Perio. Maint. With Diode LBR

Sponsor
Biolase Inc (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05276817
Collaborator
(none)
20
1
4
3
6.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Epic Diode
  • Drug: HP
  • Device: Sham
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
Split mouth study. For each patient, each quadrant is assigned to a randomized treatment. 4 treatment arms.Split mouth study. For each patient, each quadrant is assigned to a randomized treatment. 4 treatment arms.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Microbiological Evaluation of Diode Laser Bacterial Reduction as Adjunct to Periodontal Maintenance Treatment: A Pilot Clinical Study
Anticipated Study Start Date :
Mar 1, 2022
Anticipated Primary Completion Date :
May 1, 2022
Anticipated Study Completion Date :
Jun 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Bacteria concentration measured by qPCR [1 week]

    Change in levels of the total bacterial load and of individual bacteria from baseline and compared to control.

Secondary Outcome Measures

  1. Incidence of adverse events [3 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Stephen John, DDS San Mateo California United States 94402

Sponsors and Collaborators

  • Biolase Inc

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Biolase Inc
ClinicalTrials.gov Identifier:
NCT05276817
Other Study ID Numbers:
  • BIOL-LBR-P-2022
First Posted:
Mar 11, 2022
Last Update Posted:
Mar 11, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 11, 2022