Clinical Trial of PeriZone PerioPatch in Subjects With Chronic Periodontitis

NCT01808703 | Unknown

• 2 other identifiers: PZ12-02MIS Implant Technologies Ltd.
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Periodontitis; Periodontal pocket; Periodontal diseases

Outcome Measures

Primary Outcomes (1)

• Change in pocket depth (PD)from Baseline

  PD will be measured from the free gingival margin to the base of the pocket and will be recorded in whole millimeters (mm). If a PD reading falls between two millimeter readings, the rule shall be to round down and the lower of the two readings will be recorded. All sites with PD of 5 mm or more will have two PD readings recorded (multiple-pass probing measurements) per examination time point. The average of the two PD readings will be the basis for deciding whether the site qualifies for treatment (average of two PD readings of 6 mm or more) at Baseline and the response to treatment (Weeks 4, 8 and 12).

  At 4, 8 and 12 weeks

Secondary Outcomes (4)

• Change in clinical attachment level (CAL) from Baseline

  At 4, 8 and 12 weeks

• Change in percent bleeding on probing (BOP) from Baseline

  At 4, 8 and 12 weeks

• Change in Gingival Index (GI) from Baseline

  At 4, 8 and 12 weeks

• Change in Plaque Index (PI) from Baseline

  At 4, 8 and 12 weeks

Study Arms (2)

Scaling and root planing plus PerioPatch

EXPERIMENTAL

All subjects in this group will receive scaling and root planing (full mouth during no more than 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. Subjects will apply study patches (i.e., BID on Days 1, 28 and 42; QD on Days 2-6; Days 14-20, 29-30 and 43-44) to designated "treatment sites" (i.e., measuring 6 mm or more in pocket depth at Baseline).

Device: PeriZone PerioPatch; Procedure: Scaling and root planing alone

Scaling and root planing alone

ACTIVE COMPARATOR

Subjects in this group will receive only scaling and root planing (full mouth during no more than 2 sessions within two weeks following the Baseline exam).

Procedure: Scaling and root planing alone

Interventions

PeriZone PerioPatch DEVICE

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).

Scaling and root planing plus PerioPatch

Scaling and root planing alone PROCEDURE

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.

Scaling and root planing alone; Scaling and root planing plus PerioPatch

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult males or females 18 years or older
• Able and willing to follow study procedures and instructions
• Must have read, understood and signed an informed consent form
• Present with at least 12 teeth in the functional dentition, excluding third molars
• Generalized, moderate to severe chronic periodontitis
• Present with at least two periodontal pockets (on separate teeth) measuring 6 mm or more and that bleed on probing

You may not qualify if:

• Gross oral pathology
• Chronic treatment (i.e., two weeks or more) with anti-inflammatory medications (steroids or nonsteroidal anti-inflammatory drugs) or any other medications known to affect periodontal status (e.g., phenytoin, calcium antagonists, cyclosporine and coumadin) within one month of the screening examination
• Antibiotic treatment within 3 month prior to the screening examination
• History of rheumatic fever, valvular disease, valve replacement or prosthetic joint replacement necessitating antibiotic prophylaxis
• Active infectious diseases such as hepatitis, human immunodeficiency virus (HIV) or tuberculosis
• Reported allergies to herbal products
• Taking herbal product supplements
• Severe unrestored caries or any condition that is likely to require antibiotic treatment over the study
• Periodontal therapy (quadrant or maintenance scaling and root planing and/or periodontal surgical therapy) within 6 months prior to enrollment.
• Female patients who report being pregnant or lactating, or female patients who are of childbearing potential and who are not using hormonal, barrier methods of birth control (e.g., oral or parenteral contraceptives, diaphragm plus spermicide, condoms), or abstinence

Sponsors & Collaborators

• MIS Implant Technologies, Ltd: lead

Study Sites (2)

School of Dentistry, University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599-7450, United States

RECRUITING

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

Norfolk, Virginia, 23529, United States

RECRUITING

MeSH Terms

Conditions

Chronic Periodontitis; Periodontitis; Periodontal Pocket; Periodontal Diseases

Interventions

Tooth Exfoliation; Root Planing

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry

Study Officials

• Rebecca S Wilder, MS

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

• Gayle B McCombs, MS

  Old Dominion University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David W Paquette, DMD, DMSc

CONTACT

(631) 624-5937; david.paquette@stonybrook.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2013
• First Posted: March 11, 2013
• Study Start: March 1, 2013
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: March 11, 2013

Record last verified: 2013-03

Locations

US (2)