Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Emanate Biomedical Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
The goal of this clinical trial is to compare safety and to see if individuals with generalized stage III periodontitis that are given a periodontal hydrogel dressing on a wound healing after plaque and tartar have been removed from teeth have greater healing than individuals who are given no treatment after.
Periodontitis can be considered a chronic wound, in which the barrier has been compromised allowing pathogenic bacteria to infiltrate the subgingival space.
In this study, the Emanate Perio PODS dressing is applied for 30 minutes immediately after toothbrushing and interdental cleaning to physically protect the healing periodontal pocket from pathogenic bacteria while the epithelium reestablishes itself; which usually takes between 15-30 minutes. By week four post SRP, the epithelium matures enough to withstand the mechanical forces and therefore the treatment can stop. It is hypothesized that during the initial phases of healing, i.e., day 1 to day 30, and in the absence of mechanical forces, the epithelium can protect the subgingival pocket, and Emanate Perio PODS dressing is only applied after toothbrushing and interdental cleaning when tissue is exposed to disruptive mechanical forces. The limited use of the device minimizes the burden of use on patients and aligns with recommended twice daily toothbrushing which can improve treatment adherence and compliance.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A - 2x/day PODS | Experimental | Emanate Perio PODS used 2x/day for 30 minutes for 15 days post-SRP |
|
| Group B - Control | No Intervention | No treatment post-SRP (Control Group) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Emanate Perio PODS | Device | Emanate Perio PODS used 2x/day for 30 minutes use |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness on periodontal wound healing compared to control as evidenced by the presence/absence of gingival bleeding | Change in Bleeding on Marginal Probing (BOMP) over time at 60 Days post non-surgical therapy | 60 Days post non-surgical therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness on periodontal wound healing compared to control | As evidenced by change in Modified Gingival Index (MGI) | 60 Days post non-surgical therapy |
| Effectiveness on periodontal wound healing compared to control |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness on periodontal wound healing compared to the historical treatment effect of non-surgical therapy | Change in Pocket Depth (PD) over time in sites with baseline pockets >/=4mm at 60 days post non-surgical therapy | 60 Days post non-surgical therapy |
| Feasibility of usage of the Emanate Perio PODS twice a day group |
Inclusion Criteria:
Subjects must meet all the following criteria to be entered into the study:
Exclusion Criteria:
Subjects who meet the above inclusion criteria will be eligible for the study, unless they present with any of the following:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jill Fuqua | Contact | 6159457118 | j.fuqua@themcguireinstitute.org |
| Name | Affiliation | Role |
|---|---|---|
| Jarret Fass | Emanate Biomedical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regenerative Solutions | Recruiting | Fullerton | California | 92835 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a 90-day(including 30 day screening), randomized, examiner-blind, controlled, two-armed, parallel group, multisite clinical trial comparing 2x/day for 30-minutes use of the Emanate Perio PODS post-SRP* over a 15-day treatment period followed by the Standard of Care** (SOC) to investigate the effects of different regiments on safety, tolerability, and periodontal wound healing.
Not provided
Not provided
At each study site, study roles will be designated such that the blinded examiner procedures will be separate from the clinicians conducting the other evaluations
As evidenced by change change in Pocket Depth (PD) over time in sites with baseline pockets >/=4mm
| 60 Days post non-surgical therapy |
Feasibility will be characterized by compliance at Day 15 post non-surgical therapy |
| Day 15 |
| Feasibility of usage of the Emanate Perio PODS twice a day group | Feasibility will be characterized by Dropout rate pre-treatment and at day 15 and Day 30 | Pre-treatment, Day 15, Day 30 |
| Feasibility of usage of the Emanate Perio PODS twice a day group | Feasibility will be characterized by mouthpiece fit and comfort as measured using the VAS at Day 0 and at Day 15 post non-surgical therapy | Pre-treatment, Day 15 |
| Shoreline Periodontics and Dental Implants | Recruiting | New London | Connecticut | 06320 | United States |
|
| The Perio Studio | Recruiting | Boston | Massachusetts | 02108 | United States |
|
| Metro West Orthodontics & Periodontics | Recruiting | La Vista | Nebraska | 68128 | United States |
|
| Perio Health Professionals | Recruiting | Houston | Texas | 77063 | United States |
|
| Perio Health Professionals | Recruiting | Houston | Texas | 77063 | United States |
|
| Periodontal Center of Excellence, PLLC | Recruiting | Spring | Texas | 77380 | United States |
|
| Glazier Implants + Periodontics | Recruiting | Richmond | Virginia | 23226 | United States |
|
| Seattle Periodontist and Implant Dentistry | Not yet recruiting | Seattle | Washington | 98101 | United States |
|
| ID | Term |
|---|---|
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
Not provided
Not provided