Perio. Maint. With Diode LBR

Microbiological Evaluation of Diode Laser Bacterial Reduction as Adjunct to Periodontal Maintenance Treatment: A Pilot Clinical Study

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.

Study Overview

• Status: Completed
• Conditions: Chronic Periodontitis
• Intervention / Treatment: Device: Sham; Drug: HP; Device: Epic Diode

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • San Mateo, California, United States, 94402
      • Stephen John, DDS
      • Contact: Stephen John, DDS; Phone Number: 650-571-1900

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Perio maint. then sham laser	Device: Sham; 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.
Experimental: Perio maint. then medicament	Drug: HP; 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.
Experimental: Perio maint. then diode laser 1	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.
Experimental: Perio maint. then diode laser 2	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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events	Monitoring of patient acceptance of the adjunctive treatment and monitoring of adverse events.	3 months

Collaborators and Investigators

• Sponsor: Biolase Inc

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Actual): October 1, 2022
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: March 2, 2022
• First Submitted That Met QC Criteria: March 9, 2022
• First Posted (Actual): March 11, 2022

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: April 28, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Chronic Periodontitis
• Other Study ID Numbers: BIOL-LBR-P-2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes