Purpose: To assess the efficacy and the safety of tooth bleaching procedure using Y10 Whitening toothpaste and RF current (Y10 Device), versus placebo (no RF current and off- the -shelf non bleaching toothpaste) in healthy patients seeking tooth bleaching.
No. of Subjects/Sites: A total of 60 patients at Hadassah Medical Center will be randomized, 30 patients for the test arm, and 30 patients for the placebo arm.
A 40% to 60% male (or female) ratio will be maintained.
Target teeth: At least 4 teeth between teeth 13-23 (Upper front teeth) according to the international teeth numbering system.
Upper and lower teeth will be treated with the same treatment arm as described.
Endpoints:
Primary endpoint:
• At the end of the treatment (V3), compared to prior of treatment, the mean shade change will be at least two shades (Vita Bleachguide 3D Master, Vita P/N: B361) as measured at the middle one-third area of the labial surface of the selected target teeth.
Secondary endpoints:
- Compared to prior of treatment, the mean shade change at 3 and 6 months will be at least one shade (Vita Bleachguide 3D Master, Vita P/N: B361) as measured at the middle one-third area of the labial surface of the selected target teeth.
- Compared to prior of treatment, color change evaluates with a spectrophotometer (VITA Easyshade Advance 4; VITA Zahnfabrik, Bad Sackingen, Germany), before and after treatment, at 3 and 6 months will be at least one shade. (Device with a high reliability, over 96%, Kim-Pusateri Et al. Reliability and accuracy of four dental shade-matching devices. Journal of Prosthetic Dentistry United States 2009;101(March (3)):193-9.)
- 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.
- 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.
- Compared to prior of treatment - teeth sensitivity to cold and touch stimulation - target teeth - VAS scale after treatment, 3 and 6 months. For the VAS, the participants will place a line perpendicular to a 10-mm-long line with zero at one end indicating ''no TS'' and the other end indicating ''unbearable TS.''
- Patient oral questionnaire - post treatment, 7 days, 3 months, 6 months (See below).
- Patient Reported Outcomes: (Scale 0-4). OHIP14-aesthetics questions for patients that received dental bleaching - (see below) - before treatment and in 3 months.
- Periodontal parameters at baseline, 3 and 6 months: plaque index, sulcular bleeding index, pocket depth - all at the target teeth. (See below details).
Inclusion criteria:
- 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
Exclusion criteria:
- 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.