Clinical trial NCT05150132: Interactive Power Toothbrush With or Without App vs Manual Toothbrush
Official title: The Effects of Interactive Powered Toothbrush With Application-assisted on Plaque, Gingivitis and Gingival Abrasion: A Randomized Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Toothbrushes
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2021-12-08
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Turesky modification of the Quigley-Hein Plaque Index (QHPI-TM) index measurement
timeFrame: 2 weeks
measure: Turesky modification of the Quigley-Hein Plaque Index (QHPI-TM) index measurement
timeFrame: 8 weeks
measure: Bleeding on marginal bleeding index (BOMP) index measurement
timeFrame: 2 weeks
measure: Bleeding on marginal bleeding index (BOMP) index measurement
timeFrame: 8 weeks
measure: Staining with Mira-2 Toneblue® to detect the gingival abrasion scores
timeFrame: 2 weeks
measure: Staining with Mira-2 Toneblue® to detect the gingival abrasion scores
timeFrame: 8 weeks
Secondary outcomes:
measure: Brushing times
timeFrame: 8 weeks
measure: Questionnaire
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Sühan Gürbüz
Study officials:
References:
citation: 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.