Efficacy of Teeth Whitening Product Offerings in Adults
Efficacy of GLO Science Professional Teeth Whitening Product Offerings in Adults
1 other identifier
interventional
75
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2019
CompletedFirst Submitted
Initial submission to the registry
October 10, 2019
CompletedFirst Posted
Study publicly available on registry
October 11, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2019
CompletedFebruary 5, 2020
February 1, 2020
3 months
October 10, 2019
February 4, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Tooth whitening efficacy: tooth shade value
Change in tooth shade value as indicated by the digital VITA Easyshade V
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
Immediately following treatment period (32 minutes, 5 days or 7 days), and after 30 days
Study Arms (5)
GLO Science Professional Chairside Teeth Whitening
EXPERIMENTALGLO Science Professional At-Home Teeth Whitening Device
EXPERIMENTALGLO Brilliant At-Home Teeth Whitening Device
EXPERIMENTALGLO Lit At-Home Teeth Whitening Device
EXPERIMENTALGLO Lit Whitening GLO Vials
EXPERIMENTALInterventions
Hydrogen peroxide teeth whitening gel with concentrations ranging between 6% - 30%
Intra-oral mouthpiece connected to a battery in order to generate light and heat to effect the whitening treatment.
Intra-oral mouthpiece connected to a battery in order to generate light and heat to effect the whitening treatment.
Intra-oral mouthpiece connected to a battery in order to generate light and heat to effect the whitening treatment.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Arizona School of Dentistry & Oral Health
Mesa, Arizona, 85206, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ann Spolarich, RDH, PhD
Arizona School of Dentistry & Oral Health, A. T. Still University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 10, 2019
First Posted
October 11, 2019
Study Start
September 1, 2019
Primary Completion
November 30, 2019
Study Completion
December 30, 2019
Last Updated
February 5, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share