Interactive Power Toothbrush With or Without App vs Manual Toothbrush
8. Dezember 2021 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
- Gerät: Oral-B Genius® 8000 power toothbrush with CrossAction brush head with smartphone app(Procter&Gamble,Ohio, USA)
- Gerät: Oral-B Genius® 8000 power toothbrush with CrossAction brush head without smartphone app(Procter&Gamble,Ohio, USA)
- Gerät: Oral B ClinicLine Pro-FlexSoft (Procter&Gamble,Ohio, USA)
Studientyp
Interventionell
Einschreibung (Tatsächlich)
86
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Ankara, Truthahn, 06490
- Sühan Gürbüz
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre bis 25 Jahre (Erwachsene)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Alle
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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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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Aktiver Komparator: 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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Aktiver Komparator: 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Turesky modification of the Quigley-Hein Plaque Index (QHPI-TM) index measurement
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Brushing times
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
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Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
12. Mai 2017
Primärer Abschluss (Tatsächlich)
17. August 2017
Studienabschluss (Tatsächlich)
17. August 2017
Studienanmeldedaten
Zuerst eingereicht
27. November 2021
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
27. November 2021
Zuerst gepostet (Tatsächlich)
8. Dezember 2021
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
29. Dezember 2021
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
8. Dezember 2021
Zuletzt verifiziert
1. Dezember 2021
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- 123456 (UMMashhad)
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