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PlaquePhase 4NCT03099551

Randomized Trial to Evaluate the Efficacy of Two Different Toothbrushes on Plaque Control

A Phase 4 study testing Group using manual toothbrush Curaprox 5460 Ultra Soft and Group using sonic toothbrush Edel White in people with Plaque and Gingivitis, run by Faculty Sao Leopoldo Mandic Campinas.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aim of the present study was to evaluate the efficacy of two different toothbrushes (manual and sonic) on plaque control Read more about this study

Who is it for?
Ages 15 to 20 yearsHealthy volunteers can take part
Conditions the study is for
Plaque, Gingivitis
What is being tested?
Group using manual toothbrush Curaprox 5460 Ultra Soft and Group using sonic toothbrush Edel White
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
No sites listed yet
Study dates
Dec 2016to Jun 2017
Phase
Phase 4
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 15 to 20 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Subjects had to be in generally good health, and possessing a minimum of 20 permanent natural teeth, excluding third molars.

Who cannot join

  • Subjects were excluded if they had fixed orthodontic appliances, advanced periodontal disease, limited manual dexterity, active caries, medical conditions limiting their salivary function or immunological condition, and if they were smokers.

About this study

The aim of the present study was to evaluate the efficacy of two different toothbrushes (manual and sonic) on plaque control

Read the detailed description

A parallel randomized clinical trial, examiner-blind, was conducted involving 56 patients with ages from 15 to 20, all students of CAMP (Centro de Formação e Integração Social), in the city of São Bernardo do Campo, state of São Paulo, Brazil. Randomization: the subjects were randomly allocated to two different groups (A for the manual toothbrush and B for the sonic toothbrush) by removing from an urn a paper with their respective group. Silness \& Löe Gingival Index, the Turesky Modification of the Quigley Hein Plaque Index and the Community Periodontal Index were evaluated at baseline and after 3 and 6 months.

Conditions
Plaque, Gingivitis
Being tested
Group using manual toothbrush Curaprox 5460 Ultra Soft, Group using sonic toothbrush Edel White
Keywords
Plaque, oral hygiene, gingivitis, sonic toothbrush, manual toothbrush
Medical subject headings
Plaque, Amyloid, Gingivitis

What participants receive

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

  • Group using manual toothbrush Curaprox 5460 Ultra SoftDevice

    Manual toothbrush usage with Bass technique twice a day during 2 minutes

  • Group using sonic toothbrush Edel WhiteDevice

    Sonic toothbrush usage twice a day during 2 minutes

Study groups in NCT03099551
Study groupRoleWhat they receive
Manual Toothbrush usersActive comparatorGroup using manual toothbrush Curaprox 5460 Ultra Soft
Receives: Device: Group using manual toothbrush Curaprox 5460 Ultra Soft
Sonic Toothbrush usersActive comparatorGroup using sonic toothbrush Edel White
Receives: Device: Group using sonic toothbrush Edel White

What is being measured

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

  1. Silness & Löe Gingival Index

    0 = Normal gingiva; 1 = Mild inflammation - slight change in colour, slight oedema. No bleeding on probing; 2 = Moderate inflammation - redness, oedema and glazing; bleeding on probing; 3 = Severe inflammation - marked redness and oedema. Ulceration. Tendency to spontaneous bleeding

    Measured: 6 months

  2. Turesky Modification of the Quigley Hein Plaque Index

    0 = No plaque; 1 = Separate flecks of plaque at the cervical margin of the tooth; 2 = A thin continuous band of plaque (up to one mm) at the cervical margin of the tooth; 3 = A band of plaque wider than one mm but covering less than one third of the crown of the tooth; 4 = Plaque covering at least one-third but less than two-thirds of the crown of the tooth; 5 = Plaque covering two-thirds or more of the crown of the tooth

    Measured: 6 months

  3. Community periodontal index

    0 = No periodontal disease; 1 = Bleeding on probing; 2 = Calculus with plaque seen or felt by probing.

    Measured: 6 months

Timeline

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

  1. First posted4 Apr 2017
  2. Study startDec 2016
  3. Primary completionMar 2017
  4. Study completionJun 2017 (estimated)

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 4
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03099551
Sponsor's protocol ID
1.672.795
Status last verified
Mar 2017
First submitted
28 Mar 2017
Last updated
4 Apr 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Aass AM, Gjermo P. Comparison of oral hygiene efficacy of one manual and two electric toothbrushes. Acta Odontol Scand. 2000 Aug;58(4):166-70. doi: 10.1080/000163500429163.

