ToothbrushesNCT05150132
Interactive Power Toothbrush With or Without App vs Manual Toothbrush
A study testing 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(Procter&Gamble,Ohio, USA) and Oral B ClinicLine Pro-FlexSoft (Procter&Gamble,Ohio, USA) in people with Toothbrushes, run by Gazi University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Toothbrushes
- What is being tested?
- 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(Procter&Gamble,Ohio, USA) and Oral B ClinicLine Pro-FlexSoft (Procter&Gamble,Ohio, USA)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 May 2017to 17 Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- Not undergoing orthodontic treatment
- No crowding
- No periodontal treatment in the last three months
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Toothbrushes
- Being tested
- 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(Procter&Gamble,Ohio, USA), Oral B ClinicLine Pro-FlexSoft (Procter&Gamble,Ohio, USA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral-B Genius® 8000 power toothbrush with CrossAction brush head with smartphone app(Procter&Gamble,Ohio, USA)Device
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
Oral-B Genius® 8000 power toothbrush with CrossAction brush head without smartphone app(Procter&Gamble,Ohio, USA)Device
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.
Oral B ClinicLine Pro-FlexSoft (Procter&Gamble,Ohio, USA)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Oral-B Genius® 8000 power toothbrush with Cross Action brush head with smartphone app for 8 weeks | Experimental | 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. Receives: 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 | 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). Receives: 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 | They were instructed to brush according to the Modified Bass technique. Receives: Device: Oral B ClinicLine Pro-FlexSoft (Procter&Gamble,Ohio, USA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Turesky modification of the Quigley-Hein Plaque Index (QHPI-TM) index measurement
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.
Measured: 2 weeks
Turesky modification of the Quigley-Hein Plaque Index (QHPI-TM) index measurement
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.
Measured: 8 weeks
Bleeding on marginal bleeding index (BOMP) index measurement
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).
Measured: 2 weeks
Bleeding on marginal bleeding index (BOMP) index measurement
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).
Measured: 8 weeks
Staining with Mira-2 Toneblue® to detect the gingival abrasion scores
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).
Measured: 2 weeks
Staining with Mira-2 Toneblue® to detect the gingival abrasion scores
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).
Measured: 8 weeks
Secondary outcomes (2)
Brushing times
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.
Measured: 8 weeks
Questionnaire
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start12 May 2017
- Primary completion17 Aug 2017
- Study completion17 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ToothbrushesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sühan Gürbüz, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05150132
- Sponsor's protocol ID
- 123456
- Status last verified
- Dec 2021
- First submitted
- 27 Nov 2021
- Last updated
- 29 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35614277
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Interactive Powered Toothbrush With Application-assisted on Plaque, Gingivitis and Gingival Abrasion: A Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT05150132
- Acronym / sponsor ID
- 123456
- Conditions
- Toothbrushes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 12 May 2017 (actual)
- Primary completion
- 17 Aug 2017 (actual)
- Study completion
- 17 Aug 2017 (actual)
- First posted
- 8 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oral-B Genius® 8000 power toothbrush with Cross Action brush head with smartphone app for 8 weeks | Experimental | Device: Oral-B Genius® 8000 power toothbrush with CrossAction brush head with smartphone app(Procter&Gamble,Ohio, USA)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. |
| Oral-B Genius® 8000 power toothbrush with CrossAction brush head without smartphone app for 8 weeks | Active comparator | Device: Oral-B Genius® 8000 power toothbrush with CrossAction brush head without smartphone app(Procter&Gamble,Ohio, USA)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). |
| Manual toothbrush: Oral B ClinicLine Pro-FlexSoft (Procter&Gamble,Ohio, USA) for 8 weeks | Active comparator | Device: Oral B ClinicLine Pro-FlexSoft (Procter&Gamble,Ohio, USA)They were instructed to brush according to the Modified Bass technique. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral-B Genius® 8000 power toothbrush with CrossAction brush head with smartphone app(Procter&Gamble,Ohio, USA)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 | Device | Oral-B Genius® 8000 power toothbrush with Cross Action brush head with smartphone app for 8 weeks |
| Oral-B Genius® 8000 power toothbrush with CrossAction brush head without smartphone app(Procter&Gamble,Ohio, USA)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. | Device | Oral-B Genius® 8000 power toothbrush with CrossAction brush head without smartphone app for 8 weeks |
| Oral B ClinicLine Pro-FlexSoft (Procter&Gamble,Ohio, USA)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. | Device | Manual toothbrush: Oral B ClinicLine Pro-FlexSoft (Procter&Gamble,Ohio, USA) for 8 weeks |
Primary outcome
Turesky modification of the Quigley-Hein Plaque Index (QHPI-TM) index measurement
Time frame: 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.
Turesky modification of the Quigley-Hein Plaque Index (QHPI-TM) index measurement
Time frame: 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.
Bleeding on marginal bleeding index (BOMP) index measurement
Time frame: 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).
Bleeding on marginal bleeding index (BOMP) index measurement
Time frame: 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).
Staining with Mira-2 Toneblue® to detect the gingival abrasion scores
Time frame: 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).
Staining with Mira-2 Toneblue® to detect the gingival abrasion scores
Time frame: 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).
2 secondary outcomes
Brushing times
Time frame: 8 weeks
Questionnaire
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2021.
- Derived from this study: PubMed 35614277Gurbuz 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.
- Individual participant dataSharing planned: No
Related trials for Toothbrushes
Not yet recruiting
Plaque Removal in Children Using Charcoal and Nylon Toothbrushes
Effectiveness of Charcoal-infused Versus Nylon Bristle Toothbrushes on Plaque Removal and Oral Bacterial Reduction in Children
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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(Procter&Gamble,Ohio, USA) and Oral B ClinicLine Pro-FlexSoft (Procter&Gamble,Ohio, USA) in people with Toothbrushes, run by Gazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Turesky modification of the Quigley-Hein Plaque Index (QHPI-TM) index measurement (time frame: 2 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05150132, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2021; AzTrials last refreshed its copy on 31 Oct 2026.