NCT01900353

Brief Summary

The aim of this randomized, single-blind, split-mouth design, clinical trial was to evaluate the effectiveness in plaque removal of the vertical and the horizontal brushing methods. Trauma on soft tissues were also registered. Sixty-one (61) young adults were enrolled for this trial and forty-three (43) completed the brushing session. All subject were asked to abstain from oral hygiene procedures for 48 hours before the brushing session to allow adequate plaque accumulation. They were firstly instructed to use a dental disclosing tablet in order to easily permit to detect dental plaque on teeth and to highlight soft tissue abrasions. Plaque and the abrasion indexes were recorded according to the Rustogi Modified Navy Plaque Index (RMNPI) and the Danser Index (DI) by the same examiner. The brushing session was always performed by the same dental hygienist who brush with a randomized split-mouth design. After the brushing session, the blinded examiner recorded the indexes again.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 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

October 1, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 16, 2013

Completed
Last Updated

July 16, 2013

Status Verified

July 1, 2013

Enrollment Period

2 months

First QC Date

July 11, 2013

Last Update Submit

July 11, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • dental plaque score

    48 hours

Study Arms (2)

horizontal brushing method

ACTIVE COMPARATOR

brushing methods

Other: brushing methods

Vertical brushing method

ACTIVE COMPARATOR

brushing methods

Other: brushing methods

Interventions

Vertical brushing methodhorizontal brushing method

Eligibility Criteria

Age19 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • seven evaluable teeth in each quadrant

You may not qualify if:

  • the presence of oral mucosal lesions, periodontal pocket ≥ 4 mm, gingival recession, orthodontic treatment, caries lesions in buccal and/or lingual surfaces, removable prosthesis, use of mouthrinses containing plaque-reducing agents (e.g. chlorhexidine, essential oils, cetylpyridinium chloride) on regular basis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dental Clinic San Paolo Hospital

Milan, 20142, Italy

Location

Related Publications (1)

  • Ganss C, Schlueter N, Preiss S, Klimek J. Tooth brushing habits in uninstructed adults--frequency, technique, duration and force. Clin Oral Investig. 2009 Jun;13(2):203-8. doi: 10.1007/s00784-008-0230-8. Epub 2008 Oct 14.

    PMID: 18853203BACKGROUND

MeSH Terms

Conditions

Dental Plaque

Condition Hierarchy (Ancestors)

Dental DepositsTooth DiseasesStomatognathic Diseases

Study Officials

  • Maria Grazia Cagetti, DDS PhD

    Department of Health Sciences, University of Milan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor senior researcher

Study Record Dates

First Submitted

July 11, 2013

First Posted

July 16, 2013

Study Start

October 1, 2012

Primary Completion

December 1, 2012

Last Updated

July 16, 2013

Record last verified: 2013-07

Locations