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

Phase 4

Completed

Conditions: DENT IMPLANTS
LASER

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

Registration Number: NCT04187053

Lead Sponsor: The University of Texas Health Science Center, Houston

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 56

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:

Red, swollen gingival tissues surrounding the implant
Presence of bleeding and/or suppuration on gentle probing around the implant
Increased probing depth compared to probing depth after restoration of the implant (greater than 2mm increase in probing depth)
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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional mechanical therapy with aPDT adjunct	Conventional mechanical therapy	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 with sham aPDT treatment	Saline	Control group will have conventional mechanical instrumentation of implant site with "Sham" aPDT treatment with saline and non-light emitting laser
Conventional mechanical therapy with sham aPDT treatment	Non-light emitting laser	Control group will have conventional mechanical instrumentation of implant site with "Sham" aPDT treatment with saline and non-light emitting laser
Conventional mechanical therapy with aPDT adjunct	Light emitting laser	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 with sham aPDT treatment	Conventional mechanical therapy	Control group will have conventional mechanical instrumentation of implant site with "Sham" aPDT treatment with saline and non-light emitting laser
Conventional mechanical therapy with aPDT adjunct	Methylene Blue	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.

Primary Outcome Measures

Name	Time	Method
Number of Bleeding Sites Per Participant as Assessed by Bleeding on Probing	12 weeks post treatment	Bleeding on probing (BOP) will be assessed, where each of 6 gingival areas (mesiobuccal, mid-buccal, distobuccal, distolingual, mid-lingual, and mesiolingual) around each tooth will be gently swept by the periodontal probe just within the gingival sulcus of the implant and the presence or absence of bleeding will be recorded.
Number of Sites With Plaque Per Participant	12 weeks post treatment	Presence of plaque was evaluated at six sites (mesiobuccal, mid-buccal, distobuccal, distolingual, mid-lingual, and mesiolingual) around the implant surface and the presence of plaque will be recorded.
Max Probing Pocket Depth	12 weeks post treatment	Periodontal pocket depth was measured from the free gingival margin to the base of the pocket, with a UNC periodontal probe with 1mm measurement units. It was assessed at 6 sites per implant: mesiobuccal, mid-buccal, distobuccal, distolingual, mid-lingual, and mesiolingual. For each participant, the depth of the deepest of the 6 sites is reported.
Improvement in Sites as Indicated by Reduction in Inflammation as Assessed by Clinical Attachment Loss	12 weeks post treatment
Mean Probing Pocket Depth	12 weeks post treatment	Periodontal pocket depth was measured from the free gingival margin to the base of the pocket, with a UNC periodontal probe with 1mm measurement units. It was assessed at 6 sites per implant: mesiobuccal, mid-buccal, distobuccal, distolingual, mid-lingual, and mesiolingual. For each participant, an average of the depths of the 6 sites is reported.

Secondary Outcome Measures

Name	Time	Method
Alpha Diversity as Indicated by Analysis of 16S rRNA Gene Data From Plaque Samples	12 weeks post treatment	Plaque samples will be taken from the deepest probing site of each implant at baseline and 12 weeks after aPDT. To assess bacteria in the sample, the V4 region of the 16S rRNA gene will be PCR amplified and sequenced, and 16S rRNA gene data will then be analyzed to determine the alpha diversity of the microbiota community at the implant site. In this study, the minimum alpha diversity is 1 and the maximum is 2501. A higher alpha diversity indicates a higher number of bacterial or taxonomic "units" in the sample.
Levels of Immunologic Biomarkers in Peri-implant Sulcular Fluid (PISF) Sample as Assessed by Multiplexed Fluorescent Bead-based Immunoassay	12 weeks	PISF samples will be taken from six sites of each implant at baseline and 12 weeks after aPDT. The levels of interleukin IL-1a, IL-1b, IL-6, IL-8, IL-10, IL-12, IL-7A, tumor necrosis factor (TNF)-a, C-reactive protein, osteoprotegerin, leptin, and adiponectin will be determined using multiplex proteomic immunoassays.