Perio. Maint. With Diode LBR

Study Overview
=================
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.

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

Conditions
-----------------
Chronic Periodontitis

Intervention / Treatment
-----------------
* Device: Epic Diode
* Drug: HP
* Device: Sham


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 30 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Perio maint. then sham laser<br> | Device: Sham<br>* 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.<br>|
| Experimental: Perio maint. then medicament<br> | Drug: HP<br>* 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.<br>|
| Experimental: Perio maint. then diode laser 1<br> | Device: Epic Diode<br>* 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.<br>|
| Experimental: Perio maint. then diode laser 2<br> | Device: Epic Diode<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events | Monitoring of patient acceptance of the adjunctive treatment and monitoring of adverse events. | 3 months |