NCT01808703

Clinical Trial of PeriZone PerioPatch in Subjects With Chronic Periodontitis

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: MIS Implant Technologies, Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Objectives: 1) to evaluate the efficacy of PeriZone PerioPatch (FDA approved device, 510K number K103054) in reducing pocket depth (PD) in subjects with moderate to severe chronic periodontitis; and 2) to assess the effect of PeriZone PerioPatch on secondary clinical outcomes associated with chronic periodontitis including bleeding on probing (BOP), clinical attachment level (CAL), Gingival Index (GI) and Plaque Index (PI). Participants: A total of 80 participants with generalized moderate to severe chronic periodontitis will be recruited for this clinical trial. Trial Design: This study is a multicenter, randomized, single blind, and controlled design trial with two parallel arms. The 2 arms of the study are: * Arm A - Scaling and root planing plus PeriZone PerioPatch; * Arm B - Scaling and root planing alone (control group). Procedures (methods): After potential patients have been screened, informed consent forms are signed, and patients have completed the remaining screening evaluations, each patient will be randomized to a treatment group. Patients must present with generalized, moderate to severe chronic periodontitis defined as having at least two periodontal pockets measuring 6 mm or more and bleeding on probing (at Baseline). Periodontal probing measurements (PD, CAL, GI and PI) will be performed at Baseline (prior to randomization), and at Weeks 4, 8 and 12. All subjects will receive scaling and root planing (full mouth during at most 2 sessions within two weeks following the Baseline exam). Thereafter, PeriZone PerioPatch will be dispensed to subjects per randomization for administration over the trial period (i.e., Days 1-6; Days 14-20; Days 28-30; Days 42-44). Intraoral soft tissue inspection will be performed at Screening, Baseline and at Weeks 4, 8 and 12. Adverse event collection will be performed at Weeks 4, 8 and 12. Compliance will be will be evaluated via collection of unused study devices. Analysis Plan: Baseline and demographic data will be summarized by treatment. Adverse events and safety outcomes will be categorized by treatment and summarized with descriptive statistics. Changes in probing depths, bleeding scores, clinical attachment levels Gingival Index and Plaque Index scores (from Baseline) will be expressed as means per subjects and tested for inter-group differences using nonparametric rank analysis of covariance.

Conditions

• Chronic Periodontitis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-03-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2013-03-11
• Last updated: 2013-03-11

Locations

2 sites across 1 country: United States