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

Periodontal Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02906982
• Other study ID #: GLO-001
• Status: Completed
• Phase: N/A
• First received: September 13, 2016
• Last updated: September 15, 2016
• Start date: October 2015
• Est. completion date: April 2016

Study information

• Verified date: September 2016
• Source: Glo Science, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gingival Diseases
• Gingivitis
• Periodontal Diseases
• Periodontitis
• Tooth Discoloration

Intervention

Other:
• Gum health formulation in intra-oral device
The intervention is a gum health formulation for periodontal disease care and teeth whitening to be used within an accelerating intra-oral device.
• Gum health formulation on toothbrush
The intervention is a gum health formulation for periodontal care and teeth whitening to be used on a toothbrush alongside standard toothpaste.

Locations

Country	Name	City	State
United States	EEC Institute, Inc.	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Glo Science, Inc.	EEC Institute, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Plaque Index	Periodontal probe will be swept along the buccal and lingual surfaces and plaque is noted.	Baseline, Day 14, Day 28, Day 45	No
Secondary	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	No
Secondary	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	No
Secondary	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	No