Back to resultsEffect of Water Rinsing After Topical Fluoride Application on Dental Plaque pH
Primary Purpose
Dental Caries
Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
cleansing teeth after topical fluoride therapy
Sponsored by
About this trial
This is an interventional prevention trial for Dental Caries focused on measuring Acidogenicity, Acidulated phosphate fluoride, dental plaque, water rinsing
Eligibility Criteria
Inclusion Criteria:
- healthy people (Without any systemic disease)
- normal unstimulated salivary rate
Exclusion Criteria:
- 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.
Sites / Locations
- Dental School - Mashhad University of Medical Siences
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
No Intervention
Arm Label
washing after 30 min
washing after 15 min
immediately washing with water
cleansing teeth with cotton roll
no fluoride therapy
Arm Description
washing with water after 30 min following APF treatment
washing with water after 15 min following APF treatment
immediately washing with water after APF treatment
cleansing teeth with cotton roll immediately following APF treatment
control group
Outcomes
Primary Outcome Measures
dental plaque PH
Secondary Outcome Measures
maximum pH drop
pH recovery time
time for returning to the baseline pH
Full Information
NCT ID
NCT01569165
First Posted
March 29, 2012
Last Updated
March 30, 2012
Sponsor
Mashhad University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01569165
Brief Title
Effect of Water Rinsing After Topical Fluoride Application on Dental Plaque pH
Official Title
Effect of Water Rinsing After APF Application on Dental Plaque Acidogenicity
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
November 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mashhad University of Medical Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
Acidogenicity, Acidulated phosphate fluoride, dental plaque, water rinsing
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
washing after 30 min
Arm Type
Experimental
Arm Description
washing with water after 30 min following APF treatment
Arm Title
washing after 15 min
Arm Type
Experimental
Arm Description
washing with water after 15 min following APF treatment
Arm Title
immediately washing with water
Arm Type
Experimental
Arm Description
immediately washing with water after APF treatment
Arm Title
cleansing teeth with cotton roll
Arm Type
Experimental
Arm Description
cleansing teeth with cotton roll immediately following APF treatment
Arm Title
no fluoride therapy
Arm Type
No Intervention
Arm Description
control group
Intervention Type
Procedure
Intervention Name(s)
cleansing teeth after topical fluoride therapy
Intervention Description
washing with water 0, 15 or 30 min after APF treatment or cleansing teeth with cotton roll immediately following APF treatment.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
maximum pH drop
Time Frame
5,10,15,20 and 30 min after sucrose chalenge
Title
pH recovery time
Description
time for returning to the baseline pH
Time Frame
within 30 min after sucrose challenge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
healthy people (Without any systemic disease)
normal unstimulated salivary rate
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
fatemeh mazhari, Associate Professor
Organizational Affiliation
Mashhad University of Medical Siences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dental School - Mashhad University of Medical Siences
City
Mashhad
State/Province
Khorasan Razavi
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
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Effect of Water Rinsing After Topical Fluoride Application on Dental Plaque pH
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