Vertical Versus Horizontal Brushing: a Randomized Split-mouth Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Milan
- 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
brushing methods
Intervention: brushing methods (Other)
Vertical brushing method
brushing methods
Intervention: brushing methods (Other)
Outcomes
Primary Outcomes
dental plaque score
Time Frame: 48 hours
Secondary Outcomes
No secondary outcomes reported
Investigators
Maria Grazia Cagetti
Assistant professor senior researcher
University of Milan
