Clinical and Microbiologic Outcomes of Adjunctive Antimicrobial Photodynamic Therapy in the Non-surgical and Surgical Treatment of Teeth With Periodontal Disease
Study Details
Study Description
Brief Summary
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: mechanical debridement and adjunctive aPDT
|
Device: mechanical debridement
subjects will receive traditional non-surgical mechanical debridement of tooth surfaces with scalers and ultrasonics removing supragingival and subgingival plaque
Device: adjunctive aPDT
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.
|
| Active Comparator: mechanical debridement and sham aPDT
|
Device: mechanical debridement
subjects will receive traditional non-surgical mechanical debridement of tooth surfaces with scalers and ultrasonics removing supragingival and subgingival plaque
Device: sham aPDT
subjects will receive saline and non-light emitting laser on the tooth
|
Outcome Measures
Primary Outcome Measures
- Change in number of bleeding sites (Bleeding On Probing) [baseline, at the re-evaluation appointment(4 to 6 weeks after baseline), and 3 months after the osseous surgery]
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.
- Change in probing depth (Periodontal pocket depth ) [baseline, at the re-evaluation appointment (4 to 6 weeks after baseline), and 3 months after the osseous surgery]
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
Secondary Outcome Measures
- change in microbiologic profile of plaque [baseline, at the re-evaluation appointment(4 to 6 weeks after baseline), and 3 months after the osseous surgery]
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.
- change in microbiologic profile of gingival crevicular fluid(GCF) [baseline, at the re-evaluation appointment(4 to 6 weeks after baseline), and 3 months after the osseous surgery]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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One pocket on each side of the mouth (split design)
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Single rooted tooth
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Pocket depths measured greater than 4mm with bleeding on probing
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Horizontal bone loss
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No furcation involvement
Exclusion Criteria:
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current heavy smokers (>10 cigarettes/day)
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have uncontrolled diabetes (HbA1c ≥ 6.5%)
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other uncontrolled systemic diseases that may comprise healing, such as Vitamin C deficiency, any neutrophil deficiencies, immunodeficiency syndromes, or leukemia
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taking antibiotics within 3 months before the procedure
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vertical bone defects that requires surgical regenerative treatment.
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Pregnancy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The University of Texas Health Science Center at Houston | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- The University of Texas Health Science Center, Houston
Investigators
- Principal Investigator: Shreena P Bhakta, DDS, The University of Texas Health Science Center, Houston
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HSC-DB-21-0998