Evaluating the Efficacy of a Gum Health Formulation on Teeth Whitening in Patients With Gingivitis and Periodontitis

Study Overview
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Brief Summary
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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.

Detailed Description
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Over half of the American population suffers from some form of periodontal disease, while millions of Americans are electing for teeth whitening procedures every year. The study is designed to assess the efficacy of a novel gum health formulation on teeth whitening in the context of gingival inflammation. Further, the study aims to assess the efficacy of the novel gum health formulation as an adjunct to the current standard of care in the treatment of gingivitis and periodontitis, depending on the severity of disease. As the dental professional community is whitening teeth in an environment of gingival inflammation, a single product that whitens teeth and controls inflammation is a novel treatment approach and highly desirable among patients and consumers.

Official Title
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A Randomized Trial Evaluating the Efficacy of a Gum Health Formulation on Teeth Whitening in Patients With Gingivitis and Periodontitis

Conditions
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Tooth Discoloration, Periodontal Diseases

Intervention / Treatment
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* Other: Gum health formulation in intra-oral device
* Other: Gum health formulation on toothbrush


Participation Criteria
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Eligibility Criteria
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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 another clinical trial or oral product study Pregnant or breast-feeding women Allergy to home bleaching products such as hydrogen peroxide and carbamide peroxide Use of antibiotics within 3 months of enrolment History of drug use that is associated with gum overgrowth (i.e., Dilantin, nifedipine, etc.) Chronic use of medication such as steroids, anti-coagulant medications, immunosuppressant medications or any other medications or medical conditions that in the opinion of the investigator would interfere with the evaluation or confound interpretation of the study results Medical condition which requires pre-medication prior to dental visits/procedures Smokers Patients who have received quadrant or maintenance scaling & root planing and/or periodontal surgical therapy within 6 months prior to enrolment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gum health formulation in intra-oral device<br>The interventional gum health formulation is applied to the participant's mouth by means of an intra-oral device for a single eight-minute application, daily. Participants instructed to brush their teeth with a toothbrush and toothpaste twice daily, morning and night. | Other: Gum health formulation in intra-oral device<br>* The intervention is a gum health formulation for periodontal disease care and teeth whitening to be used within an accelerating intra-oral device.<br>* Other names: GLO Science intra-oral accelerating device;|
| Experimental: Gum health formulation on toothbrush<br>The interventional gum health formulation is applied to the participant's mouth by means of a toothbrush and toothpaste, plus the gum health formulation, for two-minute applications, twice daily, morning and night. | Other: Gum health formulation on toothbrush<br>* The intervention is a gum health formulation for periodontal care and teeth whitening to be used on a toothbrush alongside standard toothpaste.<br>* Other names: ECO Balance;|
| No Intervention: Control group (split-mouth design)<br>The control group did not receive the interventional gum health formulation. Participants instructed to brush their teeth with a toothbrush and toothpaste twice daily, morning and night. In addition, participants instructed to floss only half of their mouth daily, and the non-flossed half serves as the untreated comparative control receiving no intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Tooth Shade Value over 45 Days | Tooth Shade Value was measured using a Vita Shade Guide and the measurement was transformed to a standardized value. | Baseline, Day 14, Day 28, Day 45 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plaque Index | Periodontal probe will be swept along the buccal and lingual surfaces and plaque is noted. | Baseline, Day 14, Day 28, Day 45 | 
| Gingival Index | Periodontal probe will be placed under the gingival margin and swept along the buccal and lingual surfaces and bleeding is noted. | Baseline, Day 14, Day 28, Day 45 | 
| Bleeding Index | Bleeding will be assessed after probing. A dichotomous scoring system is used at six sites per tooth using one and zero for presence or absence, respectively. | Baseline, Day 14, Day 28, Day 45 | 
| Mean Probing Depth | Pocket depth will be determined with a UNC-15 periodontal probe at six sites per tooth rounded to the next lower whole millimeter. | Baseline, Day 14, Day 28, Day 45 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Periodontal diseases, Periodontitis, Gingivitis, Teeth Whitening, Dental Plaque Index, Periodontal Index, Teeth Whitening Agents, Tooth Discoloration, Mean Probing Depth, Pocket Depth