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Dental PlaqueNCT01900353

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

A study testing brushing methods in people with Dental Plaque, run by University of Milan at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 to 24 yearsHealthy volunteers can take part
Conditions the study is for
Dental Plaque
What is being tested?
brushing methods
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
1 siteItaly
Study dates
Oct 2012to Dec 2012
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 24 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • seven evaluable teeth in each quadrant

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Italy1 site
  • Dental Clinic San Paolo Hospital

    Milan, 20142

Other trials in Italy

About this study

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

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.

Read the 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.

Clinical parameters were recorded by one examiner (SM), using a mouth plane mirror (Hu-Friedy, Nr. 5, diameter mm 24) and a millimeter periodontal probe (Hu-Friedy, CP-15,5B - Qulix) under optimal artificial lighting. The examiner (SM) was previously calibrated.

Toothbrushing Subjects were asked to abstain from oral hygiene procedures for 48 hours before the brushing session to allow adequate plaque accumulation. Before the brushing session, all subjects used a dental disclosing tablet (Red-Cote, D\&C Red #28, 1.5% w/w, Sunstar Suisse S.A., 20147 Saronno, Italy) to easily detect dental plaque on teeth and to highlight soft tissue abrasions following strictly the manufacturer's directions: rinse mouth with water, chew a tablet swishing around for 30 seconds, expectorate, and rinse again with water.

The same model of manual toothbrush was used for all subjects (Mentadent Tecnic Clean, Medium, Unilever Austria GmbH, 1023 Wien). The number of movements of the bristles on each tooth surfaces was set as five.

In the vertical toothbrushing method, the dental hygienist placed the bristles on the gingival margin of the teeth (two teeth are generally covered by toothbrush head) and moved the toothbrush in the occlusal direction; this movement was repeated five times for each couple of teeth, for buccal and lingual side. In the horizontal toothbrushing method, the bristles were placed on the teeth surfaces (the width of the toothbrush head covered the entire tooth surface) and moved distal to mesial and mesial to distal until the fifth movement was reached. The movements were performed one for posterior teeth and one for anterior teeth (canine and lateral incisor.

At the end of the brushing session, subjects were invited to repeat the disclosing procedure to highlight soft tissue abrasions produced by the bristles.

Plaque index evaluation The plaque scores were recorded two times, before and after the brushing, by one examiner (SM). The Rustogi Modified Navy Plaque Index was used(Rustogi 1992). The index evaluates 18 records. The buccal and the lingual surfaces of each tooth are ideally divided in 9 areas, scored as 0 (absence of disclosed plaque) or 1 (presence of disclosed plaque). The 9 areas are called a, b, c, d, e, f, g, h and i and they refer to the whole buccal and lingual surfaces: areas a, b and c refer to the gingival margin, areas d and f to approximal surfaces, areas e,h, and g to the middle areas of the surface and finally, area i refers to cuspal margin.

The mean plaque scores was calculated for the whole tooth surface, the gingival and in the interproximal areas scores for each subject.

The third molars, if present, were excluded from recordings. Plaque index of the central incisors was not considered because of the over-brushing depending on the split-mouth design of the study.

Gingival abrasions evaluation Gingival abrasions were assessed utilizing the method adapted by Danser (Danser 1998). The gingival tissues were divided into three areas defined as marginal for the marginal free gingiva, interdental for the papillary-free gingiva and mid-gingival for the attached gingiva. In the upper jaw the palatal mid-gingival area comprised the whole hard palate. The abrasions were measured using a periodontal probe placed along the axis of the lesion; they were classified as small (≥ 2 mm), medium (≥ 3 mm but ≤ 5 mm) and large (> 5 mm).

Conditions
Dental Plaque
Being tested
brushing methods
Medical subject headings
Dental Plaque

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • brushing methodsOther

Study groups in NCT01900353
Study groupRoleWhat they receive
horizontal brushing methodActive comparatorbrushing methods
Receives: Other: brushing methods
Vertical brushing methodActive comparatorbrushing methods
Receives: Other: brushing methods

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. dental plaque score

    Measured: 48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2013 (estimated)
  2. Study startOct 2012
  3. Primary completionDec 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01900353
Sponsor's protocol ID
2012CC01
Status last verified
Jul 2013
First submitted
11 Jul 2013
Last updated
16 Jul 2013
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 18853203

Questions about this trial

What is this clinical trial studying?

A study testing brushing methods in people with Dental Plaque, run by University of Milan at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

dental plaque score (time frame: 48 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01900353, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2013.

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