Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Interactive Power Toothbrush With or Without App vs Manual Toothbrush

8 dicembre 2021 aggiornato da: 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.

Panoramica dello studio

Tipo di studio

Interventistico

Iscrizione (Effettivo)

86

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

      • Ankara, Tacchino, 06490
        • Sühan Gürbüz

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 25 anni (Adulto)

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
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
Comparatore attivo: 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).
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.
Comparatore attivo: 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.
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Turesky modification of the Quigley-Hein Plaque Index (QHPI-TM) index measurement
Lasso di tempo: 2 weeks
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.
2 weeks
Turesky modification of the Quigley-Hein Plaque Index (QHPI-TM) index measurement
Lasso di tempo: 8 weeks
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.
8 weeks
Bleeding on marginal bleeding index (BOMP) index measurement
Lasso di tempo: 2 weeks
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).
2 weeks
Bleeding on marginal bleeding index (BOMP) index measurement
Lasso di tempo: 8 weeks
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).
8 weeks
Staining with Mira-2 Toneblue® to detect the gingival abrasion scores
Lasso di tempo: 2 weeks
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).
2 weeks
Staining with Mira-2 Toneblue® to detect the gingival abrasion scores
Lasso di tempo: 8 weeks
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).
8 weeks

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Brushing times
Lasso di tempo: 8 weeks
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.
8 weeks
Questionnaire
Lasso di tempo: 8 weeks

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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

12 maggio 2017

Completamento primario (Effettivo)

17 agosto 2017

Completamento dello studio (Effettivo)

17 agosto 2017

Date di iscrizione allo studio

Primo inviato

27 novembre 2021

Primo inviato che soddisfa i criteri di controllo qualità

27 novembre 2021

Primo Inserito (Effettivo)

8 dicembre 2021

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

29 dicembre 2021

Ultimo aggiornamento inviato che soddisfa i criteri QC

8 dicembre 2021

Ultimo verificato

1 dicembre 2021

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 123456 (UMMashhad)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

3
Sottoscrivi