DENT IMPLANTS, LASER
Conditions
Keywords
Dental implants, Laser, Antimicrobial photodynamic therapy, Low level laser therapy, Peri-implant mucositis, Peri-implantitis
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.
Interventions
PROCEDUREConventional mechanical therapy
Both experimental and sham arms will receive the Conventional mechanical therapy
DRUGSaline
Sham group will receive saline as a sham for methylene blue
DRUGMethylene Blue
Experimental arm will receive methylene blue
DEVICELight emitting laser
Experimental arm will receive Light emitting laser
DEVICENon-light emitting laser
Sham group will receive Non-light emitting laser
Sponsors
Academy of Laser Dentistry
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Sites as Indicated by Reduction in Inflammation as Assessed by Clinical Attachment Loss | Baseline | — |
| Number of Sites With Plaque Per Participant | Baseline | 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 | Baseline | 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. |
| Mean Probing Pocket Depth | Baseline | 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. |
| Number of Bleeding Sites Per Participant as Assessed by Bleeding on Probing | Baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Levels of Immunologic Biomarkers in Peri-implant Sulcular Fluid (PISF) Sample as Assessed by Multiplexed Fluorescent Bead-based Immunoassay | Baseline | 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. |
| Alpha Diversity as Indicated by Analysis of 16S rRNA Gene Data From Plaque Samples | Baseline | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 30 |
| 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 | 26 |
| Total | 56 |
Baseline characteristics
| Characteristic | Total | Conventional Mechanical Therapy With Sham aPDT Treatment | Conventional Mechanical Therapy With aPDT Adjunct |
|---|---|---|---|
| Age, Continuous | 62.82 years STANDARD_DEVIATION 14.17 | 61.03 years STANDARD_DEVIATION 15.16 | 64.36 years STANDARD_DEVIATION 13.32 |
| Dental Arch Mandibular | 19 Participants | 8 Participants | 11 Participants |
| Dental Arch Maxillary | 37 Participants | 18 Participants | 19 Participants |
| Periodontal Diagnosis Edentulous | 6 Participants | 3 Participants | 3 Participants |
| Periodontal Diagnosis Gingivitis | 25 Participants | 10 Participants | 15 Participants |
| Periodontal Diagnosis Periodontitis | 25 Participants | 13 Participants | 12 Participants |
| Position of Implant Anterior | 17 Participants | 11 Participants | 6 Participants |
| Position of Implant Posterior | 39 Participants | 15 Participants | 24 Participants |
| Race and Ethnicity Not Collected | 0 Participants | — | — |
| Region of Enrollment United States | 56 participants | 26 participants | 30 participants |
| Restoration Suprastructure Fixed Partial Denture | 5 Participants | 2 Participants | 3 Participants |
| Restoration Suprastructure Healing Abutment | 2 Participants | 1 Participants | 1 Participants |
| Restoration Suprastructure Overdentures | 5 Participants | 2 Participants | 3 Participants |
| Restoration Suprastructure Single Crown | 44 Participants | 21 Participants | 23 Participants |
| Sex: Female, Male Female | 31 Participants | 13 Participants | 18 Participants |
| Sex: Female, Male Male | 25 Participants | 13 Participants | 12 Participants |
| Width of Buccal Keratinized gingiva | 2.71 millimeters STANDARD_DEVIATION 0.78 | 3.11 millimeters STANDARD_DEVIATION 0.86 | 2.37 millimeters STANDARD_DEVIATION 0.72 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 26 |
| other Total, other adverse events | 0 / 30 | 0 / 26 |
| serious Total, serious adverse events | 0 / 30 | 0 / 26 |
Outcome results
Primary
Improvement in Sites as Indicated by Reduction in Inflammation as Assessed by Clinical Attachment Loss
Time frame: Baseline
Population: Data were not collected for this outcome measure
Primary
Improvement in Sites as Indicated by Reduction in Inflammation as Assessed by Clinical Attachment Loss
Time frame: 6 weeks post treatment
Population: Data were not collected for this outcome measure
Primary
Improvement in Sites as Indicated by Reduction in Inflammation as Assessed by Clinical Attachment Loss
Time frame: 12 weeks post treatment
Population: Data were not collected for this outcome measure
Primary
Max Probing Pocket Depth
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Mechanical Therapy With aPDT Adjunct | Max Probing Pocket Depth | 6.16 millimeters | Standard Deviation 0.75 |
| Conventional Mechanical Therapy With Sham aPDT Treatment | Max Probing Pocket Depth | 6.34 millimeters | Standard Deviation 1.31 |
Primary
Max Probing Pocket Depth
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.
