Interactive Power Toothbrush With or Without App vs Manual Toothbrush

Gazi University

Status: Completed

Conditions: Toothbrushes

Treatments: Device: Oral B ClinicLine Pro-FlexSoft (Procter&Gamble,Ohio, USA); Device: Oral-B Genius® 8000 power toothbrush with CrossAction brush head with smartphone app(Procter&Gamble,Ohio, USA); Device: Oral-B Genius® 8000 power toothbrush with CrossAction brush head without smartphone app(Procter&Gamble,Ohio, USA)

Study type: Interventional

Funder types: Other

Identifiers

NCT05150132

123456

Details and patient eligibility

About

It has been suggested that interactive power toothbrushes (PTBs), developed in recent years, provide more successful results in plaque control and effective use of brushing time by enabling patient collaboration and self-treatment, thanks to the application features associated with mobile phones. Interactive PTB synchronized with smartphones, including real-time feedback, session length, applications that prevent excessive brushing force, and focus brushing on specific areas with position detection technology, increases the brushing performance by increasing oral hygiene motivation.

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.

Enrollment: 86 patients

Sex: All

Ages: 18 to 25 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Dental students
• 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 power toothbrush before
• Use of drugs that may affect the gingival tissues
• Having mucogingival problems
• Having carious teeth that require urgent treatment
• Probing pocket depths ˃ 3mm

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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86 participants in 3 patient groups

Oral-B Genius® 8000 power toothbrush with Cross Action brush head with smartphone app for 8 weeks

Experimental group

Description:

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.

Treatment:

Device: Oral-B Genius® 8000 power toothbrush with CrossAction brush head with smartphone app(Procter&Gamble,Ohio, USA)

Oral-B Genius® 8000 power toothbrush with CrossAction brush head without smartphone app for 8 weeks

Active Comparator group

Description:

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).

Treatment:

Device: Oral-B Genius® 8000 power toothbrush with CrossAction brush head without smartphone app(Procter&Gamble,Ohio, USA)

Manual toothbrush: Oral B ClinicLine Pro-FlexSoft (Procter&Gamble,Ohio, USA) for 8 weeks

Active Comparator group

Description:

They were instructed to brush according to the Modified Bass technique.

Treatment:

Device: Oral B ClinicLine Pro-FlexSoft (Procter&Gamble,Ohio, USA)