Genius Toothbrushes on Periodontal Status of Orthodontic Patients

NCT04235010 | Completed DMC

• 1 other identifier: 2018DISF007
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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).

Conditions

Periodontal Inflammation; Toothbrushing; Orthodontic Treatment

Keywords

Genius toothbrush; Orthodontic treatment; Periodontal health

Outcome Measures

Primary Outcomes (9)

• 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

  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

  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

  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.

  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.

  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.

  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.

  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.

  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.

  4 months

Study Arms (2)

Manual toothbrush

EXPERIMENTAL

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

Device: Manual toothbrush

Genius toothbrush

EXPERIMENTAL

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

Device: Genius toothbrush

Interventions

Genius toothbrush DEVICE

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

Genius toothbrush

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.

Manual toothbrush

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Pamukkale University Faculty of Dentistry Department of Orthodontics

Denizli, 20160, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The examiner who performed clinical periodontal parameters was blinded to group assignment.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 15, 2020
• First Posted: January 21, 2020
• Study Start: October 28, 2018
• Primary Completion: February 28, 2019
• Study Completion: March 28, 2019
• Last Updated: January 21, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)