A Phase 1 interventional study of Epic Diode and HP in Chronic Periodontitis, sponsored by Biolase Inc. Completed at 1 site in United States. Open to participants aged 30 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-03.
Sponsored by Biolase Inc · Phase 1, Interventional, and Treatment
The primary aim of this pilot study is to determine whether the test methods described feasibly achieve the goal defined for a future clinical study. The purpose is a quantitative assessment of the bactericidal effect of two adjunctive treatments compared to that of conventional periodontal maintenance debridement. Patients who meet eligibility criteria and are enrolled in the study will receive the standard of care, whole mouth periodontal maintenance treatment using ultrasonic scalers to debride deposits within the gingival sulcus. Subsequently, each of three of the quadrants will be randomly assigned to a test group (keeping the fourth quadrant as the control), thus, a "split-mouth" study design. Microbial samples will be collected using sterile paper points inserted into each tooth site involved in the study at baseline (S1) before test treatment and one week after test treatment (S2). Samples will be analyzed with real time qPCR to identify and quantify specific periodontal pathogens. Data analysis will compare the post-treatment results to baseline, the control treatment arm to the test treatment arm, and the test treatments among each other.
1,635 studies on the registry are indexed under Periodontitis; 327 are open to participants now.
This study's enrollment of 14 is below the median of 45 across 1,191 interventional studies indexed under Periodontitis.
Browse Periodontitis studies →This is the only study on the registry with Biolase Inc as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Adults, over 30 years old
Exclusion Criteria:
Patients who have had periodontal surgery within 12 months
Device: Sham
Drug: HP
Device: Epic Diode
Device: Epic Diode
HP solution will be inserted to the bottom of the periodontal pocket using a disposable side port needle applicator. The diode tip will be inserted into the pocket, parallel with the root surface and moved in slow side to side motions, painting in the full depth and width of the pocket while activating the diode laser.
HP solution will be inserted to the bottom of the periodontal pocket using a disposable side port needle applicator. The solution will be in the pocket for 30 seconds, and then removed using sterile gauze and water spray.
The diode tip will be inserted into the pocket, parallel with the root surface and moved in slow side to side motions, painting in the full depth and width of the pocket. The diode laser will not be activated during the sham treatment. Coe-Pak periodontal dressing will be applied to the control quadrant to isolate it.
Bacteria concentration measured by qPCR
Change in levels of the total bacterial load and of individual bacteria from baseline and compared to control.
Time frame: 1 week
Incidence of adverse events
Monitoring of patient acceptance of the adjunctive treatment and monitoring of adverse events.
Time frame: 3 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.