Tooth BleachingNCT02841514
The Efficacy and Safety of Tooth Bleaching Procedure Using Y10 Whitening Toothpaste and RF Current
A study testing The Y10 Tooth Whitening system including the Y10 toothpaste and the Y10 device and OTC toothpaste and an unoperated Y10 device in people with Tooth Bleaching, run by Brighttonix Medical Ltd..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Bleaching
- What is being tested?
- The Y10 Tooth Whitening system including the Y10 toothpaste and the Y10 device and OTC toothpaste and an unoperated Y10 device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 15Show fewer
- 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.
About this study
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.
Read the detailed description
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.
- Conditions
- Tooth Bleaching
- Being tested
- The Y10 Tooth Whitening system including the Y10 toothpaste and the Y10 device, OTC toothpaste and an unoperated Y10 device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Y10 Tooth Whitening system including the Y10 toothpaste and the Y10 deviceDevice
OTC toothpaste and an unoperated Y10 deviceOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: OTC toothpaste and an unoperated Y10 device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Compared to prior of treatment - teeth sensitivity to cold and touch stimulation - target teeth - VAS scale after treatment, 3 and 6 months.
Measured: up to 26 weeks
Patient oral questionnaire - post treatment, 7 days, 3 months, 6 months.
Measured: up to 26 weeks
Patient Reported Outcomes: (Scale 0-4). OHIP14-aesthetics questions for patients that received dental bleaching - (see below) - before treatment and in 3 months.
Measured: 12 weeks
Periodontal parameters at baseline, 3 and 6 months: plaque index - all at the target teeth.
Measured: up to 26 weeks
Periodontal parameters at baseline, 3 and 6 months: sulcular bleeding index- all at the target teeth.
Measured: up to 26 weeks
Periodontal parameters at baseline, 3 and 6 months: pocket depth - all at the target teeth.
Measured: up to 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2016 (estimated)
- Study startSep 2016
- Primary completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth BleachingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brighttonix Medical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02841514
- Sponsor's protocol ID
- CLD0043
- Status last verified
- Jul 2019
- First submitted
- 18 Jul 2016
- Last updated
- 10 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Tooth Bleaching Procedure Using Y10 Whitening Toothpaste and RF Current
- ClinicalTrials.gov ID
- NCT02841514
- Acronym / sponsor ID
- CLD0043
- Conditions
- Tooth Bleaching
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Brighttonix Medical Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2016
- Primary completion
- Apr 2017 (estimated)
- First posted
- 22 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Device: The Y10 Tooth Whitening system including the Y10 toothpaste and the Y10 devicethe 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. |
| placebo group | Placebo comparator | Other: OTC toothpaste and an unoperated Y10 devicethe 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 |
Primary outcome
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.
Time frame: 26 weeks
10 secondary outcomes
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 weeks
Compared to prior of treatment - teeth sensitivity to cold and touch stimulation - target teeth - VAS scale after treatment, 3 and 6 months.
Time frame: up to 26 weeks
Patient oral questionnaire - post treatment, 7 days, 3 months, 6 months.
Time frame: up to 26 weeks
Patient Reported Outcomes: (Scale 0-4). OHIP14-aesthetics questions for patients that received dental bleaching - (see below) - before treatment and in 3 months.
Time frame: 12 weeks
Periodontal parameters at baseline, 3 and 6 months: plaque index - all at the target teeth.
Time frame: up to 26 weeks
Periodontal parameters at baseline, 3 and 6 months: sulcular bleeding index- all at the target teeth.
Time frame: up to 26 weeks
Periodontal parameters at baseline, 3 and 6 months: pocket depth - all at the target teeth.
Time frame: up to 26 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing The Y10 Tooth Whitening system including the Y10 toothpaste and the Y10 device and OTC toothpaste and an unoperated Y10 device in people with Tooth Bleaching, run by Brighttonix Medical Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2019.