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

NCT05282615 | Completed FDA Device

• 1 other identifier: Emanate Tray 001
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Wound Heal; Mouth; Wound; Periodontal Inflammation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• To evaluate the primary efficacy-effect of Emanate Tray on bleeding and probing (BOP)

  56 days

• To evaluate the effect of Emanate Tray on pocket depth (PD) reduction

  56 days

• To evaluate the effect of Emanate Tray on clinical attachment level (CAL)

  56 days

• To evaluate changes in plaque index (PI)

  56 days

Other Outcomes (1)

• To acquire preliminary information regarding the effect of Emanate Tray on inflammatory cytokine levels in gingival crevicular fluid (GCF)

  56 days

Study Arms (2)

Treatment Group (Emanate Tray)

EXPERIMENTAL

Full mouth periodontal debridement + Emanate Tray (treatment group)

Device: Emanate Tray

Control Group

NO INTERVENTION

Full mouth periodontal debridement alone (control group)

Interventions

Emanate Tray DEVICE

Emanate Tray, a personalized dental tray set (upper and lower) with PVA hydrogel containing 0.05% w/w chlorhexidine gluconate

Treatment Group (Emanate Tray)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed, written informed consent prior to participation in any study-related procedures.
• Good general health as evidenced by medical history.
• At least 18 years of age at time of informed consent signature.
• Minimum of 18 teeth, excluding third molars.
• 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
• Having ≥40 percent of sites with bleeding upon probing as a sign of inflammation
• Willing to use prescribed oral hygiene procedures and products
• Willingness to maintain their routine dental care
• Willing to abstain from chewing gums, mouth rinses and whitening products for the study duration.
• Ability and willingness to attend all study visits and comply with all study visits and all study procedures and requirements.
• For women with reproductive potential, willingness to use highly effective contraception (e.g., licensed hormonal contraception, intrauterine device, or vasectomy in partner).

You may not qualify if:

• Presence of orthodontic appliances (anterior fixed retainers are allowed as long as the qualifying teeth are not involved).
• A soft or hard tissue tumor of the oral cavity.
• Patients with heavy subgingival calculus.
• Any dental condition that requires immediate treatment, such as carious lesions.
• Dental implants will be excluded from study, but the patients will not be excluded if they are otherwise eligible
• Periodontal treatment including SRP within the prior 6 months of enrollment.
• Participation in any other clinical study within 30 days of screening or during the study.
• Pregnancy or lactation.
• Patients that are known to be hypersensitive to chlorhexidine gluconate, glycerin, polyvinyl alcohol, or ethylene vinyl acetate
• Antibiotic therapy within the last month (30 days)
• Current smoking (cigarette, cigar, e-cigarette, or marijuana) within 1 year of enrollment
• 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.
• 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.
• Immunocompromised subjects (i.e., subjects with AIDS, pulmonary fibrosis, undergoing chemotherapy or radiation treatment etc.).
• Diabetes Mellitus defined as a HbA1c \> 6.5 per laboratory test results

Sponsors & Collaborators

• Emanate Biomedical Inc.: lead

Study Sites (1)

Forsyth Institute

Cambridge, Massachusetts, 02142, United States

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2022
• First Posted: March 16, 2022
• Study Start: February 1, 2022
• Primary Completion: January 18, 2023
• Study Completion: January 18, 2023
• Last Updated: February 2, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)