Trial | NCT03196648  Report issue

Title

Randomized Trial of a Gum Health Formulation
A Randomized Trial Evaluating the Efficacy of a Gum Health Formulation on Gingival Inflammation, Oral Malodor and Tooth Whitening

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    39
The purpose of this study is to evaluate the safety and efficacy of a newly formulated foaming gel product on gingivitis and/or moderate periodontitis when used with or without the GLO Science accelerating device (GLO Device), compared to standard tooth brushing with antioxidant whitening toothpaste with or without flossing (split mouth design for control group).

This is a 60-day randomized single blinded parallel group study. After 42 days, all use of interventional products were discontinued, and the participants returned to the clinical center at day 60 for final measurements. The primary outcomes assessed in this study were the differences in gingival index (GI) and bleeding on probing (BOP) from baseline to 42 & 60 days. The secondary outcomes are tooth whitening, oral malodor, pocket depth and plaque amount.

It is hypothesized that participants using the gingival health product with the GLO Device will experience greater reductions in GI & BOP measurements than the control group, as well as participants using the gingival health product on a toothbrush alone.
Study Started
May 01
2015
Primary Completion
Nov 30
2016
Study Completion
Nov 30
2016
Last Update
Jun 23
2017

Other Gingival health formulation in an accelerating device

The intervention is a gingival health formulation for soft tissue maintenance, oral malodor and gentle teeth whitening to be used with the GLO Science Device

  • Other names: ECO Balance, GLO Science accelerating device

Other Gingival health formulation on a toothbrush

The intervention is a gingival health formulation for soft tissue maintenance, oral malodor and gentle teeth whitening to be used on a toothbrush together with toothpaste.

  • Other names: ECO Balance

Other OTC fluoride toothpaste [sodium fluoride (18F), monofluorophosphate]

OTC anti-cavity toothpaste containing fluoride and sodium monofluorophosphate.

  • Other names: GLO Science Antioxidant Toothpaste

Gingival health formulation in accelerating device Experimental

The interventional gingival health formulation is applied to the participant's mouth by means of an intra-oral accelerating device for a single eight-minute application, daily. Participants were instructed to brush their teeth with an OTC toothpaste twice daily, morning and night.

Gingival health formulation on a toothbrush Experimental

The interventional gingival health formulation is applied to the participant's mouth by means of a toothbrush and OTC toothpaste, together with the formulation in equal amounts, for two-minute applications twice daily, morning and night.

Control group (Split mouth design) Active Comparator

The control group did not receive the interventional gingival health formulation. Participants were instructed to brush their teeth with a toothbrush and OTC toothpaste twice daily, morning and night. In addition, participants were instructed to floss only half of their mouth daily, having the non-flossed half serve as an untreated comparative control of toothbrushing alone.

Criteria 

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 55 years of age
Male or female
Minimum of 20 teeth, excluding crowns and third molar teeth
Mean whole mouth Gingival Index >/=2.0 at baseline; sites with </=7mm pocket depth
Willing to abstain from all oral hygiene procedures 12-18 hours prior to clinical visits
Willing to abstain from eating and drinking for 2 hours prior to clinical visits, only drinking water is allowed
Willing to abstain from chewing gums, oral whitening products, mouthwashes and tobacco products for the study duration
Able to understand and follow study directions

Exclusion Criteria:

Chronic use of photosensitizing medications including NSAIDs, antidepressants, antibiotics and beta-blockers
Diagnosed with diabetes
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 requiring immediate treatment
Patients with severe internal (tetracycline stains) and external discoloration (fluorosis)
Patients with severe chronic periodontitis, aggressive periodontitis, acute necrotizing ulcerative gingivitis, or generalized gingival recession >2mm as evidenced by clinical oral exam
Pregnant or breast-feeding women
Allergy to home bleaching products such as hydrogen peroxide and carbide peroxide
Use of antibiotics within 3 months of enrollment
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 medication 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. Use of low dose of ASA (<325mg) is permitted.
Medical condition which requires pre-medication prior to dental visits/procedures
Current smoking and former smoking within one year of enrollment
No Results Posted