Wound HealNCT05282615
Impact of Daily Use of The Emanate Tray Adjunct to Full Mouth Debridement Compared to Full Mouth Debridement Alone
A study testing Emanate Tray in people with Wound Heal and Mouth; Wound, run by Emanate Biomedical Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound Heal, Mouth; Wound, Periodontal Inflammation
- What is being tested?
- Emanate Tray
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2022to 18 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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).
Who cannot join
- 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.
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- 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
- 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
- Serum creatinine levels equal to > 2 times the upper limit of normal
- 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.).
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Wound Heal, Mouth; Wound, Periodontal Inflammation
- Being tested
- Emanate Tray
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emanate TrayDevice
Emanate Tray, a personalized dental tray set (upper and lower) with PVA hydrogel containing 0.05% w/w chlorhexidine gluconate
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group (Emanate Tray) | Experimental | Full mouth periodontal debridement + Emanate Tray (treatment group) Receives: Device: Emanate Tray |
| Control Group | No intervention | Full mouth periodontal debridement alone (control group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 56 days
Secondary outcomes (4)
To evaluate the primary efficacy-effect of Emanate Tray on bleeding and probing (BOP)
The % reduction in sites with BOP
Measured: 56 days
To evaluate the effect of Emanate Tray on pocket depth (PD) reduction
The mean reduction in pocket depth at Day 56.
Measured: 56 days
To evaluate the effect of Emanate Tray on clinical attachment level (CAL)
The mean reduction in clinical attachment level at Day 56.
Measured: 56 days
To evaluate changes in plaque index (PI)
The mean reduction in amount of plaque at Day 56.
Measured: 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start1 Feb 2022
- Primary completion18 Jan 2023
- Study completion18 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emanate Biomedical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05282615
- Sponsor's protocol ID
- Emanate Tray 001
- Status last verified
- Feb 2023
- First submitted
- 16 Feb 2022
- Last updated
- 2 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05282615
- Acronym / sponsor ID
- Emanate Tray 001
- Conditions
- Wound Heal, Mouth; Wound, Periodontal Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Emanate Biomedical Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 18 Jan 2023 (actual)
- Study completion
- 18 Jan 2023 (actual)
- First posted
- 16 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group (Emanate Tray) | Experimental | Device: Emanate TrayFull mouth periodontal debridement + Emanate Tray (treatment group) |
| Control Group | No intervention | –Full mouth periodontal debridement alone (control group) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emanate TrayEmanate Tray, a personalized dental tray set (upper and lower) with PVA hydrogel containing 0.05% w/w chlorhexidine gluconate | Device | Treatment Group (Emanate Tray) |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: 56 days
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).
4 secondary outcomes
To evaluate the primary efficacy-effect of Emanate Tray on bleeding and probing (BOP)
Time frame: 56 days
To evaluate the effect of Emanate Tray on pocket depth (PD) reduction
Time frame: 56 days
To evaluate the effect of Emanate Tray on clinical attachment level (CAL)
Time frame: 56 days
To evaluate changes in plaque index (PI)
Time frame: 56 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emanate Tray in people with Wound Heal and Mouth; Wound, run by Emanate Biomedical Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (time frame: 56 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2023.