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Efficacy of Hydrogen Peroxide Gel on Periodontitis With Diabetes

NCT05669560 · Status: WITHDRAWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL

Last updated 2023-11-22

No results posted yet for this study

Summary

Periodontitis is a chronic infectious disease characterized by loss of tooth supporting periodontal structures and alveolar bone. In the U.S. and worldwide, periodontitis is the major cause of tooth loss in adults.

Type 2 Diabetes mellitus (T2DM) is a complex disease that affects 13-15 million Americans and is associated with a variety of serious complications. T2DM is well established as a strong systemic risk factor for periodontitis. The severity and prevalence of periodontitis is much higher in patients with diabetes. This relationship may be bi-directional.

Conditions

Interventions

COMBINATION_PRODUCT

PerioProtect ™= plastic tray +1.7% hydrogen peroxide

Subjects will receive PerioProtect ™ in adjunct to mechanical therapy. 15minutes, twice a day, for 3 months.

Sponsors & Collaborators

  • Perio Protect LLC

    collaborator INDUSTRY

  • University of Oklahoma

    lead OTHER

Principal Investigators

  • John Dmytryk, DDS, PhD · The University of Oklahoma, College of Dentistry, Division in Periodontics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-20
Primary Completion
2027-05-30
Completion
2027-06-30
FDA Device
Yes

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Entities

Diseases

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 NCT05669560 on ClinicalTrials.gov