Clinical trial NCT06914596: A Clinical Trial Comparing Overnight and 2x/Day for 30-minutes Use of the Emanate Perio PODS Post-SRP
Official title: Randomized Controlled Clinical Trial To Assess The Safety and Effectiveness of A Periodontal Hydrogel Dressing (Emanate Perio PODS) On Wound Healing Post-Scaling and Root Planing
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Periodontitis (Stage 3)
Lead sponsor: McGuire Institute
Sponsor class: INDUSTRY
Collaborators: name: Emanate Biomedical Inc.
First posted: 2025-04-06
Enrollment: 111
Sex: ALL
Minimum age (years): 22
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, examiner-blind, controlled, three-armed, parallel group, multi-site clinical trial comparing overnight and 2x/day for 30-minutes use of the Emanate Perio PODS post-SRP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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 and overnight 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.

Eligibility criteria: Inclusion Criteria

1. Subjects will have read, understood, and signed an institutional review board (IRB) approved Informed Consent Form (ICF).
2. Subjects 22 to 75 years of age.
3. Generalized Stage III periodontitis with at least 8 teeth having interproximal clinical attachment level of ≥3 mm and a probing pocket depth of ≥5 mm and ≤7mm, distributed between the mandible and the maxilla, with at least 2 qualifying interproximal sites in each arch. Localized and not more than 6 sites with a PD of 8 mm is acceptable as long as the tooth with 8 mm pocket depth is not clinically diagnosed as hopeless tooth with suppuration or mobility Grade 3 or greater.5-7
4. Subjects have a minimum of 24 natural teeth with a minimum of 2 natural teeth per quadrant excluding third molars.
5. All supragingival accretions can be removed from below the height of contour of the tooth crown to allow for a comprehensive periodontal evaluation and accurate intraoral digital scan of both arches at screening.
6. Subjects agree to refrain from use of oral rinses or dentifrice with known antibacterial properties (e.g., Peridex®, Listerine®, Colgate Total®, Crest Pro-Health®, etc.).
7. Subjects agree to refrain from use of electric flossers or irrigation devices for the duration of the study.
8. Subjects can provide self-care (oral hygiene) without disabilities requiring assistance with daily oral hygiene measures.
9. Subjects are able and willing to follow study procedures and instructions

Exclusion Criteria:

1. Periodontal surgery, implant placement or SRP within 12 months prior to screening or a cleaning/prophylaxis six months prior to screening.
2. Presence of fixed or removable (e.g. Invisalign) orthodontic appliances.
3. Subject with an underlying medical condition which requires antibiotic prophylaxis prior to dental treatment.
4. Subjects with vesiculobullous processes or other similar chronic oral lesions / conditions resulting in gingival irritation, discomfort/pain, or erosions.
5. Subjects with soft or hard tissue tumor(s) of oral cavity.
6. Use of any smoked substances such as tobacco / cannabis including cigarettes, vape, cigars, or use of smokeless tobacco 30 days prior to screening and throughout the study.
7. Uncontrolled medical conditions (e.g., diabetes mellitus, hypertension, cancer).
8. Subjects who are lactating or pregnant or planning to become pregnant through their projected study duration.
9. Subjects taking medications known to affect gingival conditions. (e.g., hyperplasia).
10. Regular, prolonged use of oral antimicrobial rinses 30 days prior to screening or continued anticipated use through their projected study duration.
11. Use of systemic antibiotics 30 days prior to screening or anticipated during the trial period.
12. Subjects taking corticosteroids on a regular basis one week prior to baseline examination and throughout the duration of the study, including oral inhalers.
13. Subjects taking non-steroidal anti-inflammatory (NSAIDS) or other pain medication on a daily basis for more than 3 consecutive days beginning one week prior to the baseline examination and throughout the duration of the study. Subjects are allowed to take 81 mg/day aspirin and may use oral pain medication if needed in the first 48-hours post-SRP period.
14. Subjects taking anticoagulant medications such as warfarin or Plavix or Eliquis.
15. Subjects participating in other clinical studies involving therapeutic intervention (either medical or dental) within 30 days of Screening.
16. Subjects that are known to be hypersensitive to chlorhexidine gluconate, glycerin, polyvinyl alcohol or ethylene vinyl acetate.
17. Subjects, who in the opinion of the investigator, for any reason other than those listed above, will not be able to complete the study per protocol.

Primary outcomes:
measure: Effectiveness on periodontal wound healing compared to control as evidenced by the presence/absence of gingival bleeding
timeFrame: 60 Days post non-surgical therapy
Secondary outcomes:
measure: Effectiveness on periodontal wound healing compared to control
timeFrame: 60 Days post non-surgical therapy
measure: Effectiveness on periodontal wound healing compared to control
timeFrame: 60 Days post non-surgical therapy
Other outcomes:
measure: Effectiveness on periodontal wound healing compared to the historical treatment effect of non-surgical therapy
timeFrame: 60 Days post non-surgical therapy
measure: Feasibility of usage of the Emanate Perio PODS overnight group and the twice a day group
timeFrame: Day 14
measure: Feasibility of usage of the Emanate Perio PODS overnight group and the twice a day group
timeFrame: Pre-treatment, Day 14, Day 30
measure: Feasibility of usage of the Emanate Perio PODS overnight group and the twice a day group
timeFrame: Pre-treatment, Day 14
Locations:
city: Aurora
country: United States
facility: McClain and Schallhorn Periodontics and Implant Dentistry
state: Colorado
city: Aurora
country: United States
facility: McClain and Schallhorn Periodontics and Implant Dentistry
state: Colorado
city: New London
country: United States
facility: Shoreline Periodontics and Dental Implants
state: Connecticut
city: La Vista
country: United States
facility: Metro West Orthodontics & Periodontics
state: Nebraska
city: Houston
country: United States
facility: Perio Health Professionals
state: Texas
city: Victoria
country: United States
facility: Gulf Coast Periodontics
state: Texas
city: Richmond
country: United States
facility: Glazier Implants + Periodontics
state: Virginia
city: Richmond
country: United States
facility: Richardson, Overstreet, & White Ltd.
state: Virginia
Study officials:
affiliation: Emanate Biomedical
name: Jarret Fass
role: STUDY_DIRECTOR
References: