Periodontal InflammationNCT04235010
Genius Toothbrushes on Periodontal Status of Orthodontic Patients
A study testing Genius toothbrush and Manual toothbrush in people with Periodontal Inflammation and Toothbrushing, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
This study evaluates the effects of genius toothbrushes on periodontal status of patients during fixed orthodontic treatment.Half of the patients received manual orthodontic toothbrushes (Oral B Ortho, Procter \& Gamble, USA) with V-shaped bristles and rounded ends. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Inflammation, Toothbrushing, Orthodontic Treatment
- What is being tested?
- Genius toothbrush and Manual toothbrush
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Oct 2018to 28 Mar 2019
- 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 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Permanent dentition with no missing teeth
- No systemic or severe periodontal problems
- Indication of non-extraction fixed orthodontic treatment
- No use of drugs in the past two months
- Absence of physical problems that prevent brushing
- Right handedness for brushing
Show all 9Show fewer
- Same bracket type (0.022 slot metal, conventional) and ligation technique (wire ligature)
- Finishing of leveling phase (use of rectangular wires)
- Initial total score was between 3 and 10 for the labial surface of each tooth according to the modified Silness and Löe plaque index
Who cannot join
- Missing teeth
- Systemic or severe periodontal problem
- Indication of extraction treatment
- Use of drugs in the past two months
- Levelling phase of fixed orthodontic treatment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Pamukkale University Faculty of Dentistry Department of Orthodontics
Denizli, 20160
About this study
Official title: Effects of Genius Toothbrushes on Periodontal Status of Patients Undergoing Fixed Orthodontic Treatment
This study evaluates the effects of genius toothbrushes on periodontal status of patients during fixed orthodontic treatment.Half of the patients received manual orthodontic toothbrushes (Oral B Ortho, Procter \& Gamble, USA) with V-shaped bristles and rounded ends. The others received genius orthodontic toothbrush (Oral B Genius 8900, Procter \& Gamble, USA) with Oral-B CrossAction brush head, Procter \& Gamble, USA).
Read the detailed description
Powered (genius) toothbrush with position detection technology provides patient to clean all areas of the mouth during the required time. By connecting phone to the Oral-B App, the genius toothbrush uses facial recognition technology to guide patient's brushing, zone to zone. Pressure control and personalization are another characteristics of these toothbrushes. Pressure sensor alerts patient if the brushing is too hard and helps her/him not to put too much pressure by reducing the speed of brush head. Due to the Bluetooth technology, toothbrushing can be performed more efficiently among orthodontic adolescent patients. In addition, the position detection and timer can be used to control which area is brushed in the mouth and how much total brushing time is continued. The application allows patient to see all the days brushing activity and real-time feedback on brushing habits can be received by this way.
- Being tested
- Genius toothbrush, Manual toothbrush
- Keywords
- Genius toothbrush, Orthodontic treatment, Periodontal health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genius toothbrushDevice
Patients brushed their teeth twice a day for 2 minutes. An integral timer was used in the genius toothbrush group.
Manual toothbrushDevice
Patients brushed their teeth twice a day for 2 minutes. During brushing, patients in manual group assigned to use their brushes were provided with a digital timer.
| Study group | Role | What they receive |
|---|---|---|
| Manual toothbrush | Experimental | Patients used manual orthodontic toothbrush (Oral B Ortho, Procter \& Gamble, USA) for four months Receives: Device: Manual toothbrush |
| Genius toothbrush | Experimental | Patients used genius orthodontic toothbrush (Oral B Genius 8900, Procter \& Gamble, USA) for four months Receives: Device: Genius toothbrush |
What is being measured
The primary outcome is the main question the study is designed to answer.
Löe and Silness gingival index measurement
A score from 0 to 3 is given. Grade 0 indicates normal gingiva; grade 1 mild inflammation with no bleeding; grade 2 moderate inflammation, erythema, swelling, bleeding on probing or when pressure applied; grade 3 severe inflammation, severe erythema and swelling, tendency toward spontaneous hemorrhage, some ulceration
Measured: 1 month
Löe and Silness gingival index measurement
A score from 0 to 3 is given. Grade 0 indicates normal gingiva; grade 1 mild inflammation with no bleeding; grade 2 moderate inflammation, erythema, swelling, bleeding on probing or when pressure applied; grade 3 severe inflammation, severe erythema and swelling, tendency toward spontaneous hemorrhage, some ulceration
Measured: 2 months
Löe and Silness gingival index measurement
A score from 0 to 3 is given. Grade 0 indicates normal gingiva; grade 1 mild inflammation with no bleeding; grade 2 moderate inflammation, erythema, swelling, bleeding on probing or when pressure applied; grade 3 severe inflammation, severe erythema and swelling, tendency toward spontaneous hemorrhage, some ulceration
Measured: 4 months
Modified Silness and Löe plaque index measurement
The buccal surface of each tooth is divided into four zones (mesial, distal, gingival and incisal) to the bracket. Each of the four sites of the buccal tooth surface is given a score from 0 to 3, where 0 indicates the absence of plaque; 1 indicates no plaque visible, but an accumulation of soft deposit on a probe when used to clean the surface; 2 indicates a moderate accumulation of soft deposit on the tooth which can be seen with the naked eye; and 3 indicates an abundance of soft matter on the tooth. For the analysis, values are summed to obtain a total score per participant.
