Perio. Maint. With Diode LBR

Phase 1

Completed

• Conditions: Chronic Periodontitis
• Interventions: Device: Sham; Drug: HP; Device: Epic Diode

• Registration Number: NCT05276817
• Lead Sponsor: Biolase Inc

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-02
• Study First Submitted QC: 2022-03-09
• Study First Posted: 2022-03-11
• Study Start: 2022-04-01
• Primary Completion: 2022-10-01
• Study Completion: 2022-12-01
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-28
• Last Update Posted: 2023-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• • Adults, over 30 years old

  • At least one site in each quadrant having CAL 4-6mm and/or PPD 5-7mm (at least 4 sites per patient) with all adjacent sites having PPD<5mm
  • Patients who received SRP treatment in the past 12 months, who are returning for routine periodontal maintenance debridement, whose pockets are stable at PPD 5-7mm (not showing improvement or decline)

Exclusion Criteria

• • Patients who have had periodontal surgery within 12 months

  • A site adjacent to the potential study site having either an implant placed or a PPD>7mm
  • Patients taking systemic antibiotics or immunosuppressants during or within 3 months of the study
  • Chronic smokers or smokeless tobacco users

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Perio maint. then sham laser	Sham	-
Perio maint. then medicament	HP	-
Perio maint. then diode laser 1	Epic Diode	-
Perio maint. then diode laser 2	Epic Diode	-

Primary Outcome Measures

Name	Time	Method
Bacteria concentration measured by qPCR	1 week	Change in levels of the total bacterial load and of individual bacteria from baseline and compared to control.

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events	3 months	Monitoring of patient acceptance of the adjunctive treatment and monitoring of adverse events.

Trial Locations

Locations (1)

Stephen John, DDS; 🇺🇸 San Mateo, California, United States