Clinical and Microbiologic Outcomes of Adjunctive Antimicrobial Photodynamic Therapy in the Non-surgical and Surgical Treatment of Teeth With Periodontal Disease
NCT ID: NCT05252000
Last Updated: 2022-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2022-04-26
2024-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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mechanical debridement and adjunctive aPDT
mechanical debridement
subjects will receive traditional non-surgical mechanical debridement of tooth surfaces with scalers and ultrasonics removing supragingival and subgingival plaque
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.
mechanical debridement and sham aPDT
mechanical debridement
subjects will receive traditional non-surgical mechanical debridement of tooth surfaces with scalers and ultrasonics removing supragingival and subgingival plaque
sham aPDT
subjects will receive saline and non-light emitting laser on the tooth
Interventions
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mechanical debridement
subjects will receive traditional non-surgical mechanical debridement of tooth surfaces with scalers and ultrasonics removing supragingival and subgingival plaque
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.
sham aPDT
subjects will receive saline and non-light emitting laser on the tooth
Eligibility Criteria
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Inclusion Criteria
* Single rooted tooth
* Pocket depths measured greater than 4mm with bleeding on probing
* Horizontal bone loss
* No furcation involvement
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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Shreena Pranav Bhakta
resident
Principal Investigators
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Shreena P Bhakta, DDS
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Locations
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The University of Texas Health Science Center at Houston
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HSC-DB-21-0998
Identifier Type: -
Identifier Source: org_study_id
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