Clinical and Microbiologic Outcomes of Adjunctive Antimicrobial Photodynamic Therapy in the Non-surgical Treatment of Peri-implant Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Number of Bleeding Sites Per Participant as Assessed by Bleeding on Probing
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •current heavy smokers (>10 cigarettes/day)
- •have diabetes or other systemic diseases that may comprise healing
- •take antibiotics within 3 months before the procedure
研究组 & 干预措施
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.
干预措施: Conventional mechanical therapy (Procedure)
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.
干预措施: Methylene Blue (Drug)
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.
干预措施: Light emitting laser (Device)
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
干预措施: Conventional mechanical therapy (Procedure)
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
干预措施: Saline (Drug)
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
干预措施: Non-light emitting laser (Device)
结局指标
主要结局
Number of Bleeding Sites Per Participant as Assessed by Bleeding on Probing
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 12 weeks post treatment
Mean Probing Pocket Depth
时间窗: 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.
次要结局
- Alpha Diversity as Indicated by Analysis of 16S rRNA Gene Data From Plaque Samples(12 weeks post treatment)
- Levels of Immunologic Biomarkers in Peri-implant Sulcular Fluid (PISF) Sample as Assessed by Multiplexed Fluorescent Bead-based Immunoassay(12 weeks)
研究者
Jiayin Tan
Periodontics Resident
The University of Texas Health Science Center, Houston