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Perio. Maint. With Diode LBR

Primary Purpose

Chronic Periodontitis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Epic Diode
HP
Sham
Sponsored by
Biolase Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Periodontitis

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Stephen John, DDS

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Sham Comparator

Experimental

Experimental

Experimental

Arm Label

Perio maint. then sham laser

Perio maint. then medicament

Perio maint. then diode laser 1

Perio maint. then diode laser 2

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Incidence of adverse events
Monitoring of patient acceptance of the adjunctive treatment and monitoring of adverse events.

Full Information

First Posted
March 2, 2022
Last Updated
April 28, 2023
Sponsor
Biolase Inc
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1. Study Identification

Unique Protocol Identification Number
NCT05276817
Brief Title
Perio. Maint. With Diode LBR
Official Title
Microbiological Evaluation of Diode Laser Bacterial Reduction as Adjunct to Periodontal Maintenance Treatment: A Pilot Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
October 1, 2022 (Actual)
Study Completion Date
December 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biolase Inc

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Split mouth study. For each patient, each quadrant is assigned to a randomized treatment. 4 treatment arms.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Perio maint. then sham laser
Arm Type
Sham Comparator
Arm Title
Perio maint. then medicament
Arm Type
Experimental
Arm Title
Perio maint. then diode laser 1
Arm Type
Experimental
Arm Title
Perio maint. then diode laser 2
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Epic Diode
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
HP
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham
Intervention Description
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.
Primary Outcome Measure Information:
Title
Bacteria concentration measured by qPCR
Description
Change in levels of the total bacterial load and of individual bacteria from baseline and compared to control.
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Incidence of adverse events
Description
Monitoring of patient acceptance of the adjunctive treatment and monitoring of adverse events.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Stephen John, DDS
City
San Mateo
State/Province
California
ZIP/Postal Code
94402
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Perio. Maint. With Diode LBR

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