Perio. Maint. With Diode LBR

Chronic Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05276817
• Other study ID #: BIOL-LBR-P-2022
• Status: Completed
• Phase: Phase 1
• Start date: April 1, 2022
• Est. completion date: December 1, 2022

Study information

• Verified date: April 2023
• Source: Biolase Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 1, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis

Intervention

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.

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.

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.

Locations

Country	Name	City	State
United States	Stephen John, DDS	San Mateo	California

Sponsors (1)

Lead Sponsor	Collaborator
Biolase Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of adverse events	Monitoring of patient acceptance of the adjunctive treatment and monitoring of adverse events.	3 months