NCT02412358

Brief Summary

  • Objective: To compare clinical results of three types of manual tooth brushes on gingivitis and plaque removal efficacy.
  • Material and Methods: This study is a single blind randomized trial with crossover design which involved 30 periodontally healthy individuals. At baseline professional plaque removal and oral hygiene instruction are performed for all the students, then they are asked to avoid brushing for 1-2 days. Thereafter plaque and gingivitis scores are measured using plaque and gingival indices (PI and GI). Then subjects are instructed to use Pulsar tooth brush for a two-week period and then, GI and PI indices are assessed again. After passing one-week period for wash out, subjects don't brush for 1-2 days and indices are recorded again. The same procedure are done for Cross action, and Butler 411 tooth brushes respectively.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started May 2008

Typical duration for not_applicable healthy

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

May 1, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
5.8 years until next milestone

First Submitted

Initial submission to the registry

April 6, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 9, 2015

Completed
Last Updated

January 7, 2020

Status Verified

January 1, 2020

Enrollment Period

6 months

First QC Date

April 6, 2015

Last Update Submit

January 5, 2020

Conditions

Keywords

toothbrushingplaque controlgingivitis

Outcome Measures

Primary Outcomes (2)

  • Plaque Index

    it is an index used for scoring plaque accumulation

    2 weeks

  • Gingival index

    it is an index used for scoring gingival inflammation

    2 weeks

Study Arms (3)

Pulsar

ACTIVE COMPARATOR

Patients use Pulsar toothbrush for plaque removal

Device: toothbrush

Crossaction

ACTIVE COMPARATOR

Patients use Crossaction toothbrush for plaque removal

Device: toothbrush

Butler

ACTIVE COMPARATOR

Patients use Butler toothbrush for plaque removal

Device: toothbrush

Interventions

Also known as: Pulsar, Crossaction, Butler toothbrush
ButlerCrossactionPulsar

Eligibility Criteria

Age18 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • having at least five teeth in each quadrant;
  • no partial denture;
  • no orthodontic banding or retention wires;
  • no oral lesions or sites with probing pockets depth ≥ 5 mm;
  • routine use of a manual toothbrush.

You may not qualify if:

  • having any systematic disease which would influence the course of periodontal diseases or the response to the treatment
  • smoking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amir Moeintaghavi

Mashhad, Khorasan Razavi, 91735-984, Iran

Location

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

InfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Amir Moeintaghavi, DDs., Msc.

    Mashhad University of Medical Sciences

    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
Professor of Periodontics

Study Record Dates

First Submitted

April 6, 2015

First Posted

April 9, 2015

Study Start

May 1, 2008

Primary Completion

November 1, 2008

Study Completion

June 1, 2009

Last Updated

January 7, 2020

Record last verified: 2020-01

Locations