Clinical and Microbiologic Outcomes of Adjunctive Antimicrobial Photodynamic Therapy in the Non-surgical and Surgical Treatment of Teeth With Periodontal Disease

Study Overview
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Brief Summary
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The purpose of this study is to compare clinical outcomes after mechanical debridement of at sites exhibiting plaque induced inflammation with or without adjunctive Antimicrobial photodynamic therapy (aPDT) and to assess the the microbiologic profile before and after treatment with or without aPDT

Official Title
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Clinical and Microbiologic Outcomes of Adjunctive Antimicrobial Photodynamic Therapy in the Non-surgical and Surgical Treatment of Teeth With Periodontal Disease

Conditions
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Periodontal Diseases

Intervention / Treatment
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* Device: mechanical debridement
* Device: adjunctive aPDT
* Device: sham aPDT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: One pocket on each side of the mouth (split design) Single rooted tooth Pocket depths measured greater than 4mm with bleeding on probing Horizontal bone loss No furcation involvement Exclusion Criteria: current heavy smokers (>10 cigarettes/day) have uncontrolled diabetes (HbA1c ≥ 6.5%) other uncontrolled systemic diseases that may comprise healing, such as Vitamin C deficiency, any neutrophil deficiencies, immunodeficiency syndromes, or leukemia taking antibiotics within 3 months before the procedure vertical bone defects that requires surgical regenerative treatment. Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mechanical debridement and adjunctive aPDT<br> | Device: mechanical debridement<br>* subjects will receive traditional non-surgical mechanical debridement of tooth surfaces with scalers and ultrasonics removing supragingival and subgingival plaque<br>Device: adjunctive aPDT<br>* Antimicrobial photodynamic therapy will be done at tooth sites by applying a photosensitizing dye methylene blue (0.1mg/ml) with a disposable syringe from the bottom of pocket in a coronal direction. After 3 minutes in situ, the surrounding gingival tissues will be irradiated at six sites around the tooth using a diode laser with a wavelength of 660nm, providing an energy density of 10 J/site, 100mW power, time equal to 100 seconds. After irradiation, the site will be thoroughly rinsed with saline.<br>|
| Active Comparator: mechanical debridement and sham aPDT<br> | Device: mechanical debridement<br>* subjects will receive traditional non-surgical mechanical debridement of tooth surfaces with scalers and ultrasonics removing supragingival and subgingival plaque<br>Device: sham aPDT<br>* subjects will receive saline and non-light emitting laser on the tooth<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in number of bleeding sites (Bleeding On Probing) | Bleeding on probing will be evaluated by gently sweeping the periodontal probe just within the gingival sulcus of the tooth and the presence or absence of bleeding will be recorded. | baseline, at the re-evaluation appointment(4 to 6 weeks after baseline), and 3 months after the osseous surgery | 
| Change in probing depth (Periodontal pocket depth ) | Periodontal pocket depth is measured from the free gingival margin to the base of the pocket, with a UNC periodontal probe with 1mm measurement units | baseline, at the re-evaluation appointment (4 to 6 weeks after baseline), and 3 months after the osseous surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in microbiologic profile of plaque | Plaque sampling will be performed using a curette within the gingival sulcus of the inflamed site. The sample sites will first be isolated by cotton rolls and supragingival and marginal plaque will be removed before subgingival biofilm samples collected using sterile scalers. The collected samples will be immediately placed in separate sterile Eppendorf tubes containing 0.15 ml TE .Samples will be stored at -80 °C until further analysis. | baseline, at the re-evaluation appointment(4 to 6 weeks after baseline), and 3 months after the osseous surgery | 
| change in microbiologic profile of gingival crevicular fluid(GCF) | GCF will be collected from the sulcus around the target tooth using paper strips (PerioPaper, Oraflow). With proper isolation using cotton rolls in the buccal and lingual aspects of the study site, the area will be dried for 5 seconds with compressed air. The paper strip will be gently introduced into the mucosal crevice around the tooth for 30 seconds per site in four sites.The strips will then be removed from the crevice, and the volume of fluid collected in each strip measured using a micromoisture metering device (Peritron, Oraflow). After confirming the adequateness of the volume, the paper strips from each tooth will be transferred into labeled tubes and stored at -80 C for later use. For analysis, the paper strips will be analyzed using multiplexed fluorescent bead-based immunoassay. | baseline, at the re-evaluation appointment(4 to 6 weeks after baseline), and 3 months after the osseous surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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plaque, laser therapy