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Randomized Trial of a Gum Health Formulation

NCT03196648 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2017-06-23

No results posted yet for this study

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.

Conditions

  • Periodontal Diseases
  • Gingivitis
  • Periodontitis
  • Halitosis

Interventions

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

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

OTC fluoride toothpaste

OTC anti-cavity toothpaste containing fluoride and sodium monofluorophosphate.

Sponsors & Collaborators

  • The Forsyth Institute

    collaborator OTHER

  • Glo Science, Inc.

    lead INDUSTRY

Principal Investigators

  • Hatice Hasturk, DDS, PhD · The Forsyth Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-01
Primary Completion
2016-11-30
Completion
2016-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03196648 on ClinicalTrials.gov