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Genius Toothbrushes on Periodontal Status of Orthodontic Patients

Primary Purpose

Periodontal Inflammation, Toothbrushing, Orthodontic Treatment

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Genius toothbrush
Manual toothbrush
Sponsored by
Pamukkale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Periodontal Inflammation focused on measuring Genius toothbrush, Orthodontic treatment, Periodontal health

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Pamukkale University Faculty of Dentistry Department of Orthodontics

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Manual toothbrush

Genius toothbrush

Arm Description

Patients used manual orthodontic toothbrush (Oral B Ortho, Procter & Gamble, USA) for four months

Patients used genius orthodontic toothbrush (Oral B Genius 8900, Procter & Gamble, USA) for four months

Outcomes

Primary Outcome Measures

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
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
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
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
January 15, 2020
Last Updated
January 17, 2020
Sponsor
Pamukkale University
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1. Study Identification

Unique Protocol Identification Number
NCT04235010
Brief Title
Genius Toothbrushes on Periodontal Status of Orthodontic Patients
Official Title
Effects of Genius Toothbrushes on Periodontal Status of Patients Undergoing Fixed Orthodontic Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
October 28, 2018 (Actual)
Primary Completion Date
February 28, 2019 (Actual)
Study Completion Date
March 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pamukkale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Inflammation, Toothbrushing, Orthodontic Treatment
Keywords
Genius toothbrush, Orthodontic treatment, Periodontal health

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The examiner who performed clinical periodontal parameters was blinded to group assignment.
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Manual toothbrush
Arm Type
Experimental
Arm Description
Patients used manual orthodontic toothbrush (Oral B Ortho, Procter & Gamble, USA) for four months
Arm Title
Genius toothbrush
Arm Type
Experimental
Arm Description
Patients used genius orthodontic toothbrush (Oral B Genius 8900, Procter & Gamble, USA) for four months
Intervention Type
Device
Intervention Name(s)
Genius toothbrush
Intervention Description
Patients brushed their teeth twice a day for 2 minutes. An integral timer was used in the genius toothbrush group.
Intervention Type
Device
Intervention Name(s)
Manual toothbrush
Intervention Description
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.
Primary Outcome Measure Information:
Title
Löe and Silness gingival index measurement
Description
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
Time Frame
1 month
Title
Löe and Silness gingival index measurement
Description
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
Time Frame
2 months
Title
Löe and Silness gingival index measurement
Description
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
Time Frame
4 months
Title
Modified Silness and Löe plaque index measurement
Description
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.
Time Frame
1 month
Title
Modified Silness and Löe plaque index measurement
Description
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.
Time Frame
2 months
Title
Modified Silness and Löe plaque index measurement
Description
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.
Time Frame
4 months
Title
Bleeding on probing scores
Description
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.
Time Frame
1 month
Title
Bleeding on probing scores
Description
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.
Time Frame
2 months
Title
Bleeding on probing scores
Description
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.
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Pamukkale University Faculty of Dentistry Department of Orthodontics
City
Deni̇zli̇
ZIP/Postal Code
20160
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Genius Toothbrushes on Periodontal Status of Orthodontic Patients

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