Time frame: 6 weeks post treatment
Population: Data were not collected for 4 participants in the Conventional mechanical therapy with aPDT adjunct arm. Data were not collected for 7 participants in the Conventional mechanical therapy with sham aPDT treatment arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Mechanical Therapy With aPDT Adjunct | Max Probing Pocket Depth | 5.23 millimeters | Standard Deviation 1 |
| Conventional Mechanical Therapy With Sham aPDT Treatment | Max Probing Pocket Depth | 4.16 millimeters | Standard Deviation 1.23 |
Primary
Max Probing Pocket Depth
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.
Time frame: 12 weeks post treatment
Population: Data were not collected for 1 participant in the Conventional mechanical therapy with sham aPDT treatment arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Mechanical Therapy With aPDT Adjunct | Max Probing Pocket Depth | 5.53 millimeters | Standard Deviation 0.95 |
| Conventional Mechanical Therapy With Sham aPDT Treatment | Max Probing Pocket Depth | 4.76 millimeters | Standard Deviation 0.86 |
Primary
Mean Probing Pocket Depth
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.
Time frame: 12 weeks post treatment
Population: Data were not collected for 1 participant in the Conventional mechanical therapy with sham aPDT treatment arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Mechanical Therapy With aPDT Adjunct | Mean Probing Pocket Depth | 4.02 millimeters | Standard Deviation 0.66 |
| Conventional Mechanical Therapy With Sham aPDT Treatment | Mean Probing Pocket Depth | 3.63 millimeters | Standard Deviation 0.59 |
Primary
Mean Probing Pocket Depth
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Mechanical Therapy With aPDT Adjunct | Mean Probing Pocket Depth | 4.62 millimeters | Standard Deviation 0.49 |
| Conventional Mechanical Therapy With Sham aPDT Treatment | Mean Probing Pocket Depth | 4.45 millimeters | Standard Deviation 0.7 |
Primary
Mean Probing Pocket Depth
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.
Time frame: 6 weeks post treatment
Population: Data were not collected for 4 participants in the Conventional mechanical therapy with aPDT adjunct arm. Data were not collected for 7 participants in the Conventional mechanical therapy with sham aPDT treatment arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Mechanical Therapy With aPDT Adjunct | Mean Probing Pocket Depth | 3.92 millimeters | Standard Deviation 0.63 |
| Conventional Mechanical Therapy With Sham aPDT Treatment | Mean Probing Pocket Depth | 3.54 millimeters | Standard Deviation 0.74 |
Primary
Number of Bleeding Sites Per Participant as Assessed by Bleeding on Probing
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Mechanical Therapy With aPDT Adjunct | Number of Bleeding Sites Per Participant as Assessed by Bleeding on Probing | 4.42 Bleeding sites | Standard Deviation 0.85 |
| Conventional Mechanical Therapy With Sham aPDT Treatment | Number of Bleeding Sites Per Participant as Assessed by Bleeding on Probing | 3.53 Bleeding sites | Standard Deviation 0.79 |
Primary
Number of Bleeding Sites Per Participant as Assessed by Bleeding on Probing
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.
Time frame: 6 weeks post treatment
Population: Data were not collected for 4 participants in the Conventional mechanical therapy with aPDT adjunct arm. Data were not collected for 7 participants in the Conventional mechanical therapy with sham aPDT treatment arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Mechanical Therapy With aPDT Adjunct | Number of Bleeding Sites Per Participant as Assessed by Bleeding on Probing | 3.11 Bleeding sites | Standard Deviation 1.21 |
| Conventional Mechanical Therapy With Sham aPDT Treatment | Number of Bleeding Sites Per Participant as Assessed by Bleeding on Probing | 2.13 Bleeding sites | Standard Deviation 1.29 |
Primary
Number of Bleeding Sites Per Participant as Assessed by Bleeding on Probing
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.
Time frame: 12 weeks post treatment
Population: Data were not collected for 1 participant in the Conventional mechanical therapy with sham aPDT treatment arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Mechanical Therapy With aPDT Adjunct | Number of Bleeding Sites Per Participant as Assessed by Bleeding on Probing | 3.2 Bleeding sites | Standard Deviation 0.85 |
| Conventional Mechanical Therapy With Sham aPDT Treatment | Number of Bleeding Sites Per Participant as Assessed by Bleeding on Probing | 2.51 Bleeding sites | Standard Deviation 1.04 |
Primary
Number of Sites With Plaque Per Participant
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Mechanical Therapy With aPDT Adjunct | Number of Sites With Plaque Per Participant | 4.06 sites with plaque | Standard Deviation 0.95 |
| Conventional Mechanical Therapy With Sham aPDT Treatment | Number of Sites With Plaque Per Participant | 4.07 sites with plaque | Standard Deviation 1.06 |
Primary
Number of Sites With Plaque Per Participant
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.
Time frame: 6 weeks post treatment
Population: Data were not collected for 4 participants in the Conventional mechanical therapy with aPDT adjunct arm. Data were not collected for 7 participants in the Conventional mechanical therapy with sham aPDT treatment arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Mechanical Therapy With aPDT Adjunct | Number of Sites With Plaque Per Participant | 3.19 sites with plaque | Standard Deviation 1.42 |
| Conventional Mechanical Therapy With Sham aPDT Treatment | Number of Sites With Plaque Per Participant | 2.86 sites with plaque | Standard Deviation 1.72 |
Primary
Number of Sites With Plaque Per Participant
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.
Time frame: 12 weeks post treatment
Population: Data were not collected for 1 participant in the Conventional mechanical therapy with sham aPDT treatment arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Mechanical Therapy With aPDT Adjunct | Number of Sites With Plaque Per Participant | 3.13 sites with plaque | Standard Deviation 1.07 |
| Conventional Mechanical Therapy With Sham aPDT Treatment | Number of Sites With Plaque Per Participant | 3.12 sites with plaque | Standard Deviation 1.09 |
Secondary
Alpha Diversity as Indicated by Analysis of 16S rRNA Gene Data From Plaque Samples
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.
Time frame: Baseline
Population: Data were not collected for 13 participants in the Conventional mechanical therapy with aPDT adjunct arm. Data were not collected for 10 participants in the Conventional mechanical therapy with sham aPDT treatment arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Mechanical Therapy With aPDT Adjunct | Alpha Diversity as Indicated by Analysis of 16S rRNA Gene Data From Plaque Samples | 100.98 Observed Taxonomic Units (OTUs) | Standard Deviation 22.53 |
| Conventional Mechanical Therapy With Sham aPDT Treatment | Alpha Diversity as Indicated by Analysis of 16S rRNA Gene Data From Plaque Samples | 92.74 Observed Taxonomic Units (OTUs) | Standard Deviation 30.06 |
Secondary
Alpha Diversity as Indicated by Analysis of 16S rRNA Gene Data From Plaque Samples
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.
Time frame: 12 weeks post treatment
Population: Data were not collected for 10 participants in the Conventional mechanical therapy with aPDT adjunct arm. Data were not collected for 11 participants in the Conventional mechanical therapy with sham aPDT treatment arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Mechanical Therapy With aPDT Adjunct | Alpha Diversity as Indicated by Analysis of 16S rRNA Gene Data From Plaque Samples | 105.11 Observed Taxonomic Units (OTUs) | Standard Deviation 29.92 |
| Conventional Mechanical Therapy With Sham aPDT Treatment | Alpha Diversity as Indicated by Analysis of 16S rRNA Gene Data From Plaque Samples | 88.68 Observed Taxonomic Units (OTUs) | Standard Deviation 25.65 |
Secondary
Levels of Immunologic Biomarkers in Peri-implant Sulcular Fluid (PISF) Sample as Assessed by Multiplexed Fluorescent Bead-based Immunoassay
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.
Time frame: Baseline
Population: Samples were not tested for the presence of IL-7A, C-reactive protein, osteoprotegerin, leptin and adiponectin. Data were not collected for 24 participants in the Conventional mechanical therapy with aPDT adjunct arm. Data were not collected for 22 participants in the Conventional mechanical therapy with sham aPDT treatment arm.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Conventional Mechanical Therapy With aPDT Adjunct | Levels of Immunologic Biomarkers in Peri-implant Sulcular Fluid (PISF) Sample as Assessed by Multiplexed Fluorescent Bead-based Immunoassay | IL-6 | 26.05 picograms per milliliter | Standard Deviation 24.1 |
| Conventional Mechanical Therapy With aPDT Adjunct | Levels of Immunologic Biomarkers in Peri-implant Sulcular Fluid (PISF) Sample as Assessed by Multiplexed Fluorescent Bead-based Immunoassay | IL-10 | 3.20 picograms per milliliter | Standard Deviation 1.04 |
| Conventional Mechanical Therapy With aPDT Adjunct | Levels of Immunologic Biomarkers in Peri-implant Sulcular Fluid (PISF) Sample as Assessed by Multiplexed Fluorescent Bead-based Immunoassay | IL-1beta | 391.24 picograms per milliliter | Standard Deviation 451.39 |
| Conventional Mechanical Therapy With aPDT Adjunct | Levels of Immunologic Biomarkers in Peri-implant Sulcular Fluid (PISF) Sample as Assessed by Multiplexed Fluorescent Bead-based Immunoassay | IL-12 | 1.30 picograms per milliliter | Standard Deviation 0.18 |
| Conventional Mechanical Therapy With aPDT Adjunct | Levels of Immunologic Biomarkers in Peri-implant Sulcular Fluid (PISF) Sample as Assessed by Multiplexed Fluorescent Bead-based Immunoassay | IL-8 | 1283.36 picograms per milliliter | Standard Deviation 1094.82 |
| Conventional Mechanical Therapy With aPDT Adjunct | Levels of Immunologic Biomarkers in Peri-implant Sulcular Fluid (PISF) Sample as Assessed by Multiplexed Fluorescent Bead-based Immunoassay | tumor necrosis factor (TNF)-alpha | 4.06 picograms per milliliter | Standard Deviation 2.187 |
| Conventional Mechanical Therapy With aPDT Adjunct | Levels of Immunologic Biomarkers in Peri-implant Sulcular Fluid (PISF) Sample as Assessed by Multiplexed Fluorescent Bead-based Immunoassay | IL-1alpha | 74.13 picograms per milliliter | Standard Deviation 56.69 |
| Conventional Mechanical Therapy With Sham aPDT Treatment | Levels of Immunologic Biomarkers in Peri-implant Sulcular Fluid (PISF) Sample as Assessed by Multiplexed Fluorescent Bead-based Immunoassay | tumor necrosis factor (TNF)-alpha | 3.82 picograms per milliliter | Standard Deviation 1.89 |
| Conventional Mechanical Therapy With Sham aPDT Treatment | Levels of Immunologic Biomarkers in Peri-implant Sulcular Fluid (PISF) Sample as Assessed by Multiplexed Fluorescent Bead-based Immunoassay | IL-1alpha | 42.49 picograms per milliliter | Standard Deviation 5.65 |
| Conventional Mechanical Therapy With Sham aPDT Treatment | Levels of Immunologic Biomarkers in Peri-implant Sulcular Fluid (PISF) Sample as Assessed by Multiplexed Fluorescent Bead-based Immunoassay | IL-1beta | 324.87 picograms per milliliter | Standard Deviation 415.13 |
| Conventional Mechanical Therapy With Sham aPDT Treatment | Levels of Immunologic Biomarkers in Peri-implant Sulcular Fluid (PISF) Sample as Assessed by Multiplexed Fluorescent Bead-based Immunoassay | IL-6 | 39.88 picograms per milliliter | Standard Deviation 58.02 |
| Conventional Mechanical Therapy With Sham aPDT Treatment | Levels of Immunologic Biomarkers in Peri-implant Sulcular Fluid (PISF) Sample as Assessed by Multiplexed Fluorescent Bead-based Immunoassay | IL-8 | 1134.66 picograms per milliliter | Standard Deviation 950.49 |
| Conventional Mechanical Therapy With Sham aPDT Treatment | Levels of Immunologic Biomarkers in Peri-implant Sulcular Fluid (PISF) Sample as Assessed by Multiplexed Fluorescent Bead-based Immunoassay | IL-10 | 2.37 picograms per milliliter | Standard Deviation 1.01 |
| Conventional Mechanical Therapy With Sham aPDT Treatment | Levels of Immunologic Biomarkers in Peri-implant Sulcular Fluid (PISF) Sample as Assessed by Multiplexed Fluorescent Bead-based Immunoassay | IL-12 | 1.37 picograms per milliliter | Standard Deviation 0.28 |
Secondary
Levels of Immunologic Biomarkers in Peri-implant Sulcular Fluid (PISF) Sample as Assessed by Multiplexed Fluorescent Bead-based Immunoassay
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.
Time frame: 12 weeks
Population: Samples were not tested for the presence of IL-7A, C-reactive protein, osteoprotegerin, leptin and adiponectin. Data were not collected for 24 participants in the Conventional mechanical therapy with aPDT adjunct arm. Data were not collected for 22 participants in the Conventional mechanical therapy with sham aPDT treatment arm.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Conventional Mechanical Therapy With aPDT Adjunct | Levels of Immunologic Biomarkers in Peri-implant Sulcular Fluid (PISF) Sample as Assessed by Multiplexed Fluorescent Bead-based Immunoassay | IL-6 | 24.43 picograms per milliliter | Standard Deviation 16.32 |
| Conventional Mechanical Therapy With aPDT Adjunct | Levels of Immunologic Biomarkers in Peri-implant Sulcular Fluid (PISF) Sample as Assessed by Multiplexed Fluorescent Bead-based Immunoassay | IL-10 | 10.65 picograms per milliliter | Standard Deviation 11.28 |
| Conventional Mechanical Therapy With aPDT Adjunct | Levels of Immunologic Biomarkers in Peri-implant Sulcular Fluid (PISF) Sample as Assessed by Multiplexed Fluorescent Bead-based Immunoassay | IL-1beta | 444.11 picograms per milliliter | Standard Deviation 478.65 |
| Conventional Mechanical Therapy With aPDT Adjunct | Levels of Immunologic Biomarkers in Peri-implant Sulcular Fluid (PISF) Sample as Assessed by Multiplexed Fluorescent Bead-based Immunoassay | IL-12 | 1.33 picograms per milliliter | Standard Deviation 0.18 |
| Conventional Mechanical Therapy With aPDT Adjunct | Levels of Immunologic Biomarkers in Peri-implant Sulcular Fluid (PISF) Sample as Assessed by Multiplexed Fluorescent Bead-based Immunoassay | IL-8 | 1691.34 picograms per milliliter | Standard Deviation 1411.79 |
| Conventional Mechanical Therapy With aPDT Adjunct | Levels of Immunologic Biomarkers in Peri-implant Sulcular Fluid (PISF) Sample as Assessed by Multiplexed Fluorescent Bead-based Immunoassay | tumor necrosis factor (TNF)-alpha | 4.53 picograms per milliliter | Standard Deviation 2.46 |
| Conventional Mechanical Therapy With aPDT Adjunct | Levels of Immunologic Biomarkers in Peri-implant Sulcular Fluid (PISF) Sample as Assessed by Multiplexed Fluorescent Bead-based Immunoassay | IL-1alpha | 97.91 picograms per milliliter | Standard Deviation 52.63 |
| Conventional Mechanical Therapy With Sham aPDT Treatment | Levels of Immunologic Biomarkers in Peri-implant Sulcular Fluid (PISF) Sample as Assessed by Multiplexed Fluorescent Bead-based Immunoassay | tumor necrosis factor (TNF)-alpha | 3.52 picograms per milliliter | Standard Deviation 0.46 |
| Conventional Mechanical Therapy With Sham aPDT Treatment | Levels of Immunologic Biomarkers in Peri-implant Sulcular Fluid (PISF) Sample as Assessed by Multiplexed Fluorescent Bead-based Immunoassay | IL-1alpha | 94.97 picograms per milliliter | Standard Deviation 40.14 |
| Conventional Mechanical Therapy With Sham aPDT Treatment | Levels of Immunologic Biomarkers in Peri-implant Sulcular Fluid (PISF) Sample as Assessed by Multiplexed Fluorescent Bead-based Immunoassay | IL-1beta | 177.13 picograms per milliliter | Standard Deviation 174.7 |
| Conventional Mechanical Therapy With Sham aPDT Treatment | Levels of Immunologic Biomarkers in Peri-implant Sulcular Fluid (PISF) Sample as Assessed by Multiplexed Fluorescent Bead-based Immunoassay | IL-6 | 25.33 picograms per milliliter | Standard Deviation 31.99 |
| Conventional Mechanical Therapy With Sham aPDT Treatment | Levels of Immunologic Biomarkers in Peri-implant Sulcular Fluid (PISF) Sample as Assessed by Multiplexed Fluorescent Bead-based Immunoassay | IL-8 | 1478.70 picograms per milliliter | Standard Deviation 1908.61 |
| Conventional Mechanical Therapy With Sham aPDT Treatment | Levels of Immunologic Biomarkers in Peri-implant Sulcular Fluid (PISF) Sample as Assessed by Multiplexed Fluorescent Bead-based Immunoassay | IL-10 | 3.17 picograms per milliliter | Standard Deviation 2.53 |
| Conventional Mechanical Therapy With Sham aPDT Treatment | Levels of Immunologic Biomarkers in Peri-implant Sulcular Fluid (PISF) Sample as Assessed by Multiplexed Fluorescent Bead-based Immunoassay | IL-12 | 1.30 picograms per milliliter | Standard Deviation 0.14 |