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Clinical Trial of PeriZone PerioPatch in Subjects With Chronic Periodontitis

NCT01808703 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2013-03-11

No results posted yet for this study

Summary

The purpose of this study is to determine if a topical, adhesive patch (PeriZone PerioPatch) applied to the gums after a deep tooth cleaning (scaling and root planing) reduces the signs of advanced gum disease (chronic periodontitis) more than the deep tooth cleaning alone. Eighty patients with advanced gum disease will be recruited and treated within this clinical trial. Patients will be evaluated for changes in gum measurements over a 12-week period.

Conditions

  • Chronic Periodontitis

Interventions

DEVICE

PeriZone PerioPatch

The PeriZone PerioPatch is an approved barrier or device product intended for the management of all types of oral wounds, injuries and ulcerations of the gingival and oral mucosa (510K number K103054). PerioPatch devices will be applied adjunctively following scaling and root planing).

PROCEDURE

Scaling and root planing alone

Following completion of the Baseline examination, all randomized patients will receive full mouth scaling and root planing at a maximum of two visits within a 14-day time period (Weeks -2 to 0). Use of hand curettes and/or ultrasonic instruments will be permitted. Local or topical anesthesia may be used for patient comfort at the discretion of the clinician performing the scaling and root planing.

Sponsors & Collaborators

  • MIS Implant Technologies, Ltd

    lead INDUSTRY

Principal Investigators

  • Rebecca S Wilder, MS · University of North Carolina, Chapel Hill

  • Gayle B McCombs, MS · Old Dominion University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2013-09-30
Completion
2013-09-30

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 NCT01808703 on ClinicalTrials.gov