The Efficacy and Safety of Tooth Bleaching Procedure Using Y10 Whitening Toothpaste and RF Current

NCT02841514 | Withdrawn

• 1 other identifier: CLD0043
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study title: The Efficacy and Safety of tooth bleaching procedure using Y10 Whitening toothpaste and RF current The Device: The Brighttonix Y10 Tooth Whitening system is indicated for use in painless non-invasive tooth whitening treatments. Design: Single center, randomized, controlled, double blind, two-arm, prospective clinical study. Follow up visits at 7 days (phone visit), 12 weeks and 26 weeks.

Conditions

Tooth Bleaching

Outcome Measures

Primary Outcomes (1)

• At the end of the treatment (V3), compared to prior of treatment, the mean shade change will be at least two shades (Vita Bleachguide) as measured at the middle one-third area of the labial surface of the selected target teeth.

  26 weeks

Secondary Outcomes (10)

• Compared to prior of treatment, the mean shade change at 3 and 6 months will be at least one shade (Vita Bleachguide) as measured at the middle one-third area of the labial surface of the selected target teeth.

  up to 26 weeks

• Compared to prior of treatment, color change evaluates with a spectrophotometer (VITA Easyshade) before and after treatment, at 3 and 6 months will be at least one shade.

  up to 26 weeks

• Compared to prior of treatment, the mean shade change for the lower teeth numbers 43-33 after treatment, 3 and 6 months will be at least one shade.

  up to 26 weeks

• Lesion in the gingiva of the upper and lower teeth (+/- in each of the teeth numbers 33-43, 13-23 after treatment and 3 months.

  12 weeks

• Compared to prior of treatment - teeth sensitivity to cold and touch stimulation - target teeth - VAS scale after treatment, 3 and 6 months.

  up to 26 weeks

Study Arms (2)

treatment group

EXPERIMENTAL

the operator will administer the Y10 whitening toothpaste in to the attachable mouthpiece and place it in the subject's mouth and turn on the device RF. After treating the patients for 30 minutes the operator will turn off the device and retrieve the mouthpiece from the mouth.

Device: The Y10 Tooth Whitening system including the Y10 toothpaste and the Y10 device

placebo group

PLACEBO COMPARATOR

the operator will administer an off the shelf regular toothpaste in to the attachable mouthpiece and place it in the subject's mouth. At this point the operator will switch on the device but the RF will not be activated. After 30 minutes the operator will turn off the device and retrieve the mouthpiece from the mouth.

Other: OTC toothpaste and an unoperated Y10 device

Interventions

The Y10 Tooth Whitening system including the Y10 toothpaste and the Y10 device DEVICE

treatment group

OTC toothpaste and an unoperated Y10 device OTHER

placebo group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Signed and dated Informed Consent Form.
• Normal and controlled general health.
• Male or female patients aged between 18-60 years old.
• Availability for the 37 weeks duration of the study.
• The patient has at least 4 natural teeth with no buccal restoration in the upper front area of the jaw (teeth 13-23), at least 2 of them with VITA shade \>15, in accordance with VITA Bleachedguide 3D-MASTER (P/N: B361, VITA Zahnfabrik H Rauter GmbH \& Co. KG, D-79713 Bad Sackingen, Germany).
• Females of childbearing potential must be non-pregnant or non-lactating during the course of the study

You may not qualify if:

• Underwent a teeth bleaching procedure in the last 3 years.
• Pockets of \>5 mm with BOP in the target area.
• Heavy smokers - \> 10 cigarettes per day.
• Tetracycline staining of target teeth.
• Presence of oral local mechanical factors that could (in the opinion of the Investigator) influence the outcome of the study.
• Presence of dental restorations in more than 2 teeth in the target area.
• Uncontrolled periodontitis or sever gingival inflammation
• Scheduled or simultaneous periodontal treatment.
• Presence of orthodontic appliances, or any removable appliances.
• Presence of soft or hard tissue tumours of the oral cavity.
• Presence of any of the following oral conditions: major recurrent aphthous ulcers, stomatitis, abscesses and related oral pathologies.
• The presence of any medical or psychiatric condition or any other condition that, in the opinion of the Investigator, could affect the successful participation of the patient in the study.
• Subject participates in any other clinical study 30 days prior to the start of the study and throughout the study duration.
• Implanted pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body
• Medical conditions of bleeding disorders, leukaemia, cirrhosis, vascular disease, sarcoidosis, active hepatitis, HIV.

Sponsors & Collaborators

• Brighttonix Medical Ltd.: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2016
• First Posted: July 22, 2016
• Study Start: September 1, 2016
• Primary Completion: April 1, 2017
• Last Updated: July 10, 2019

Record last verified: 2019-07