Impact of Daily Use of The Emanate Tray Adjunct to Full Mouth Debridement Compared to Full Mouth Debridement Alone

A Randomized, Controlled, Proof of Concept Trial of the Impact of Daily Use of The Emanate Tray Adjunct to Full Mouth Debridement Compared to Full Mouth Debridement Alone

The study is a 56-day (8-week), randomized, controlled, examiner-blinded, parallel-design study of patients with existing Stage II or Stage III periodontitis. After eligibility determination, subjects will be randomized to the following groups:

• Group 1: Full mouth periodontal debridement + Emanate Tray (treatment group)
• Group 2: Full mouth periodontal debridement alone (control group)

Patients will be evaluated at Baseline and on Days 14, 28, and 56 for primary endpoint and at baseline and on day 56 post-treatment for secondary (efficacy) endpoints.

Study Overview

• Status: Completed
• Conditions: Wound Heal; Periodontal Inflammation; Mouth; Wound
• Intervention / Treatment: Device: Emanate Tray

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Cambridge, Massachusetts, United States, 02142
      • Forsyth Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Provision of signed, written informed consent prior to participation in any study-related procedures.
2. Good general health as evidenced by medical history.
3. At least 18 years of age at time of informed consent signature.
4. Minimum of 18 teeth, excluding third molars.
5. Generalized Stage II-III periodontitis with at least 8 teeth having interproximal clinical attachment level of ≥3 mm and a probing pocket depth of ≥4 mm and ≤7mm, distributed between mandible and 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
6. Having ≥40 percent of sites with bleeding upon probing as a sign of inflammation
7. Willing to use prescribed oral hygiene procedures and products
8. Willingness to maintain their routine dental care
9. Willing to abstain from chewing gums, mouth rinses and whitening products for the study duration.
10. Ability and willingness to attend all study visits and comply with all study visits and all study procedures and requirements.
11. For women with reproductive potential, willingness to use highly effective contraception (e.g., licensed hormonal contraception, intrauterine device, or vasectomy in partner).

Exclusion Criteria:

1. Presence of orthodontic appliances (anterior fixed retainers are allowed as long as the qualifying teeth are not involved).
2. A soft or hard tissue tumor of the oral cavity.
3. Patients with heavy subgingival calculus.
4. Any dental condition that requires immediate treatment, such as carious lesions.
5. Dental implants will be excluded from study, but the patients will not be excluded if they are otherwise eligible
6. Periodontal treatment including SRP within the prior 6 months of enrollment.
7. Participation in any other clinical study within 30 days of screening or during the study.
8. Pregnancy or lactation.
9. Patients that are known to be hypersensitive to chlorhexidine gluconate, glycerin, polyvinyl alcohol, or ethylene vinyl acetate
10. Antibiotic therapy within the last month (30 days)
11. Current smoking (cigarette, cigar, e-cigarette, or marijuana) within 1 year of enrollment
12. Patients that have a history of testing positive for SARS-CoV-2 per patient's report (within last 10 days) or currently having lingering/long-term COVID symptoms.
13. Chronic use (≥3 times/week) of anti-inflammatory medications (e.g., non-steroidal anti inflammatory drugs, steroids). Low-dose aspirin, 81-162 mg is allowed.
14. Immunocompromised subjects (i.e., subjects with AIDS, pulmonary fibrosis, undergoing chemotherapy or radiation treatment etc.).
15. Diabetes Mellitus defined as a HbA1c > 6.5 per laboratory test results
16. Liver function test (aspartate aminotransferase [AST], alanine aminotransferase [ALT], alkaline phosphatase, and total bilirubin) levels equal to > 1.5 times the upper limit of normal
17. Serum creatinine levels equal to > 2 times the upper limit of normal
18. Any medical history or any concomitant medication that might affect the assessment of the study treatment or periodontal tissues, such as nifedipine, phenytoin (Dilantin), or anticoagulant medications (e.g., warfarin [Coumadin] etc.).
19. History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Treatment Group (Emanate Tray); Full mouth periodontal debridement + Emanate Tray (treatment group)	Device: Emanate Tray; Emanate Tray, a personalized dental tray set (upper and lower) with PVA hydrogel containing 0.05% w/w chlorhexidine gluconate
NO_INTERVENTION: Control Group; Full mouth periodontal debridement alone (control group)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Emergent Adverse Events	The number and percentage of subjects who experience at least 1 treatment-emergent AE (TEAE) and the number and percentage of subjects who experience at least 1 TEAE within each specific system organ class (SOC) and preferred term (PT).	56 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the primary efficacy-effect of Emanate Tray on bleeding and probing (BOP)	The % reduction in sites with BOP	56 days
To evaluate the effect of Emanate Tray on pocket depth (PD) reduction	The mean reduction in pocket depth at Day 56.	56 days
To evaluate the effect of Emanate Tray on clinical attachment level (CAL)	The mean reduction in clinical attachment level at Day 56.	56 days
To evaluate changes in plaque index (PI)	The mean reduction in amount of plaque at Day 56.	56 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
To acquire preliminary information regarding the effect of Emanate Tray on inflammatory cytokine levels in gingival crevicular fluid (GCF)	The change in inflammatory mediator levels in GCF at Day 56 compared to baseline.	56 days

Collaborators and Investigators

• Sponsor: Emanate Biomedical Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2022
• Primary Completion (ACTUAL): January 18, 2023
• Study Completion (ACTUAL): January 18, 2023

Study Registration Dates

• First Submitted: February 16, 2022
• First Submitted That Met QC Criteria: March 7, 2022
• First Posted (ACTUAL): March 16, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 2, 2023
• Last Update Submitted That Met QC Criteria: February 1, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation; Wounds and Injuries
• Other Study ID Numbers: Emanate Tray 001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No