Clinical and Microbiologic Outcomes of aPDT in the Non-surgical Treatment of Implant Inflammation
NCT ID: NCT04187053
Last Updated: 2024-02-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
56 participants
INTERVENTIONAL
2020-02-14
2022-12-06
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
DOUBLE
Study Groups
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Conventional mechanical therapy with aPDT adjunct
Traditional non-surgical mechanical debridement along with antimicrobial photodynamic therapy will be done at implant sites by applying a photosensitizing dye methylene blue (0.1mg/ml) with a disposable syringe from the bottom of pocket in a coronal direction. The dye will be applied topically confined to the epithelialized space surrounding the implant fixture and will not be internalized. After 5 minutes in situ, the surrounding gingival tissues will be irradiated at six sites around the implant 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.
Conventional mechanical therapy
Both experimental and sham arms will receive the Conventional mechanical therapy
Methylene Blue
Experimental arm will receive methylene blue
Light emitting laser
Experimental arm will receive Light emitting laser
Conventional mechanical therapy with sham aPDT treatment
Control group will have conventional mechanical instrumentation of implant site with "Sham" aPDT treatment with saline and non-light emitting laser
Conventional mechanical therapy
Both experimental and sham arms will receive the Conventional mechanical therapy
Saline
Sham group will receive saline as a sham for methylene blue
Non-light emitting laser
Sham group will receive Non-light emitting laser
Interventions
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Conventional mechanical therapy
Both experimental and sham arms will receive the Conventional mechanical therapy
Saline
Sham group will receive saline as a sham for methylene blue
Methylene Blue
Experimental arm will receive methylene blue
Light emitting laser
Experimental arm will receive Light emitting laser
Non-light emitting laser
Sham group will receive Non-light emitting laser
Eligibility Criteria
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Inclusion Criteria
* Peri-implant diseases included are peri-implant mucositis and peri-implantitis
Criteria for diagnosis of peri-implant mucositis or peri-implantitis:
1. Red, swollen gingival tissues surrounding the implant
2. Presence of bleeding and/or suppuration on gentle probing around the implant
3. Increased probing depth compared to probing depth after restoration of the implant (greater than 2mm increase in probing depth)
4. May or may not have progressive bone loss in relation to radiographic bone levels assessed either 1 year following restoration of the implant OR ≥3mm of radiographic bone loss from the implant platform -systemically healthy or with controlled common systemic conditions, such as hypertension, that will not affect wound healing.
Exclusion Criteria
* have diabetes or other systemic diseases that may comprise healing
* take antibiotics within 3 months before the procedure
18 Years
ALL
No
Sponsors
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Academy of Laser Dentistry
OTHER
The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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Jiayin Tan
Periodontics Resident
Principal Investigators
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Jiayin Tan, DDS
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Locations
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University of Texas Health Science Center at Houston School of Dentistry
Houston, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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HSC-DB-19-0873
Identifier Type: -
Identifier Source: org_study_id
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