Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2025-12-30 @ 7:41 AM
Study NCT ID:
NCT01808703
Status:
UNKNOWN
Last Update Posted:
2013-03-11
First Post:
2013-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial of PeriZone PerioPatch in Subjects With Chronic Periodontitis
Sponsor:
MIS Implant Technologies, Ltd
Organization:
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2013-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| MIS Implant Technologies Ltd. | OTHER_GRANT | MIS Implant Technologies Ltd. | View |