Clinical trial NCT04124068: Efficacy of Teeth Whitening Product Offerings in Adults
Official title: Efficacy of GLO Science Professional Teeth Whitening Product Offerings in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Discoloration
Keywords: Teeth whitening
Teeth bleaching
Tooth discoloration
Lead sponsor: Glo Science, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Arizona School of Dentistry & Oral Health, A. T. Still University
First posted: 2019-10-11
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Tooth whitening efficacy: tooth shade value
timeFrame: Immediately following treatment period (32 minutes, 5 days or 7 days), and after 30 days
Secondary outcomes:
measure: Tooth whitening safety: presence/absence of adverse events
timeFrame: Immediately following treatment period (32 minutes, 5 days or 7 days), and after 30 days
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Arizona School of Dentistry & Oral Health
state: Arizona
Study officials:
affiliation: Arizona School of Dentistry & Oral Health, A. T. Still University
name: Ann Spolarich, RDH, PhD
role: PRINCIPAL_INVESTIGATOR
References: