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Efficacy of Teeth Whitening Product Offerings in Adults

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ClinicalTrials.gov Identifier: NCT04124068
Recruitment Status : Active, not recruiting
First Posted : October 11, 2019
Last Update Posted : October 23, 2019
Sponsor:
Collaborator:
Arizona School of Dentistry & Oral Health, A. T. Still University
Information provided by (Responsible Party):
Glo Science, Inc.

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.

Condition or disease Intervention/treatment Phase
Tooth Discoloration Other: Hydrogen peroxide teeth whitening gel Device: GLO Brilliant Teeth Whitening Device Device: GLO Lit Teeth Whitening Device Device: GLO Science Professional Teeth Whitening Device Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of GLO Science Professional Teeth Whitening Product Offerings in Adults
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : November 30, 2019

Arm Intervention/treatment
Experimental: GLO Science Professional Chairside Teeth Whitening Other: Hydrogen peroxide teeth whitening gel
Hydrogen peroxide teeth whitening gel with concentrations ranging between 6% - 30%

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.

Experimental: GLO Science Professional At-Home Teeth Whitening Device Other: Hydrogen peroxide teeth whitening gel
Hydrogen peroxide teeth whitening gel with concentrations ranging between 6% - 30%

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.

Experimental: GLO Brilliant At-Home Teeth Whitening Device 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.

Experimental: GLO Lit At-Home Teeth Whitening Device Other: Hydrogen peroxide teeth whitening gel
Hydrogen peroxide teeth whitening gel with concentrations ranging between 6% - 30%

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.

Experimental: GLO Lit Whitening GLO Vials Other: Hydrogen peroxide teeth whitening gel
Hydrogen peroxide teeth whitening gel with concentrations ranging between 6% - 30%




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04124068


Locations
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United States, Arizona
Arizona School of Dentistry & Oral Health
Mesa, Arizona, United States, 85206
Sponsors and Collaborators
Glo Science, Inc.
Arizona School of Dentistry & Oral Health, A. T. Still University
Investigators
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Principal Investigator: Ann Spolarich, RDH, PhD Arizona School of Dentistry & Oral Health, A. T. Still University

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Responsible Party: Glo Science, Inc.
ClinicalTrials.gov Identifier: NCT04124068     History of Changes
Other Study ID Numbers: GLO-003
First Posted: October 11, 2019    Key Record Dates
Last Update Posted: October 23, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Keywords provided by Glo Science, Inc.:
Teeth whitening
Teeth bleaching
Tooth discoloration
Additional relevant MeSH terms:
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Tooth Discoloration
Tooth Diseases
Stomatognathic Diseases
Hydrogen Peroxide
Anti-Infective Agents, Local
Anti-Infective Agents