NCT02971514

Brief 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 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.

Trial Health

80
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

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

November 11, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 23, 2016

Completed
Last Updated

November 23, 2016

Status Verified

November 1, 2016

Enrollment Period

11 months

First QC Date

November 11, 2016

Last Update Submit

November 19, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Dental plaque reduction

    Dental plaque assessed using a scale known as: "Rustogi Modified Navy Plaque Index"

    immediately Before brushing/ flossing and immediately after these procedures

Secondary Outcomes (1)

  • fluoride concentration in Interdental plaque

    Immediately after toothbrushing /flossing interdental plaque was collected for fluoride measurement

Study Arms (2)

Floss-Brush group

EXPERIMENTAL

The participants flossed first followed by brushing

Behavioral: Flossing before Brushing

Brush-Floss group

ACTIVE COMPARATOR

They used dental floss after brushing

Behavioral: Brushing before Flossing

Interventions

Floss-Brush group
Brush-Floss group

Eligibility Criteria

Age20 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Any systemic diseases Periodontal diseases Crowding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amir Moeintaghavi

Mashhad, Khorasan Razavi, 91735-984, Iran

Location

Related Publications (1)

  • 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.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor od Pedodontics

Study Record Dates

First Submitted

November 11, 2016

First Posted

November 23, 2016

Study Start

May 1, 2014

Primary Completion

April 1, 2015

Last Updated

November 23, 2016

Record last verified: 2016-11

Locations