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Completed

NCT Number: NCT04235010

Genius Toothbrushes on Periodontal Status of Orthodontic Patients

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).

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Key information

Conditions

Periodontal Inflammation Orthodontic Treatment Toothbrushing

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pamukkale University Faculty of Dentistry Department of Orthodontics

Denizli, 20160, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Genius toothbrush

Device

Patients brushed their teeth twice a day for 2 minutes. An integral timer was used in the genius toothbrush group.

Manual toothbrush

Device

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 outcomes

  1. 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

  2. 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

  3. 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. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

Sponsors and collaborators

Lead sponsor

Pamukkale University

Other

Registry information

Official study title

Effects of Genius Toothbrushes on Periodontal Status of Patients Undergoing Fixed Orthodontic Treatment

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 21, 2020
Registry last updated
Jan 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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