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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 56 days
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a combination of thorough teeth cleaning and a special treatment tray for patients with moderate to severe gum disease. The cleaning removes harmful substances, and the tray applies extra treatment directly to the gums.
Eligible Conditions
- Gingivitis
- Wound Healing
- Mouth Ulcer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 56 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~56 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of Treatment-Emergent Adverse Events
Secondary study objectives
To evaluate changes in plaque index (PI)
To evaluate the effect of Emanate Tray on clinical attachment level (CAL)
To evaluate the effect of Emanate Tray on pocket depth (PD) reduction
+1 moreOther study objectives
To acquire preliminary information regarding the effect of Emanate Tray on inflammatory cytokine levels in gingival crevicular fluid (GCF)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Treatment Group (Emanate Tray)Experimental Treatment1 Intervention
Full mouth periodontal debridement + Emanate Tray (treatment group)
Group II: Control GroupActive Control1 Intervention
Full mouth periodontal debridement alone (control group)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Emanate Tray
2022
N/A
~50
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Who is running the clinical trial?
Emanate Biomedical Inc.Lead Sponsor
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