Genius Toothbrushes on Periodontal Status of Orthodontic Patients

Periodontal Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04235010
• Other study ID #: 2018DISF007
• Status: Completed
• Phase: N/A
• Start date: October 28, 2018
• Est. completion date: March 28, 2019

Study information

• Verified date: January 2020
• Source: Pamukkale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. The others received genius orthodontic toothbrush (Oral B Genius 8900, Procter & Gamble, USA) with Oral-B CrossAction brush head, Procter & Gamble, USA).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: March 28, 2019
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammation
• Orthodontic Treatment
• Periodontal Inflammation
• Toothbrushing

Intervention

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

Locations

Country	Name	City	State
Turkey	Pamukkale University Faculty of Dentistry Department of Orthodontics	Deni?zli?

Sponsors (1)

Lead Sponsor	Collaborator
Pamukkale University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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