Clinical Trial of PeriZone PerioPatch in Subjects With Chronic Periodontitis

NAUnknownINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

March 31, 2013

Primary Completion Date

September 30, 2013

Study Completion Date

September 30, 2013

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.

Trial Locations (2)

23529

RECRUITING

G. W. Hirschfeld School of Dental Hygiene, Old Dominion University, Norfolk

27599-7450

RECRUITING

School of Dentistry, University of North Carolina at Chapel Hill, Chapel Hill

Sponsors
All Listed Sponsors
lead

MIS Implant Technologies, Ltd

INDUSTRY

NCT01808703 - Clinical Trial of PeriZone PerioPatch in Subjects With Chronic Periodontitis | Biotech Hunter | Biotech Hunter