- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04124068
Efficacy of Teeth Whitening Product Offerings in Adults
February 4, 2020 updated by: Glo Science, Inc.
Efficacy of GLO Science Professional 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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
75
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arizona
-
Mesa, Arizona, United States, 85206
- Arizona School of Dentistry & Oral Health
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: GLO Science Professional Chairside Teeth Whitening
|
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.
|
EXPERIMENTAL: GLO Science Professional At-Home Teeth Whitening Device
|
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.
|
EXPERIMENTAL: GLO Brilliant At-Home Teeth Whitening Device
|
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.
|
EXPERIMENTAL: GLO Lit At-Home Teeth Whitening Device
|
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.
|
EXPERIMENTAL: GLO Lit Whitening GLO Vials
|
Hydrogen peroxide teeth whitening gel with concentrations ranging between 6% - 30%
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Immediately following treatment period (32 minutes, 5 days or 7 days), and after 30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Immediately following treatment period (32 minutes, 5 days or 7 days), and after 30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ann Spolarich, RDH, PhD, Arizona School of Dentistry & Oral Health, A. T. Still University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 1, 2019
Primary Completion (ACTUAL)
November 30, 2019
Study Completion (ACTUAL)
December 30, 2019
Study Registration Dates
First Submitted
October 10, 2019
First Submitted That Met QC Criteria
October 10, 2019
First Posted (ACTUAL)
October 11, 2019
Study Record Updates
Last Update Posted (ACTUAL)
February 5, 2020
Last Update Submitted That Met QC Criteria
February 4, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GLO-003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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