Perio. Maint. With Diode LBR

NCT05276817 | Completed Phase 1 FDA Device

• 1 other identifier: BIOL-LBR-P-2022
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Periodontitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Incidence of adverse events

  3 months

Study Arms (4)

Perio maint. then sham laser

SHAM COMPARATOR

Device: Sham

Perio maint. then medicament

EXPERIMENTAL

Drug: HP

Perio maint. then diode laser 1

EXPERIMENTAL

Device: Epic Diode

Perio maint. then diode laser 2

EXPERIMENTAL

Device: Epic Diode

Interventions

Epic Diode DEVICE

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.

Perio maint. then diode laser 1; Perio maint. then diode laser 2

HP DRUG

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.

Perio maint. then medicament

Sham DEVICE

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.

Perio maint. then sham laser

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Biolase Inc: lead

Study Sites (1)

Stephen John, DDS

San Mateo, California, 94402, United States

Location

MeSH Terms

Conditions

Chronic Periodontitis

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Split mouth study. For each patient, each quadrant is assigned to a randomized treatment. 4 treatment arms.

Study Record Dates

• First Submitted: March 2, 2022
• First Posted: March 11, 2022
• Study Start: April 1, 2022
• Primary Completion: October 1, 2022
• Study Completion: December 1, 2022
• Last Updated: May 3, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)