenge at 5, 10,15,20,30 minutes). 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 3 Apr 2012.