CompletedNot Applicable

Randomized Trial of a Gum Health Formulation

United States39 participantsStarted 2015-05-01

Plain-language summary

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.

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Differences in bleeding on probing

Timeframe: Baseline to 42 days

Differences in Gingival Index

Timeframe: Baseline to 42 days

Trial details

NCT IDNCT03196648

SponsorGlo Science, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-11-30

View on ClinicalTrials.gov More Periodontal Diseases trials