Interactive Power Toothbrush With or Without App vs Manual Toothbrush
NCT ID: NCT05150132
Last Updated: 2021-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
86 participants
INTERVENTIONAL
2017-05-12
2017-08-17
Brief Summary
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Studies report that both power and manual toothbrushes cause gingival abrasion, a localized reversible lesion of the epithelium. While the opinions about the cause of gingival abrasion are not clear yet, the discussions regarding brush strength yet continue. While it is possible to control the interactive PTB force thanks to the mobile application, it is known that these high-speed rotating brushes control plaque effectively, but there is not enough evidence about its effect on gingival abrasion.
The primary purpose of this clinical study is to determine whether interactive PTB with application feature provides an additional benefit on plaque removal efficacy and reduction of gingival inflammation. In addition, this study aims to determine the effect of interactive power toothbrush with application on gingival abrasion by comparing it to interactive PTB without application and manual toothbrush. The study's null hypothesis in terms of gingival abrasion is that interactive PTB do not show a significant difference from other brushing methods.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Oral-B Genius® 8000 power toothbrush with Cross Action brush head with smartphone app for 8 weeks
Interactive PTB with Bluetooth® 4.0 connectivity smartphone app with Cross Action brush head using visually position detection feature. A triple pressure control system stops vibration, gives a visual warning, and reduces rotation speed in Daily Cleaning Mode-1.
Oral-B Genius® 8000 power toothbrush with CrossAction brush head with smartphone app(Procter&Gamble,Ohio, USA)
All the participants were asked to brush with fluoride toothpaste (Pro-Expert Professional Protection- Ipana, Gross-Gerau, Germany) with a pea-sized amount (0.25 g) of the toothbrushes, which were given oral and applied instructions for use, twice a day in the morning and evening. The installation and operation of the toothbrush application (app) on the smartphone was activated in the PTB with the app group
Oral-B Genius® 8000 power toothbrush with CrossAction brush head without smartphone app for 8 weeks
PTB without Bluetooth® 4.0 connectivity without smartphone app with Cross Action brush head without using visually position detection feature triple pressure control system stops vibration, provides visual warning and reduces rotation speed. The group was asked to use PTB with daily cleaning mode 1 and brush head, but without using the Bluetooth app (without using the position detection system).
Oral-B Genius® 8000 power toothbrush with CrossAction brush head without smartphone app(Procter&Gamble,Ohio, USA)
All the participants were asked to brush with fluoride toothpaste (Pro-Expert Professional Protection- Ipana, Gross-Gerau, Germany) with a pea-sized amount (0.25 g) of the toothbrushes, which were given oral and applied instructions for use, twice a day in the morning and evening. The installation and operation of the toothbrush application (app) on the smartphone were not activated in the PTB without the app group.
Manual toothbrush: Oral B ClinicLine Pro-FlexSoft (Procter&Gamble,Ohio, USA) for 8 weeks
They were instructed to brush according to the Modified Bass technique.
Oral B ClinicLine Pro-FlexSoft (Procter&Gamble,Ohio, USA)
All the participants were asked to brush with fluoride toothpaste (Pro-Expert Professional Protection- Ipana, Gross-Gerau, Germany) with a pea-sized amount (0.25 g) of the toothbrushes, which were given oral and applied instructions for use, twice a day in the morning and evening. They were instructed to brush with the Modified Bass technique.
Interventions
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Oral-B Genius® 8000 power toothbrush with CrossAction brush head with smartphone app(Procter&Gamble,Ohio, USA)
All the participants were asked to brush with fluoride toothpaste (Pro-Expert Professional Protection- Ipana, Gross-Gerau, Germany) with a pea-sized amount (0.25 g) of the toothbrushes, which were given oral and applied instructions for use, twice a day in the morning and evening. The installation and operation of the toothbrush application (app) on the smartphone was activated in the PTB with the app group
Oral-B Genius® 8000 power toothbrush with CrossAction brush head without smartphone app(Procter&Gamble,Ohio, USA)
All the participants were asked to brush with fluoride toothpaste (Pro-Expert Professional Protection- Ipana, Gross-Gerau, Germany) with a pea-sized amount (0.25 g) of the toothbrushes, which were given oral and applied instructions for use, twice a day in the morning and evening. The installation and operation of the toothbrush application (app) on the smartphone were not activated in the PTB without the app group.
Oral B ClinicLine Pro-FlexSoft (Procter&Gamble,Ohio, USA)
All the participants were asked to brush with fluoride toothpaste (Pro-Expert Professional Protection- Ipana, Gross-Gerau, Germany) with a pea-sized amount (0.25 g) of the toothbrushes, which were given oral and applied instructions for use, twice a day in the morning and evening. They were instructed to brush with the Modified Bass technique.
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with gingivitis
* Clinical measurements: Probing pocket depths ≤3 mm, QHPI-TM ≥ 1.75 and with a bleeding site of at least 40% or more
* Aged between 18-25
* Non-smoker
* No systemic diseases
* Not undergoing orthodontic treatment
* No crowding
* No periodontal treatment in the last three months
Exclusion Criteria
* Use of drugs that may affect the gingival tissues
* Having mucogingival problems
* Having carious teeth that require urgent treatment
* Probing pocket depths ˃ 3mm
18 Years
25 Years
ALL
Yes
Sponsors
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Gazi University
OTHER
Responsible Party
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Sühan Gürbüz
Principal Investigator
Locations
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Sühan Gürbüz
Ankara, , Turkey (Türkiye)
Countries
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References
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Gurbuz S, Cankaya ZT, Cinal E, Kocyigit EG, Bodur A. Effects of interactive power toothbrush with or without application assistance on the plaque, gingivitis, and gingival abrasion among dental students: a randomized controlled clinical trial. Clin Oral Investig. 2022 Sep;26(9):5931-5941. doi: 10.1007/s00784-022-04553-3. Epub 2022 May 26.
Other Identifiers
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123456
Identifier Type: -
Identifier Source: org_study_id