    PubMed 11045370

  • Araujo AC, Gusmao ES, Batista JE, Cimoes R. Impact of periodontal disease on quality of life. Quintessence Int. 2010 Jun;41(6):e111-8.

    PubMed 20490384

  • Ayad F, Petrone DM, Wachs GN, Mateo LR, Chaknis P, Panagakos F. Comparative efficacy of a specially engineered sonic powered toothbrush with unique sensing and control technologies to two commercially available power toothbrushes on established plaque and gingivitis. J Clin Dent. 2012;23 Spec No A:A5-10.

    PubMed 23448082

  • Barros VA, Costa SM, Zanin L, Florio FM. Evaluation of an educational activity in the oral health of students. Int J Dent Hyg. 2017 Feb;15(1):23-29. doi: 10.1111/idh.12152. Epub 2015 Jun 5.

    PubMed 26053214

  • BASS CC. The optimum characteristics of toothbrushes for personal oral hygiene. Dent Items Interest. 1948 Jul;70(7):697-718. No abstract available.

    PubMed 18871313

  • Borges Tde F, Regalo SC, Taba M Jr, Siessere S, Mestriner W Jr, Semprini M. Changes in masticatory performance and quality of life in individuals with chronic periodontitis. J Periodontol. 2013 Mar;84(3):325-31. doi: 10.1902/jop.2012.120069. Epub 2012 May 1.

    PubMed 22548588

  • Castro CO, Katiane SO, Carvalho RB, Garbin CAS, Bueno RN. Education and prevention programs for oral health in schools: a critical analysis of national publications. OdontolClín-Cient 2012 Jan-Mar; 11(1): 35-9.

  • Baccareli JC, Ribeiro MC. Sensibilidade dos Lactobacillus a anti-sépticos bucais. Rev Cienc Med, Campinas 2000; 9(3):99-104.

  • Chalub LLF, Péret ACA. Desempenho do Índice Periodontal Comunitário (CPI) na determinação da condição periodontal: enfoque no exame parcial. Revista do Arquivo Brasileiro de Odontologia. 2010;6(3):155-62.

  • Cifcibasi E, Koyuncuoglu CZ, Baser U, Bozacioglu B, Kasali K, Cintan S. Comparison of manual toothbrushes with different bristle designs in terms of cleaning efficacy and potential role on gingival recession. Eur J Dent. 2014 Jul;8(3):395-401. doi: 10.4103/1305-7456.137655.

    PubMed 25202222

  • Erbe C, Klukowska M, Tsaknaki I, Timm H, Grender J, Wehrbein H. Efficacy of 3 toothbrush treatments on plaque removal in orthodontic patients assessed with digital plaque imaging: a randomized controlled trial. Am J Orthod Dentofacial Orthop. 2013 Jun;143(6):760-6. doi: 10.1016/j.ajodo.2013.03.008.

    PubMed 23726325

  • Fjeld KG, Mowe M, Eide H, Willumsen T. Effect of electric toothbrush on residents' oral hygiene: a randomized clinical trial in nursing homes. Eur J Oral Sci. 2014 Apr;122(2):142-8. doi: 10.1111/eos.12113. Epub 2014 Jan 20.

    PubMed 24438077

  • Goyal CR, Qaqish J, He T, Grender J, Walters P, Biesbrock AR. A randomized 12-week study to compare the gingivitis and plaque reduction benefits of a rotation-oscillation power toothbrush and a sonic power toothbrush. J Clin Dent. 2009;20(3):93-8.

    PubMed 19711610

  • Goyal CR, Klukowska M, Grender JM, Cunningham P, Qaqish J. Evaluation of a new multi-directional power toothbrush versus a marketed sonic toothbrush on plaque and gingivitis efficacy. Am J Dent. 2012 Sep;25 Spec No A(A):21A-26A.

    PubMed 23248895

  • Grender J, Williams K, Walters P, Klukowska M, Reick H. Plaque removal efficacy of oscillating-rotating power toothbrushes: review of six comparative clinical trials. Am J Dent. 2013 Apr;26(2):68-74.

    PubMed 24073528

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Group using manual toothbrush Curaprox 5460 Ultra Soft and Group using sonic toothbrush Edel White in people with Plaque and Gingivitis, run by Faculty Sao Leopoldo Mandic Campinas.

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: status not confirmed, as of the sponsor's last update on 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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?

Silness & Löe Gingival Index (time frame: 6 months). The study lists 3 primary outcomes in all. 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 NCT03099551, which also lists 47 linked publications.

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 4 Apr 2017.

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