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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05276817
Study type Interventional
Source Biolase Inc
Contact
Status Completed
Phase Phase 1
Start date April 1, 2022
Completion date December 1, 2022

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