- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04235010
Genius Toothbrushes on Periodontal Status of Orthodontic Patients
January 17, 2020 updated by: Serpil Cokakoglu, Pamukkale University
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).
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Deni̇zli̇, Turkey, 20160
- Pamukkale University Faculty of Dentistry Department of Orthodontics
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Manual toothbrush
Patients used manual orthodontic toothbrush (Oral B Ortho, Procter & Gamble, USA) for four months
|
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.
|
Experimental: Genius toothbrush
Patients used genius orthodontic toothbrush (Oral B Genius 8900, Procter & Gamble, USA) for four months
|
Patients brushed their teeth twice a day for 2 minutes.
An integral timer was used in the genius toothbrush group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
1 month
|
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
|
2 months
|
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
|
4 months
|
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.
|
1 month
|
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.
|
2 months
|
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.
|
4 months
|
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.
|
1 month
|
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.
|
2 months
|
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.
|
4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 28, 2018
Primary Completion (Actual)
February 28, 2019
Study Completion (Actual)
March 28, 2019
Study Registration Dates
First Submitted
January 15, 2020
First Submitted That Met QC Criteria
January 17, 2020
First Posted (Actual)
January 21, 2020
Study Record Updates
Last Update Posted (Actual)
January 21, 2020
Last Update Submitted That Met QC Criteria
January 17, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018DISF007
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Periodontal Inflammation
-
British University In EgyptRecruitingPeriodontal Diseases | Periodontal Pocket | Periodontal Attachment Loss | Periodontal InflammationEgypt
-
Fundacion Clinica PardinasUniversidade da Coruña; University Hospital A CoruñaRecruitingPeriodontitis | Periodontal Diseases | Periodontal Attachment Loss | Periodontal InflammationSpain
-
University of BeykentCompletedPeriodontal Diseases | Periodontal Attachment Loss | Periodontal Inflammation | Periodontal Disease, AVDC Stage 3 | Periodontal Disease, AVDC Stage 4Turkey
-
Queen Mary University of LondonGeistlich Pharma AGNot yet recruitingPeriodontal Diseases | Wound Heal | Periodontal Pocket | Periodontal Attachment Loss | Periodontal InflammationUnited Kingdom
-
Caspar WohlfahrtDr Caspar Wohlfahrt; Dr Maria BaltaRecruitingPeriodontitis | Periodontal Diseases | Periodontal Pocket | Periodontal InflammationNorway
-
Didem OZKAL EMINOGLUThe Scientific and Technological Research Council of Turkey; Scientific Research...CompletedPeriodontitis | Periodontal Diseases | Acupuncture | Periodontal Pocket | Electroacupuncture | Periodontal InflammationTurkey
-
University of NebraskaCompletedPeriodontal InflammationUnited States
-
Texas A&M UniversityEnrolling by invitationPeriodontitis | Periodontal Diseases | Surgery | Periodontal Bone Loss | Periodontal Pocket | Periodontal Attachment Loss | Periodontal InflammationUnited States
-
Pamukkale UniversityCompletedPeriodontal InflammationTurkey
-
Cairo UniversityNot yet recruitingPeriodontitis | Periodontal Diseases | Periodontal Attachment Loss | Periodontal Inflammation | Periodontitis Stage I | Periodontitis Stage II
Clinical Trials on Manual toothbrush
-
Azienda Socio Sanitaria Territoriale degli Spedali...Completed
-
Procter and GambleCompletedGingivitis | Dental PlaqueCanada
-
Marmara UniversityCompletedPlaque, DentalTurkey
-
Riccardo PolosaRecruitingDental Plaque | Calculus, DentalItaly
-
Church & Dwight Company, Inc.CompletedDental Devices, Home CareUnited States
-
Church & Dwight Company, Inc.Completed
-
Church & Dwight Company, Inc.Completed
-
Dow University of Health SciencesRecruitingCerebral Palsy, MixedPakistan
-
Marmara UniversityRecruitingGingivitis | Oral Hygiene | Plaque, Dental | Dental Plaque | Periodontal IndexesTurkey
-
University of North Carolina, Chapel HillPhilips Oral HealthcareCompletedInflammation | PeriodontitisUnited States