Dental Devices, Home CareNCT02971514
Comparative Efficacy of Dental Flossing Before or After Tooth Brushing on Interproximal Plaque Reduction and Fluoride Retention in That Area
A study testing Flossing before Brushing and Brushing before Flossing in people with Dental Devices, Home Care, run by Mashhad University of Medical Sciences at 1 site in Iran.
Trial summary
This randomized controlled crossover trial conducted on 25 dental students. in the preliminary session each volunteer was given a toothbrush(Trisa, soft, Switzerland) and toothpaste(Pooneh, Iran) and Dental Floss( Mina, Iran)to use during the study, and they were instructed the proper techniques of brushing and… Read more about this study
- Who is it for?
- Ages 20 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Devices, Home Care
- What is being tested?
- Flossing before Brushing and Brushing before Flossing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteIran
- Study dates
- May 2014to Apr 2015
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Dental students with 16 teeth in each jaw who had Normal salivary volume No active caries No medicine which could be affect salivary secretion No fluoride consumption in the last two weeks No Antibiotic consumption in the last 4 weeks
Who cannot join
- Any systemic diseases Periodontal diseases Crowding
Trial locations and contacts
1 site in 1 country.
About this study
This randomized controlled crossover trial conducted on 25 dental students. in the preliminary session each volunteer was given a toothbrush(Trisa, soft, Switzerland) and toothpaste(Pooneh, Iran) and Dental Floss( Mina, Iran)to use during the study, and they were instructed the proper techniques of brushing and flossing.The study was performed in two treatment sessions and a 48 hour washout period. They passed through the sessions in a randomized sequence. After prophylaxis with rubber cup, they were asked to discontinue all oral hygiene for 24 hour. At the first session , they flossed first followed by brushing (floss-brush group) and at the other session they used dental floss after brushing (brush-floss group) . At each session, before and after brushing and flossing , Dental plaque reduction was assessed using Rustogi Modified Navi Plaque Index. Interdental plaque was collected for measuring fluoride. Differences between the two groups were analyzed with mixed model test.
- Conditions
- Dental Devices, Home Care
- Being tested
- Flossing before Brushing, Brushing before Flossing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flossing before BrushingBehavioural
Brushing before FlossingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Floss-Brush group | Experimental | The participants flossed first followed by brushing Receives: Behavioral: Flossing before Brushing |
| Brush-Floss group | Active comparator | They used dental floss after brushing Receives: Behavioral: Brushing before Flossing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dental plaque reduction
Dental plaque assessed using a scale known as: "Rustogi Modified Navy Plaque Index"
Measured: immediately Before brushing/ flossing and immediately after these procedures
Secondary outcomes (1)
fluoride concentration in Interdental plaque
fluoride concentration measured using ppm scale (microgram/milliliter)
Measured: Immediately after toothbrushing /flossing interdental plaque was collected for fluoride measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2016 (estimated)
- Study startMay 2014
- Primary completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental Devices, Home CareStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02971514
- Sponsor's protocol ID
- 920200
- Status last verified
- Nov 2016
- First submitted
- 11 Nov 2016
- Last updated
- 23 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mazhari F, Boskabady M, Moeintaghavi A, Habibi A. The effect of toothbrushing and flossing sequence on interdental plaque reduction and fluoride retention: A randomized controlled clinical trial. J Periodontol. 2018 Jul;89(7):824-832. doi: 10.1002/JPER.17-0149. Epub 2018 Jul 20.
PubMed 29741239
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy of Dental Flossing Before or After Tooth Brushing on Interproximal Plaque Reduction and Fluoride Retention in That Area
- ClinicalTrials.gov ID
- NCT02971514
- Acronym / sponsor ID
- 920200
- Conditions
- Dental Devices, Home Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Mashhad University of Medical SciencesUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Apr 2015 (actual)
- First posted
- 23 Nov 2016 (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.
This randomized controlled crossover trial conducted on 25 dental students. in the preliminary session each volunteer was given a toothbrush(Trisa, soft, Switzerland) and toothpaste(Pooneh, Iran) and Dental Floss( Mina, Iran)to use during the study, and they were instructed the proper techniques of brushing and flossing.The study was performed in two treatment sessions and a 48 hour washout period. They passed through the sessions in a randomized sequence. After prophylaxis with rubber cup, they were asked to discontinue all oral hygiene for 24 hour. At the first session , they flossed first followed by brushing (floss-brush group) and at the other session they used dental floss after brushing (brush-floss group) . At each session, before and after brushing and flossing , Dental plaque reduction was assessed using Rustogi Modified Navi Plaque Index. Interdental plaque was collected for measuring fluoride. Differences between the two groups were analyzed with mixed model test.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Floss-Brush group | Experimental | Behavioral: Flossing before BrushingThe participants flossed first followed by brushing |
| Brush-Floss group | Active comparator | Behavioral: Brushing before FlossingThey used dental floss after brushing |
Who may qualify
- Ages
- 20 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Dental students with 16 teeth in each jaw who had Normal salivary volume No active caries No medicine which could be affect salivary secretion No fluoride consumption in the last two weeks No Antibiotic consumption in the last 4 weeks
Key exclusion criteria (1 listed)
- Any systemic diseases Periodontal diseases Crowding
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 |
|---|---|---|
| Flossing before Brushing | Behavioural | Floss-Brush group |
| Brushing before Flossing | Behavioural | Brush-Floss group |
Primary outcome
Dental plaque reduction
Time frame: immediately Before brushing/ flossing and immediately after these procedures
Dental plaque assessed using a scale known as: "Rustogi Modified Navy Plaque Index"
1 secondary outcome
fluoride concentration in Interdental plaque
Time frame: Immediately after toothbrushing /flossing interdental plaque was collected for fluoride measurement
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 23 Nov 2016.
- Derived from this study: PubMed 29741239Mazhari F, Boskabady M, Moeintaghavi A, Habibi A. The effect of toothbrushing and flossing sequence on interdental plaque reduction and fluoride retention: A randomized controlled clinical trial. J Periodontol. 2018 Jul;89(7):824-832. doi: 10.1002/JPER.17-0149. Epub 2018 Jul 20.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flossing before Brushing and Brushing before Flossing in people with Dental Devices, Home Care, 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 1 inclusion and 1 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 23 Nov 2016. 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 reduction (time frame: immediately Before brushing/ flossing and immediately after these procedures). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02971514, which also lists 1 linked publication.
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 23 Nov 2016.