Perio. Maint. With Diode LBR

Biolase

Status and phase: Completed; Phase 1

Conditions: Chronic Periodontitis

Treatments: Drug: HP; Device: Sham; Device: Epic Diode

Study type: Interventional

Funder types: Industry

Identifiers

NCT05276817

BIOL-LBR-P-2022

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 30+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 4 patient groups

Perio maint. then sham laser

Sham Comparator group

Treatment:

Device: Sham

Perio maint. then medicament

Experimental group

Treatment:

Drug: HP

Perio maint. then diode laser 1

Experimental group

Treatment:

Device: Epic Diode

Perio maint. then diode laser 2

Experimental group

Treatment:

Device: Epic Diode