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| Name | Class |
|---|---|
| Academy of Laser Dentistry | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional mechanical therapy with aPDT adjunct | Experimental | 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 | Sham Comparator | Control group will have conventional mechanical instrumentation of implant site with "Sham" aPDT treatment with saline and non-light emitting laser |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional mechanical therapy | Procedure | Both experimental and sham arms will receive the Conventional mechanical therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline |
| 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. | 6 weeks post treatment |
| 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. | 12 weeks post treatment |
| Improvement in Sites as Indicated by Reduction in Inflammation as Assessed by Clinical Attachment Loss | Baseline | |
| Improvement in Sites as Indicated by Reduction in Inflammation as Assessed by Clinical Attachment Loss | 6 weeks post treatment | |
| Improvement in Sites as Indicated by Reduction in Inflammation as Assessed by Clinical Attachment Loss | 12 weeks post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Criteria for diagnosis of peri-implant mucositis or peri-implantitis:
Exclusion Criteria:
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Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Jiayin Tan, DDS | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Health Science Center at Houston School of Dentistry | Houston | Texas | 77030 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 21, 2022 |
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| Saline | Drug | Sham group will receive saline as a sham for methylene blue |
|
| Methylene Blue | Drug | Experimental arm will receive methylene blue |
|
| Light emitting laser | Device | Experimental arm will receive Light emitting laser |
|
| Non-light emitting laser | Device | Sham group will receive Non-light emitting laser |
|
| 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. | Baseline |
| 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. | 6 weeks post treatment |
| 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. | 12 weeks post treatment |
| 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. | Baseline |
| 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. | 6 weeks post treatment |
| 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. | 12 weeks post treatment |
| 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. | Baseline |
| 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. | 6 weeks post treatment |
| 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. | 12 weeks post treatment |
| Baseline |
| 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. | 12 weeks post treatment |
| 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. | Baseline |
| 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. | 12 weeks |
| FG001 | 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 |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Dental Arch | Count of Participants | Participants |
| ||||||||||||||||
| Position of Implant | Count of Participants | Participants |
| ||||||||||||||||
| Restoration Suprastructure | Count of Participants | Participants |
| ||||||||||||||||
| Periodontal Diagnosis | Count of Participants | Participants |
| ||||||||||||||||
| Width of Buccal Keratinized gingiva | Mean | Standard Deviation | millimeters |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | millimeters | Baseline |
|
|
| |||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | millimeters | 6 weeks post treatment |
| ||||||||||||||||||||||||||||||
| 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. | Data were not collected for 1 participant in the Conventional mechanical therapy with sham aPDT treatment arm. | Posted | Mean | Standard Deviation | millimeters | 12 weeks post treatment |
| ||||||||||||||||||||||||||||||
| Primary | Improvement in Sites as Indicated by Reduction in Inflammation as Assessed by Clinical Attachment Loss | Data were not collected for this outcome measure | Posted | Baseline |
| ||||||||||||||||||||||||||||||||||
| Primary | Improvement in Sites as Indicated by Reduction in Inflammation as Assessed by Clinical Attachment Loss | Data were not collected for this outcome measure | Posted | 6 weeks post treatment |
| ||||||||||||||||||||||||||||||||||
| Primary | Improvement in Sites as Indicated by Reduction in Inflammation as Assessed by Clinical Attachment Loss | Data were not collected for this outcome measure | Posted | 12 weeks post treatment |
| ||||||||||||||||||||||||||||||||||
| 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. | Posted | Mean | Standard Deviation | Bleeding sites | Baseline |
| |||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | Bleeding sites | 6 weeks post treatment |
| ||||||||||||||||||||||||||||||
| 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. | Data were not collected for 1 participant in the Conventional mechanical therapy with sham aPDT treatment arm. | Posted | Mean | Standard Deviation | Bleeding sites | 12 weeks post treatment |
| ||||||||||||||||||||||||||||||
| 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. | Posted | Mean | Standard Deviation | sites with plaque | Baseline |
| |||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | sites with plaque | 6 weeks post treatment |
| ||||||||||||||||||||||||||||||
| 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. | Data were not collected for 1 participant in the Conventional mechanical therapy with sham aPDT treatment arm. | Posted | Mean | Standard Deviation | sites with plaque | 12 weeks post treatment |
| ||||||||||||||||||||||||||||||
| 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. | Posted | Mean | Standard Deviation | millimeters | Baseline |
| |||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | millimeters | 6 weeks post treatment |
| ||||||||||||||||||||||||||||||
| 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. | Data were not collected for 1 participant in the Conventional mechanical therapy with sham aPDT treatment arm. | Posted | Mean | Standard Deviation | millimeters | 12 weeks post treatment |
| ||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | Observed Taxonomic Units (OTUs) | Baseline |
| ||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | Observed Taxonomic Units (OTUs) | 12 weeks post treatment |
| ||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | picograms per milliliter | Baseline |
| ||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | picograms per milliliter | 12 weeks |
|
12 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 30 | 0 | 30 | 0 | 30 |
| EG001 | 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 | 0 | 26 | 0 | 26 | 0 | 26 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Srinivas Ayilavarapu, BDS, DSc, MDS | University of Texas Health Science Center at Houston | 713-486-4390 | srinivas.ayilavarapu@uth.tmc.edu |
| Dec 5, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D057873 | Peri-Implantitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| D008751 | Methylene Blue |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D010640 | Phenothiazines |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
|
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|
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|
|
| OG001 | 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 |
|
|
| 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 |
|
|
|
|
|
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
|
|
| OG001 | 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 |
|
|
| OG001 |
| 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 |
|
|
|
|
| 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 |
|
|
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 |
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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
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| OG001 | 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 |
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| 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 |
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| OG001 | 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 |
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| OG001 | 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 |
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| OG001 | 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 |
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| OG001 | 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 |
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