Tooth DiscolorationNCT04124068
Efficacy of Teeth Whitening Product Offerings in Adults
A study testing Hydrogen peroxide teeth whitening gel, GLO Brilliant Teeth Whitening Device and GLO Lit Teeth Whitening Device in people with Tooth Discoloration, run by Glo Science, Inc. at 1 site in United States.
Trial summary
This is a 30 day randomized, parallel comparative trial where participants with tooth shade of C2 or darker will be assigned to one of five groups. The participants will be evaluated for the difference in tooth shade, as determined by the digital VITA Easyshade V (provided by GLO) before the respective whitening… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Discoloration
- What is being tested?
- Hydrogen peroxide teeth whitening gel, GLO Brilliant Teeth Whitening Device and GLO Lit Teeth Whitening Device
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2019to 30 Dec 2019
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provide written informed consent to participate in the study.
- Be 18 to 65 years of age.
- Agree not to participate in any other oral/dental product studies during the trial.
- Agree to delay any elective dentistry (including dental prophylaxis) until the study has been completed.
- Agree to refrain from the use of any other teeth whitening products once assigned to a treatment group.
- Agree to refrain from the use of any oral care products that may cause staining (chlorhexidine rinses, stannous fluoride toothpaste, etc.).
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- Agree to return for all scheduled visits and follow study procedures.
- Be in good general health, as determined by the investigator/designee based on a review of the health history/update for participation in the study.
- Have at least 4 gradable maxillary anterior teeth ( canine to canine) with a Vita Shade average score of C2 or darker.
- Be willing to refrain from consuming stain-causing food and beverages (i.e., coffee, tea, red wine, berries, etc.) during the initial treatment duration (treatment period excluding the 4 week follow up).
- Be a current or recent non-smoker (no smoking for at least 3 months).
Who cannot join
- Are undergoing treatment for gingivitis, periodontitis, or caries.
- Presence of self-reported tooth sensitivity.
- Present with fixed orthodontic appliances on the facial surfaces of the maxillary arch.
- Have dental crowns, veneers or composite restorations on gradable maxillary anterior teeth ( canine to canine) or mandibular anterior teeth.
- Have any oral pathologies or gross neglect of home care requiring prompt treatment, including periodontal disease, as evidenced by purulent exudate, exposed root surfaces (generalized recession), tooth mobility, and/or other signs indicating that the integrity of the data collected for that subject might be compromised.
- Present with any pre-existing oral or medical condition that the Investigator/designee determines may place the subject at increased health risk from study participation.
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- Have meaningful malocclusion that would impact treatment or ease of viewing/scoring maxillary anterior teeth.
- Have teeth with severe or atypical intrinsic staining, such as that caused by tetracycline, fluorosis or hypocalcification.
- Have any known allergies to over-the-counter oral hygiene/whitening products.
- Have any known allergies to the trial product ingredients.
- Are pregnant and/or breastfeeding.
- Are current smokers.
Trial locations and contacts
1 site in 1 country.
United States1 site
Arizona School of Dentistry & Oral Health
Mesa, Arizona, 85206
About this study
Official title: Efficacy of GLO Science Professional Teeth Whitening Product Offerings in Adults
This is a 30 day randomized, parallel comparative trial where participants with tooth shade of C2 or darker will be assigned to one of five groups. The participants will be evaluated for the difference in tooth shade, as determined by the digital VITA Easyshade V (provided by GLO) before the respective whitening regimen (baseline), immediately following the treatment period, and at 30 days (~4 weeks) from end of the treatment intervention.
- Conditions
- Tooth Discoloration
- Being tested
- Hydrogen peroxide teeth whitening gel, GLO Brilliant Teeth Whitening Device, GLO Lit Teeth Whitening Device, GLO Science Professional Teeth Whitening Device
- Keywords
- Teeth whitening, Teeth bleaching, Tooth discoloration
- Medical subject headings
- Tooth Discoloration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrogen peroxide teeth whitening gelOther
Hydrogen peroxide teeth whitening gel with concentrations ranging between 6% - 30%
GLO Brilliant Teeth Whitening DeviceDevice
Intra-oral mouthpiece connected to a battery in order to generate light and heat to effect the whitening treatment.
GLO Lit Teeth Whitening DeviceDevice
Intra-oral mouthpiece connected to a battery in order to generate light and heat to effect the whitening treatment.
GLO Science Professional Teeth Whitening DeviceDevice
Intra-oral mouthpiece connected to a battery in order to generate light and heat to effect the whitening treatment.
| Study group | Role | What they receive |
|---|---|---|
| GLO Science Professional Chairside Teeth Whitening | Experimental | Not described Receives: Other: Hydrogen peroxide teeth whitening gel; Device: GLO Science Professional Teeth Whitening Device |
| GLO Science Professional At-Home Teeth Whitening Device | Experimental | Not described Receives: Other: Hydrogen peroxide teeth whitening gel; Device: GLO Science Professional Teeth Whitening Device |
| GLO Brilliant At-Home Teeth Whitening Device | Experimental | Not described Receives: Other: Hydrogen peroxide teeth whitening gel; Device: GLO Brilliant Teeth Whitening Device |
| GLO Lit At-Home Teeth Whitening Device | Experimental | Not described Receives: Other: Hydrogen peroxide teeth whitening gel; Device: GLO Lit Teeth Whitening Device |
| GLO Lit Whitening GLO Vials | Experimental | Not described Receives: Other: Hydrogen peroxide teeth whitening gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tooth whitening efficacy: tooth shade value
Change in tooth shade value as indicated by the digital VITA Easyshade V
Measured: Immediately following treatment period (32 minutes, 5 days or 7 days), and after 30 days
Secondary outcomes (1)
Tooth whitening safety: presence/absence of adverse events
Post-treatment dentinal hypersensitivity and the presence/absence of adverse events
Measured: Immediately following treatment period (32 minutes, 5 days or 7 days), and after 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2019
- Study start1 Sep 2019
- Primary completion30 Nov 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth DiscolorationStudies 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
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glo Science, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Arizona School of Dentistry & Oral Health, A. T. Still University
- Responsible party
- Sponsor
- Investigators
- Ann Spolarich, RDH, PhD, Principal investigator, Arizona School of Dentistry & Oral Health, A. T. Still University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04124068
- Sponsor's protocol ID
- GLO-003
- Status last verified
- Feb 2020
- First submitted
- 10 Oct 2019
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of GLO Science Professional Teeth Whitening Product Offerings in Adults
- ClinicalTrials.gov ID
- NCT04124068
- Acronym / sponsor ID
- GLO-003
- Conditions
- Tooth Discoloration
- Keywords
- Teeth whitening, Teeth bleaching, Tooth discoloration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Glo Science, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Arizona School of Dentistry & Oral Health, A. T. Still University
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 11 Oct 2019 (actual)
- 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.
This is a 30 day randomized, parallel comparative trial where participants with tooth shade of C2 or darker will be assigned to one of five groups. The participants will be evaluated for the difference in tooth shade, as determined by the digital VITA Easyshade V (provided by GLO) before the respective whitening regimen (baseline), immediately following the treatment period, and at 30 days (~4 weeks) from end of the treatment intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| GLO Science Professional Chairside Teeth Whitening | Experimental | Other: Hydrogen peroxide teeth whitening gel, Device: GLO Science Professional Teeth Whitening Device |
| GLO Science Professional At-Home Teeth Whitening Device | Experimental | Other: Hydrogen peroxide teeth whitening gel, Device: GLO Science Professional Teeth Whitening Device |
| GLO Brilliant At-Home Teeth Whitening Device | Experimental | Other: Hydrogen peroxide teeth whitening gel, Device: GLO Brilliant Teeth Whitening Device |
| GLO Lit At-Home Teeth Whitening Device | Experimental | Other: Hydrogen peroxide teeth whitening gel, Device: GLO Lit Teeth Whitening Device |
| GLO Lit Whitening GLO Vials | Experimental | Other: Hydrogen peroxide teeth whitening gel |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Provide written informed consent to participate in the study.
- Be 18 to 65 years of age.
- Agree not to participate in any other oral/dental product studies during the trial.
- Agree to delay any elective dentistry (including dental prophylaxis) until the study has been completed.
- Agree to refrain from the use of any other teeth whitening products once assigned to a treatment group.
Key exclusion criteria (12 listed)
- Are undergoing treatment for gingivitis, periodontitis, or caries.
- Presence of self-reported tooth sensitivity.
- Present with fixed orthodontic appliances on the facial surfaces of the maxillary arch.
- Have dental crowns, veneers or composite restorations on gradable maxillary anterior teeth ( canine to canine) or mandibular anterior teeth.
- Have any oral pathologies or gross neglect of home care requiring prompt treatment, including periodontal disease, as evidenced by purulent exudate, exposed root surfaces (generalized recession), tooth mobility, and/or other signs indicating that the integrity of the data collected for that subject might be compromised.
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 |
|---|---|---|
| Hydrogen peroxide teeth whitening gelHydrogen peroxide teeth whitening gel with concentrations ranging between 6% - 30% | Other | GLO Brilliant At-Home Teeth Whitening Device, GLO Lit At-Home Teeth Whitening Device, GLO Lit Whitening GLO Vials, GLO Science Professional At-Home Teeth Whitening Device, GLO Science Professional Chairside Teeth Whitening |
| GLO Brilliant Teeth Whitening DeviceIntra-oral mouthpiece connected to a battery in order to generate light and heat to effect the whitening treatment. | Device | GLO Brilliant At-Home Teeth Whitening Device |
| GLO Lit Teeth Whitening DeviceIntra-oral mouthpiece connected to a battery in order to generate light and heat to effect the whitening treatment. | Device | GLO Lit At-Home Teeth Whitening Device |
| GLO Science Professional Teeth Whitening DeviceIntra-oral mouthpiece connected to a battery in order to generate light and heat to effect the whitening treatment. | Device | GLO Science Professional At-Home Teeth Whitening Device, GLO Science Professional Chairside Teeth Whitening |
Primary outcome
Tooth whitening efficacy: tooth shade value
Time frame: Immediately following treatment period (32 minutes, 5 days or 7 days), and after 30 days
Change in tooth shade value as indicated by the digital VITA Easyshade V
1 secondary outcome
Tooth whitening safety: presence/absence of adverse events
Time frame: Immediately following treatment period (32 minutes, 5 days or 7 days), and after 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Individual participant dataSharing planned: No
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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.
Ann Spolarich, RDH, PhD principal investigator
Arizona School of Dentistry & Oral Health, A. T. Still University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrogen peroxide teeth whitening gel, GLO Brilliant Teeth Whitening Device and GLO Lit Teeth Whitening Device in people with Tooth Discoloration, run by Glo Science, Inc. at 1 site in United States.
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 11 inclusion and 12 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: finished, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Tooth whitening efficacy: tooth shade value (time frame: Immediately following treatment period (32 minutes, 5 days or 7 days), and after 30 days). 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 5 Feb 2020.