NCT01569165

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 3, 2012

Completed
Last Updated

April 3, 2012

Status Verified

March 1, 2012

Enrollment Period

8 months

First QC Date

March 29, 2012

Last Update Submit

March 30, 2012

Conditions

Keywords

AcidogenicityAcidulated phosphate fluoridedental plaquewater rinsing

Outcome Measures

Primary Outcomes (1)

  • dental plaque PH

    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

    5,10,15,20 and 30 min after sucrose chalenge

  • pH recovery time

    within 30 min after sucrose challenge

Study Arms (5)

washing after 30 min

EXPERIMENTAL

washing with water after 30 min following APF treatment

Procedure: cleansing teeth after topical fluoride therapy

washing after 15 min

EXPERIMENTAL

washing with water after 15 min following APF treatment

Procedure: cleansing teeth after topical fluoride therapy

immediately washing with water

EXPERIMENTAL

immediately washing with water after APF treatment

Procedure: cleansing teeth after topical fluoride therapy

cleansing teeth with cotton roll

EXPERIMENTAL

cleansing teeth with cotton roll immediately following APF treatment

Procedure: cleansing teeth after topical fluoride therapy

no fluoride therapy

NO INTERVENTION

control group

Interventions

washing with water 0, 15 or 30 min after APF treatment or cleansing teeth with cotton roll immediately following APF treatment.

cleansing teeth with cotton rollimmediately washing with waterwashing after 15 minwashing after 30 min

Eligibility Criteria

Age21 Years - 29 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy people (Without any systemic disease)
  • normal unstimulated salivary rate

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dental School - Mashhad University of Medical Siences

Mashhad, Khorasan Razavi, Iran

Location

MeSH Terms

Conditions

Dental CariesDental Plaque

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic DiseasesDental Deposits

Study Officials

  • fatemeh mazhari, Associate Professor

    Mashhad University of Medical Siences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

March 29, 2012

First Posted

April 3, 2012

Study Start

February 1, 2011

Primary Completion

October 1, 2011

Study Completion

November 1, 2011

Last Updated

April 3, 2012

Record last verified: 2012-03

Locations