Measured: 1 month
Modified Silness and Löe plaque index measurement
The buccal surface of each tooth is divided into four zones (mesial, distal, gingival and incisal) to the bracket. Each of the four sites of the buccal tooth surface is given a score from 0 to 3, where 0 indicates the absence of plaque; 1 indicates no plaque visible, but an accumulation of soft deposit on a probe when used to clean the surface; 2 indicates a moderate accumulation of soft deposit on the tooth which can be seen with the naked eye; and 3 indicates an abundance of soft matter on the tooth. For the analysis, values are summed to obtain a total score per participant.
Measured: 2 months
Modified Silness and Löe plaque index measurement
The buccal surface of each tooth is divided into four zones (mesial, distal, gingival and incisal) to the bracket. Each of the four sites of the buccal tooth surface is given a score from 0 to 3, where 0 indicates the absence of plaque; 1 indicates no plaque visible, but an accumulation of soft deposit on a probe when used to clean the surface; 2 indicates a moderate accumulation of soft deposit on the tooth which can be seen with the naked eye; and 3 indicates an abundance of soft matter on the tooth. For the analysis, values are summed to obtain a total score per participant.
Measured: 4 months
Bleeding on probing scores
A periodontal probe runs along the marginal gingiva at an angle of approximately 60° to the longitudinal axis of the tooth to determine whether probing elicited marginal bleeding (score 1) or not (score 0). The inflammation was recorded as bleeding scores if bleeding occurred within 30 seconds of probing. Bleeding on probing was estimated as a percentage.
Measured: 1 month
Bleeding on probing scores
A periodontal probe runs along the marginal gingiva at an angle of approximately 60° to the longitudinal axis of the tooth to determine whether probing elicited marginal bleeding (score 1) or not (score 0). The inflammation was recorded as bleeding scores if bleeding occurred within 30 seconds of probing. Bleeding on probing was estimated as a percentage.
Measured: 2 months
Bleeding on probing scores
A periodontal probe runs along the marginal gingiva at an angle of approximately 60° to the longitudinal axis of the tooth to determine whether probing elicited marginal bleeding (score 1) or not (score 0). The inflammation was recorded as bleeding scores if bleeding occurred within 30 seconds of probing. Bleeding on probing was estimated as a percentage.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2020
- Study start28 Oct 2018
- Primary completion28 Feb 2019
- Study completion28 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal InflammationStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serpil Cokakoglu, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04235010
- Sponsor's protocol ID
- 2018DISF007
- Status last verified
- Jan 2020
- First submitted
- 15 Jan 2020
- Last updated
- 21 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Genius Toothbrushes on Periodontal Status of Patients Undergoing Fixed Orthodontic Treatment
- ClinicalTrials.gov ID
- NCT04235010
- Acronym / sponsor ID
- 2018DISF007
- Keywords
- Genius toothbrush, Orthodontic treatment, Periodontal health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 28 Oct 2018 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 28 Mar 2019 (actual)
- First posted
- 21 Jan 2020 (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.
This study evaluates the effects of genius toothbrushes on periodontal status of patients during fixed orthodontic treatment.Half of the patients received manual orthodontic toothbrushes (Oral B Ortho, Procter \& Gamble, USA) with V-shaped bristles and rounded ends. The others received genius orthodontic toothbrush (Oral B Genius 8900, Procter \& Gamble, USA) with Oral-B CrossAction brush head, Procter \& Gamble, USA).
