Interactive Power Toothbrush With or Without App vs Manual Toothbrush
8 de diciembre de 2021 actualizado por: Sühan Gürbüz, Gazi University
The Effects of Interactive Powered Toothbrush With Application-assisted on Plaque, Gingivitis and Gingival Abrasion: A Randomized Controlled Clinical Trial.
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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
- Dispositivo: Oral-B Genius® 8000 power toothbrush with CrossAction brush head with smartphone app(Procter&Gamble,Ohio, USA)
- Dispositivo: Oral-B Genius® 8000 power toothbrush with CrossAction brush head without smartphone app(Procter&Gamble,Ohio, USA)
- Dispositivo: Oral B ClinicLine Pro-FlexSoft (Procter&Gamble,Ohio, USA)
Tipo de estudio
Intervencionista
Inscripción (Actual)
86
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Ankara, Pavo, 06490
- Sühan Gürbüz
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 25 años (Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: 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.
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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
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Comparador activo: 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).
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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.
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Comparador activo: 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.
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Turesky modification of the Quigley-Hein Plaque Index (QHPI-TM) index measurement
Periodo de tiempo: 2 weeks
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Tooth surfaces stained with Mira-2 Toneblue® were evaluated with six different scores: Score 0 = No plaque, Score 1 = Plaque stains on the cervical edge of the tooth, Score 2 = A thin, continuous strip of plaque (up to 1 mm) at the cervical edge of the tooth, Score 3 = band of plaque wider than 1 mm but covering less than one-third of the dental crown, Score 4 = Plaque covering at least one-third but less than two-thirds of the dental crown, Score 5 = Plaque covering two-thirds or more of the dental crown.
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2 weeks
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Turesky modification of the Quigley-Hein Plaque Index (QHPI-TM) index measurement
Periodo de tiempo: 8 weeks
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Tooth surfaces stained with Mira-2 Toneblue® were evaluated with six different scores: Score 0 = No plaque, Score 1 = Plaque stains on the cervical edge of the tooth, Score 2 = A thin, continuous strip of plaque (up to 1 mm) at the cervical edge of the tooth, Score 3 = band of plaque wider than 1 mm but covering less than one-third of the dental crown, Score 4 = Plaque covering at least one-third but less than two-thirds of the dental crown, Score 5 = Plaque covering two-thirds or more of the dental crown.
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8 weeks
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Bleeding on marginal bleeding index (BOMP) index measurement
Periodo de tiempo: 2 weeks
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The presence/absence and amount of bleeding were graded on a 0-2 scale within 30 seconds of probing by probing the gingival margin at an angle of approximately 60 to the long axis of the tooth (0 = no bleeding, 1 = punctate bleeding, 2 = excessive bleeding).
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2 weeks
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Bleeding on marginal bleeding index (BOMP) index measurement
Periodo de tiempo: 8 weeks
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The presence/absence and amount of bleeding were graded on a 0-2 scale within 30 seconds of probing by probing the gingival margin at an angle of approximately 60 to the long axis of the tooth (0 = no bleeding, 1 = punctate bleeding, 2 = excessive bleeding).
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8 weeks
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Staining with Mira-2 Toneblue® to detect the gingival abrasion scores
Periodo de tiempo: 2 weeks
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Blue or purple visible abrasions were classified by measuring with a Williams periodontal probe placed along the long axis of the lesions ("small" if ≤2 mm, "moderate" if ≥3 mm and ≤5 mm, and "large" if >5 mm).
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2 weeks
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Staining with Mira-2 Toneblue® to detect the gingival abrasion scores
Periodo de tiempo: 8 weeks
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Blue or purple visible abrasions were classified by measuring with a Williams periodontal probe placed along the long axis of the lesions ("small" if ≤2 mm, "moderate" if ≥3 mm and ≤5 mm, and "large" if >5 mm).
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8 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Brushing times
Periodo de tiempo: 8 weeks
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The records in PTB group without-app and MTB were obtained with digital timer.
In contrast, these records were obtained at the last appointment of the study; in Group PTB-A, the last brushing time records were sent to the researcher via e-mail by using the integral timer of the toothbrush, which is a feature of the mobile application.
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8 weeks
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Questionnaire
Periodo de tiempo: 8 weeks
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Questionnaire was applied to the participants including post-brushing pain/tenderness, cleaning capacity, manageability, and willingness to purchase via Visual Analogue Scale. Subjects were asked to mark a point on a 10 cm long uncalibrated line, with both ends interpreted as negative (left) or positive (right) ends. |
8 weeks
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
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Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
12 de mayo de 2017
Finalización primaria (Actual)
17 de agosto de 2017
Finalización del estudio (Actual)
17 de agosto de 2017
Fechas de registro del estudio
Enviado por primera vez
27 de noviembre de 2021
Primero enviado que cumplió con los criterios de control de calidad
27 de noviembre de 2021
Publicado por primera vez (Actual)
8 de diciembre de 2021
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
29 de diciembre de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
8 de diciembre de 2021
Última verificación
1 de diciembre de 2021
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- 123456 (Innovate UK)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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