Evaluating the Efficacy of a Gum Health Formulation on Teeth Whitening in Patients With Gingiviti… (NCT02906982) | Clinical Trial Compass
CompletedNot Applicable
Evaluating the Efficacy of a Gum Health Formulation on Teeth Whitening in Patients With Gingivitis and Periodontitis
United States30 participantsStarted 2015-10
Plain-language summary
The purpose of this study is to evaluate the efficacy of a novel gum health formulation, when used in an intra-oral device or on a toothbrush, for teeth whitening and clinical improvements in periodontal diseases.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
* Willing and able to read, understand and sign an Informed Consent form
* Good general health as evidenced by the medical history
* Between 18 and 65 years of age
* A minimum of 20 teeth, excluding crowns and third molar teeth
* A mean whole mouth Gingival Index score of \>2.0 at baseline
* Sites with \<7mm pocket depth
* Willing to abstain from all oral hygiene procedures for 12-18 hours prior to clinical visits
* Willing to abstain from eating and drinking in the morning of visits, only drinking water
* Willing to abstain from chewing gums, oral whitening products, mouthwashes and tobacco products for the study duration
* Ability to understand and follow study protocol
* No known history of allergy to dairy products or their ingredients, relevant to any ingredient in the test products
Exclusion Criteria:
* Chronic use of photosensitizing medications including NSAIDs, antidepressants, antibiotics and beta blockers
* Diagnosis of diabetes mellitus
* Presence of orthodontic appliances
* Presence of large restorations
* Crown or veneer at the anterior of both upper and lower teeth (including premolar teeth)
* A soft or hard tissue tumor of the oral cavity
* Carious lesions
* Severe internal (tetracycline stains) and external discolouration (fluorosis)
* Diagnosis of severe chronic periodontitis, aggressive periodontitis, acute necrotizing ulcerative gingivitis or generalized gingival recession \>2mm as evidenced by clinical oral exam
* Participating in a…
What they're measuring
1
Change from Baseline Tooth Shade Value over 45 Days