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OpenTrials
Completed

NCT Number: NCT04124068

Efficacy of 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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arizona School of Dentistry & Oral Health

Mesa, Arizona, 85206, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hydrogen peroxide teeth whitening gel

Other

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

GLO Brilliant Teeth Whitening Device

Device

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

GLO Lit Teeth Whitening Device

Device

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

GLO Science Professional Teeth Whitening Device

Device

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Glo Science, Inc.

Industry

Collaborators

  • Arizona School of Dentistry & Oral Health, A. T. Still University

Registry information

Official study title

Efficacy of GLO Science Professional Teeth Whitening Product Offerings in Adults

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Oct 11, 2019
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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