- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02971514
Comparative Efficacy of Dental Flossing Before or After Tooth Brushing on Interproximal Plaque Reduction and Fluoride Retention in That Area
November 19, 2016 updated by: Fatemeh Mazhari, Mashhad University of Medical Sciences
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
25
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Khorasan Razavi
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Mashhad, Khorasan Razavi, Iran, Islamic Republic of, 91735-984
- Amir Moeintaghavi
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 25 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Any systemic diseases Periodontal diseases Crowding
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Floss-Brush group
The participants flossed first followed by brushing
|
|
|
Active Comparator: Brush-Floss group
They used dental floss after brushing
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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"
|
immediately Before brushing/ flossing and immediately after these procedures
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
fluoride concentration in Interdental plaque
Time Frame: Immediately after toothbrushing /flossing interdental plaque was collected for fluoride measurement
|
fluoride concentration measured using ppm scale (microgram/milliliter)
|
Immediately after toothbrushing /flossing interdental plaque was collected for fluoride measurement
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2014
Primary Completion (Actual)
April 1, 2015
Study Registration Dates
First Submitted
November 11, 2016
First Submitted That Met QC Criteria
November 19, 2016
First Posted (Estimate)
November 23, 2016
Study Record Updates
Last Update Posted (Estimate)
November 23, 2016
Last Update Submitted That Met QC Criteria
November 19, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- 920200
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.