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Clinical Trials/NCT01900353
NCT01900353CompletedNot Applicable

Vertical Versus Horizontal Brushing: a Randomized Split-mouth Clinical Trial

University of Milan1 site in 1 country43 target enrollmentStarted: October 1, 2012Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
43
Locations
1
Primary Endpoint
dental plaque score

Study Overview

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.

Detailed Description

Study population The study was conducted from October 2012 to December 2012 in the Dental Clinic of San Paolo Hospital in Milan. Sixty-one (61) students (19-24 years) attending the Dental Clinic were contacted with an information leaflet, explaining the aim of the study and requesting their participation with signed consent. Forty-nine (80.33% of total sample) agree to participate and underwent to an oral examination. The presence of seven evaluable teeth in each quadrant was considered the inclusion criterion. Exclusion criteria were 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.

One (1) subject was excluded because of the presence of periodontal pockets. Forty-eight (48) young adults were enrolled, five (10.42% drop-out rate) subjects did not attend the scheduled appointment and so the study reports data on 43 subjects.

All subjects were given a thorough professional prophylaxis to remove plaque, stains and calculus. The study protocol was approved by the Ethical Committee of San Paolo Hospital.

Study design and calibration of the personnel The study was designed and performed as split-mouth design. The subjects were listed and a list of true random numbers was generated (www.random.org). The generator was set to produce a true random sequence of "1" and "2", where "1" represented a mouth in which first and third quadrants were brushed with vertical method and "2" in which second and fourth quadrants were brushed with the same method.

A dental hygienist performed the brushing sessions. A calibration course was carried out one week before the starting of the study. She applied the two brushing methods first on Columbia Dentoform® and after on 2 volunteers.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Investigator)

Eligibility Criteria

Ages
19 Years to 24 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •seven evaluable teeth in each quadrant

Exclusion Criteria

  • •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.

Arms & Interventions

horizontal brushing method

Active Comparator

brushing methods

Intervention: brushing methods (Other)

Vertical brushing method

Active Comparator

brushing methods

Intervention: brushing methods (Other)

Outcomes

Primary Outcomes

dental plaque score

Time Frame: 48 hours

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Maria Grazia Cagetti

Assistant professor senior researcher

University of Milan

Study Sites (1)

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