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.
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.
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 group | Role | What they receive |
|---|---|---|
| horizontal brushing method | Active comparator | brushing methods Receives: Other: brushing methods |
| Vertical brushing method | Active comparator | brushing methods Receives: Other: brushing methods |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted16 Jul 2013 (estimated)
- Study startOct 2012
- Primary completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental PlaqueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Grazia Cagetti, University of Milan
- Investigators
- Maria Grazia Cagetti, DDS PhD, Principal investigator, Department of Health Sciences, University of Milan
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vertical Versus Horizontal Brushing: a Randomized Split-mouth Clinical Trial
- ClinicalTrials.gov ID
- NCT01900353
- Acronym / sponsor ID
- 2012CC01
- Conditions
- Dental Plaque
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Dec 2012 (actual)
- First posted
- 16 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| horizontal brushing method | Active comparator | Other: brushing methodsbrushing methods |
| Vertical brushing method | Active comparator | Other: brushing methodsbrushing methods |
Who may qualify
- Ages
- 19 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- seven evaluable teeth in each quadrant
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| brushing methods | Other | Vertical brushing method, horizontal brushing method |
Primary outcome
dental plaque score
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2013.
- Background: PubMed 18853203Ganss 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Grazia Cagetti, DDS PhD principal investigator
Department of Health Sciences, University of Milan
1 site in 1 country: see every site and its status.
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.