Actively Recruiting
Randomized Controlled Trial Assessing Safety and Effectiveness of Emanate Perio PODS Hydrogel Dressing on Wound Healing after Scaling and Root Planing
Led by McGuire Institute · Updated on 2026-04-27
72
Participants Needed
9
Research Sites
4 weeks
Total Duration
On this page
Sponsors
M
McGuire Institute
Lead Sponsor
E
Emanate Biomedical Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying individuals with generalized stage III periodontitis to compare the safety and healing effects of a new periodontal hydrogel dressing called Emanate Perio PODS. This device is being evaluated to see if it improves wound healing after plaque and tartar removal from teeth compared to no treatment. The study focuses on the critical healing period following non-surgical periodontal therapy and aims to protect healing tissue from harmful bacteria. The trial involves two groups: one group uses the Emanate Perio PODS device twice daily for 30 minutes each session for 15 days after scaling and root planing (SRP), while the other group receives no additional treatment after SRP. The dressing is applied immediately after toothbrushing and interdental cleaning to shield the healing periodontal pocket during the first 30 days post-treatment, especially during the initial phases when the tissue is vulnerable. Participants will be monitored over 60 days after their non-surgical therapy. Researchers will assess healing by checking for gingival bleeding and other signs of wound repair. The study includes regular periodontal evaluations, intraoral digital scans, and requires participants to follow oral hygiene instructions carefully. The goal is to evaluate the effectiveness and safety of the dressing in supporting tissue healing after SRP with minimal burden on participants.
CONDITIONS
Brief Title
A Clinical Trial Comparing 2x/Day for 30-minutes Use of the Emanate Perio PODS Post-SRP to a Control Group Post-SRP.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects aged 30 to 75 years
- Diagnosed with generalized Stage III periodontitis with at least 8 teeth having clinical attachment level �3 mm and probing pocket depth between 5 mm and 7 mm
- At least 2 qualifying interproximal sites in each arch
- Minimum of 24 natural teeth with at least 2 natural teeth per quadrant, excluding third molars
- Ability to remove all supragingival accretions for periodontal evaluation and intraoral digital scans
- Agreement to avoid oral rinses or dentifrices with antibacterial properties during the study
- Agreement to avoid electric flossers or irrigation devices during the study
- Ability to perform daily oral hygiene without assistance
- Willingness and ability to follow study procedures and instructions
You will not qualify if you...
- Periodontal surgery, implant placement, or scaling and root planing within 12 months prior to screening
- Cleaning or prophylaxis within 3 months prior to screening
- Presence of fixed or removable orthodontic appliances
- Medical conditions requiring antibiotic prophylaxis before dental treatment
- Chronic oral lesions causing gingival irritation or pain
- Oral soft or hard tissue tumors
- Use of smoked substances including tobacco or cannabis within 30 days prior to screening and during the study
- Uncontrolled medical conditions such as diabetes, hypertension, or cancer
- Lactating, pregnant, or planning pregnancy during the study
- Use of medications affecting gingival conditions
- Regular use of oral antimicrobial rinses 30 days prior to screening or anticipated use during the study
- Use of systemic antibiotics 30 days prior to screening or anticipated during the trial
- Regular corticosteroid use one week prior to baseline and during the study
- Daily use of NSAIDs for more than 3 consecutive days starting one week prior to baseline and during the study, except low-dose aspirin
- Use of anticoagulant medications such as warfarin or Plavix
- Participation in other clinical studies involving therapeutic interventions within 30 days of screening
- Known hypersensitivity to chlorhexidine gluconate, glycerin, polyvinyl alcohol, or ethylene vinyl acetate
- Any other condition that would prevent completion of the study as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 15 days post scaling and root planing
Participants use the Emanate Perio PODS device twice daily for 30 minutes after toothbrushing and interdental cleaning to protect the healing periodontal pocket following scaling and root planing.
Twice daily use at home
Duration - Up to 60 days post non-surgical therapy
Participants are monitored to assess periodontal wound healing outcomes following treatment.
1 to 2 follow-up visits (in-person)
Trial Site Locations
Total: 9 locations
1
Regenerative Solutions
Fullerton, California, United States, 92835
Actively Recruiting
2
Shoreline Periodontics and Dental Implants
New London, Connecticut, United States, 06320
Actively Recruiting
3
The Perio Studio
Boston, Massachusetts, United States, 02108
Not Yet Recruiting
4
Metro West Orthodontics & Periodontics
La Vista, Nebraska, United States, 68128
Actively Recruiting
5
Perio Health Professionals
Houston, Texas, United States, 77063
Actively Recruiting
6
Perio Health Professionals
Houston, Texas, United States, 77063
Actively Recruiting
7
Periodontal Center of Excellence, PLLC
Spring, Texas, United States, 77380
Actively Recruiting
8
Glazier Implants + Periodontics
Richmond, Virginia, United States, 23226
Actively Recruiting
9
Seattle Periodontist and Implant Dentistry
Seattle, Washington, United States, 98101
Not Yet Recruiting
Research Team
J
Jill Fuqua
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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