CClinicalTrials.gg
CompletedNCT04124068Updated Feb 5, 2020

Efficacy of Teeth Whitening Product Offerings in Adults

An interventional study of Hydrogen peroxide teeth whitening gel and GLO Brilliant Teeth Whitening Device in Tooth Discoloration, sponsored by Glo Science, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-05.

Sponsored by Glo Science, Inc. · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Nov 2019, 6 years 10 months ago, and no results have been posted to the registry.
Phase
Not applicable
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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 regimen (baseline), immediately following the treatment period, and at 30 days (\~4 weeks) from end of the treatment intervention.

02

Conditions studied

  • Tooth Discoloration

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Keywords

  • Teeth whitening
  • Teeth bleaching
  • Tooth discoloration
03

In context

Tooth Discoloration

102 studies on the registry are indexed under Tooth Discoloration; 19 are open to participants now.

This study's enrollment of 75 is above the median of 48 across 95 interventional studies indexed under Tooth Discoloration.

Browse Tooth Discoloration studies →

Lead sponsor

Glo Science, Inc. is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.).
  • 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).

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
75 participants (actual)

Study arms

  • Experimental
    GLO Science Professional Chairside Teeth Whitening

    Other: Hydrogen peroxide teeth whitening gel · Device: GLO Science Professional Teeth Whitening Device

  • Experimental
    GLO Science Professional At-Home Teeth Whitening Device

    Other: Hydrogen peroxide teeth whitening gel · Device: GLO Science Professional Teeth Whitening Device

  • Experimental
    GLO Brilliant At-Home Teeth Whitening Device

    Other: Hydrogen peroxide teeth whitening gel · Device: GLO Brilliant Teeth Whitening Device

  • Experimental
    GLO Lit At-Home Teeth Whitening Device

    Other: Hydrogen peroxide teeth whitening gel · Device: GLO Lit Teeth Whitening Device

  • Experimental
    GLO Lit Whitening GLO Vials

    Other: Hydrogen peroxide teeth whitening gel

Interventions

  • OtherHydrogen peroxide teeth whitening gel

    Hydrogen peroxide teeth whitening gel with concentrations ranging between 6% - 30%

  • DeviceGLO Brilliant Teeth Whitening Device

    Intra-oral mouthpiece connected to a battery in order to generate light and heat to effect the whitening treatment.

  • DeviceGLO Lit Teeth Whitening Device

    Intra-oral mouthpiece connected to a battery in order to generate light and heat to effect the whitening treatment.

  • DeviceGLO Science Professional Teeth Whitening Device

    Intra-oral mouthpiece connected to a battery in order to generate light and heat to effect the whitening treatment.

06

What researchers measure

Primary outcomes

  1. Tooth whitening efficacy: tooth shade value

    Change in tooth shade value as indicated by the digital VITA Easyshade V

    Time frame: 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

    Time frame: Immediately following treatment period (32 minutes, 5 days or 7 days), and after 30 days

07

Study locations

1 site
  • Arizona School of Dentistry & Oral Health
    Mesa, Arizona 85206, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04124068
Lead sponsor
Glo Science, Inc.
Collaborators
Arizona School of Dentistry & Oral Health, A. T. Still University
Responsible party
Sponsor
First posted
Oct 11, 2019
Start date
Sep 1, 2019
Primary completion
Nov 30, 2019
Completion
Dec 30, 2019
Last update
Feb 5, 2020

Study contacts

Ann Spolarich, RDH, PhD
principal investigator · Arizona School of Dentistry & Oral Health, A. T. Still University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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