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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: Completed Phase 1 study of Chronic Periodontitis, sponsored by Biolase.
NCT05276817 is a Phase 1 study of Chronic Periodontitis that has completed, run by Biolase. The registered enrollment target is 14 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Change in levels of the total bacterial load and of individual bacteria from baseline and compared to control.
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 |
What the finished NCT05276817 record still lists
NCT05276817 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT05276817's enrollment target sits among peer trials
14 1844th of 2000 higher than 154 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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