Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy of Teeth Whitening Product Offerings in Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04124068
Recruitment Status : Completed
First Posted : October 11, 2019
Last Update Posted : February 5, 2020
Sponsor:
Collaborator:
Arizona School of Dentistry & Oral Health, A. T. Still University
Information provided by (Responsible Party):
Glo Science, Inc.

Tracking Information
First Submitted Date  ICMJE October 10, 2019
First Posted Date  ICMJE October 11, 2019
Last Update Posted Date February 5, 2020
Actual Study Start Date  ICMJE September 1, 2019
Actual Primary Completion Date November 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 10, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 10, 2019)
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 ]
Post-treatment dentinal hypersensitivity and the presence/absence of adverse events
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Teeth Whitening Product Offerings in Adults
Official Title  ICMJE Efficacy of GLO Science Professional Teeth Whitening Product Offerings in Adults
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Tooth Discoloration
Intervention  ICMJE
  • Other: Hydrogen peroxide teeth whitening gel
    Hydrogen peroxide teeth whitening gel with concentrations ranging between 6% - 30%
  • Device: GLO Brilliant Teeth Whitening Device
    Intra-oral mouthpiece connected to a battery in order to generate light and heat to effect the whitening treatment.
  • Device: GLO Lit Teeth Whitening Device
    Intra-oral mouthpiece connected to a battery in order to generate light and heat to effect the whitening treatment.
  • Device: GLO Science Professional Teeth Whitening Device
    Intra-oral mouthpiece connected to a battery in order to generate light and heat to effect the whitening treatment.
Study Arms  ICMJE
  • Experimental: GLO Science Professional Chairside Teeth Whitening
    Interventions:
    • Other: Hydrogen peroxide teeth whitening gel
    • Device: GLO Science Professional Teeth Whitening Device
  • Experimental: GLO Science Professional At-Home Teeth Whitening Device
    Interventions:
    • Other: Hydrogen peroxide teeth whitening gel
    • Device: GLO Science Professional Teeth Whitening Device
  • Experimental: GLO Brilliant At-Home Teeth Whitening Device
    Interventions:
    • Other: Hydrogen peroxide teeth whitening gel
    • Device: GLO Brilliant Teeth Whitening Device
  • Experimental: GLO Lit At-Home Teeth Whitening Device
    Interventions:
    • Other: Hydrogen peroxide teeth whitening gel
    • Device: GLO Lit Teeth Whitening Device
  • Experimental: GLO Lit Whitening GLO Vials
    Intervention: Other: Hydrogen peroxide teeth whitening gel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 10, 2019)
75
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 30, 2019
Actual Primary Completion Date November 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04124068
Other Study ID Numbers  ICMJE GLO-003
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Glo Science, Inc.
Study Sponsor  ICMJE Glo Science, Inc.
Collaborators  ICMJE Arizona School of Dentistry & Oral Health, A. T. Still University
Investigators  ICMJE
Principal Investigator: Ann Spolarich, RDH, PhD Arizona School of Dentistry & Oral Health, A. T. Still University
PRS Account Glo Science, Inc.
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP