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NCT05276817 · ClinicalTrials.gov registry record · Phase 1
Perio. Maint. With Diode LBR
A Phase 1 study of Chronic Periodontitis, sponsored by Biolase.
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
- 1
- Study location
NCT05276817 is a Phase 1 study of Chronic Periodontitis that has completed, run by Biolase. The registered enrollment target is 14 participants. The trial reports 1 study location across 1 state.
The verdict
NCT05276817, a Phase 1 study of Chronic Periodontitis, has completed, sponsored by Biolase.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Conditions Studied
Interventions
- DEVICE Sham
- DEVICE Epic Diode
- DRUG HP
Study Locations (1)
California
- Stephen John, DDS - San Mateo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2022-04-01 |
| Est. Completion | 2022-12-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05276817
The ClinicalTrials.gov registry entry for NCT05276817 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biolase, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Chronic Periodontitis appearing as the primary indexed condition, and to 3 interventions - of which Sham is the first listed.
NCT05276817 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT05276817 about?
NCT05276817 is a clinical study titled "Perio. Maint. With Diode LBR". 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 maintena...
What is the current status of trial NCT05276817?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2022-04-01. Estimated completion is 2022-12-01.
What conditions does trial NCT05276817 study?
This clinical trial studies the following conditions: Chronic Periodontitis.
What interventions are being tested in trial NCT05276817?
The interventions under investigation include: Sham (DEVICE), Epic Diode (DEVICE), HP (DRUG).
Who is sponsoring clinical trial NCT05276817?
This trial is sponsored by Biolase, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05276817 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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