Clinical and Microbiologic Outcomes of aPDT in the Non-surgical Treatment of Implant Inflammation

The University of Texas System (UT)

Status and phase: Completed; Phase 4

Conditions: LASER; DENT IMPLANTS

Treatments: Procedure: Conventional mechanical therapy; Device: Light emitting laser; Drug: Methylene Blue; Device: Non-light emitting laser; Drug: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT04187053

HSC-DB-19-0873

Details and patient eligibility

About

The purpose of this study is to compare clinical outcomes (change in bleeding sites (BOP) and probing depth reduction (PPD) after mechanical debridement of implant surfaces at sites exhibiting plaque induced inflammation with or without adjunctive antimicrobial photodynamic therapy (aPDT) and assess the microbiologic profile of plaque samples before and after treatment with or without aPDT samples.

Enrollment: 56 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• at least one implant with peri-implant inflammation that requires non-surgical treatment.
• 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

• current heavy smokers (>10 cigarettes/day)
• have diabetes or other systemic diseases that may comprise healing
• take antibiotics within 3 months before the procedure

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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56 participants in 2 patient groups

Conventional mechanical therapy with aPDT adjunct

Experimental group

Description:

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.

Treatment:

Procedure: Conventional mechanical therapy

Device: Light emitting laser

Drug: Methylene Blue

Conventional mechanical therapy with sham aPDT treatment

Sham Comparator group

Description:

Control group will have conventional mechanical instrumentation of implant site with "Sham" aPDT treatment with saline and non-light emitting laser

Treatment:

Procedure: Conventional mechanical therapy

Device: Non-light emitting laser

Drug: Saline