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Adjunctive Hydrogen Peroxide for Periodontal Therapy

NCT03262701 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2022-12-21

Study results available
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Summary

There have been many adjunctive treatments for the additional clinical benefits to scaling and root planing (SRP) in the treatment of chronic periodontitis. Topical hydrogen peroxide (HP) delivered in a custom fabricated tray has been shown to improve pocket depth (PD) and inflammation. The purpose of this study is to assess the adjunctive treatment outcome of HP gel in custom tray application in individuals with chronic periodontitis receiving SRP. The purpose of this investigator-initiated study is to evaluate and compare the clinical effects of scaling and root planing (SRP) combined with local delivery of 1.7% hydrogen peroxide (HP) gel in customized trays to that of SRP alone.

Conditions

  • Periodontitis, Chronic

Interventions

DRUG

Hydrogen Peroxide Gel, 13 weeks

13 weeks of twice-daily use of custom tray application of 1.7% peroxide gel as an adjunct to scaling and root planing in the treatment of chronic periodontitis.

DRUG

Hydrogen Peroxide Gel, 26 weeks

26 weeks of twice-daily use of custom tray application of 1.7% peroxide gel as an adjunct to scaling and root planing in the treatment of chronic periodontitis.

OTHER

Scaling and Root planing group

Subjects will receive the standard of care which is conventional non-surgical therapy for chronic periodontitis without custom tray application of 1.7% peroxide gel

Sponsors & Collaborators

  • Loma Linda University

    lead OTHER

Principal Investigators

  • Yoon Jeong Kim, DDS · Loma Linda University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-04-02
Primary Completion
2021-02-08
Completion
2021-02-08
FDA Drug
Yes

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 NCT03262701 on ClinicalTrials.gov