Detailed description
Powered (genius) toothbrush with position detection technology provides patient to clean all areas of the mouth during the required time. By connecting phone to the Oral-B App, the genius toothbrush uses facial recognition technology to guide patient's brushing, zone to zone. Pressure control and personalization are another characteristics of these toothbrushes. Pressure sensor alerts patient if the brushing is too hard and helps her/him not to put too much pressure by reducing the speed of brush head. Due to the Bluetooth technology, toothbrushing can be performed more efficiently among orthodontic adolescent patients. In addition, the position detection and timer can be used to control which area is brushed in the mouth and how much total brushing time is continued. The application allows patient to see all the days brushing activity and real-time feedback on brushing habits can be received by this way.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual toothbrush | Experimental | Device: Manual toothbrushPatients used manual orthodontic toothbrush (Oral B Ortho, Procter \& Gamble, USA) for four months |
| Genius toothbrush | Experimental | Device: Genius toothbrushPatients used genius orthodontic toothbrush (Oral B Genius 8900, Procter \& Gamble, USA) for four months |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Permanent dentition with no missing teeth
- No systemic or severe periodontal problems
- Indication of non-extraction fixed orthodontic treatment
- No use of drugs in the past two months
- Absence of physical problems that prevent brushing
Key exclusion criteria (5 listed)
- Missing teeth
- Systemic or severe periodontal problem
- Indication of extraction treatment
- Use of drugs in the past two months
- Levelling phase of fixed orthodontic treatment
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 |
|---|---|---|
| Genius toothbrushPatients brushed their teeth twice a day for 2 minutes. An integral timer was used in the genius toothbrush group. | Device | Genius toothbrush |
| Manual toothbrushPatients brushed their teeth twice a day for 2 minutes. During brushing, patients in manual group assigned to use their brushes were provided with a digital timer. | Device | Manual toothbrush |
Primary outcome
Löe and Silness gingival index measurement
Time frame: 1 month
A score from 0 to 3 is given. Grade 0 indicates normal gingiva; grade 1 mild inflammation with no bleeding; grade 2 moderate inflammation, erythema, swelling, bleeding on probing or when pressure applied; grade 3 severe inflammation, severe erythema and swelling, tendency toward spontaneous hemorrhage, some ulceration
Löe and Silness gingival index measurement
Time frame: 2 months
A score from 0 to 3 is given. Grade 0 indicates normal gingiva; grade 1 mild inflammation with no bleeding; grade 2 moderate inflammation, erythema, swelling, bleeding on probing or when pressure applied; grade 3 severe inflammation, severe erythema and swelling, tendency toward spontaneous hemorrhage, some ulceration
Löe and Silness gingival index measurement
Time frame: 4 months
A score from 0 to 3 is given. Grade 0 indicates normal gingiva; grade 1 mild inflammation with no bleeding; grade 2 moderate inflammation, erythema, swelling, bleeding on probing or when pressure applied; grade 3 severe inflammation, severe erythema and swelling, tendency toward spontaneous hemorrhage, some ulceration
Modified Silness and Löe plaque index measurement
Time frame: 1 month
The buccal surface of each tooth is divided into four zones (mesial, distal, gingival and incisal) to the bracket. Each of the four sites of the buccal tooth surface is given a score from 0 to 3, where 0 indicates the absence of plaque; 1 indicates no plaque visible, but an accumulation of soft deposit on a probe when used to clean the surface; 2 indicates a moderate accumulation of soft deposit on the tooth which can be seen with the naked eye; and 3 indicates an abundance of soft matter on the tooth. For the analysis, values are summed to obtain a total score per participant.
Modified Silness and Löe plaque index measurement
Time frame: 2 months
The buccal surface of each tooth is divided into four zones (mesial, distal, gingival and incisal) to the bracket. Each of the four sites of the buccal tooth surface is given a score from 0 to 3, where 0 indicates the absence of plaque; 1 indicates no plaque visible, but an accumulation of soft deposit on a probe when used to clean the surface; 2 indicates a moderate accumulation of soft deposit on the tooth which can be seen with the naked eye; and 3 indicates an abundance of soft matter on the tooth. For the analysis, values are summed to obtain a total score per participant.
Modified Silness and Löe plaque index measurement
Time frame: 4 months
The buccal surface of each tooth is divided into four zones (mesial, distal, gingival and incisal) to the bracket. Each of the four sites of the buccal tooth surface is given a score from 0 to 3, where 0 indicates the absence of plaque; 1 indicates no plaque visible, but an accumulation of soft deposit on a probe when used to clean the surface; 2 indicates a moderate accumulation of soft deposit on the tooth which can be seen with the naked eye; and 3 indicates an abundance of soft matter on the tooth. For the analysis, values are summed to obtain a total score per participant.
Bleeding on probing scores
Time frame: 1 month
A periodontal probe runs along the marginal gingiva at an angle of approximately 60° to the longitudinal axis of the tooth to determine whether probing elicited marginal bleeding (score 1) or not (score 0). The inflammation was recorded as bleeding scores if bleeding occurred within 30 seconds of probing. Bleeding on probing was estimated as a percentage.
Bleeding on probing scores
Time frame: 2 months
A periodontal probe runs along the marginal gingiva at an angle of approximately 60° to the longitudinal axis of the tooth to determine whether probing elicited marginal bleeding (score 1) or not (score 0). The inflammation was recorded as bleeding scores if bleeding occurred within 30 seconds of probing. Bleeding on probing was estimated as a percentage.
Bleeding on probing scores
Time frame: 4 months
A periodontal probe runs along the marginal gingiva at an angle of approximately 60° to the longitudinal axis of the tooth to determine whether probing elicited marginal bleeding (score 1) or not (score 0). The inflammation was recorded as bleeding scores if bleeding occurred within 30 seconds of probing. Bleeding on probing was estimated as a percentage.
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 21 Jan 2020.
- Individual participant dataSharing planned: No
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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 Genius toothbrush and Manual toothbrush in people with Periodontal Inflammation and Toothbrushing, run by Pamukkale 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 21 Jan 2020. 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?
Löe and Silness gingival index measurement (time frame: 1 month). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jan 2020.