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Completed

NCT Number: NCT04187053

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

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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Key information

Conditions

DENT IMPLANTS LASER Mouth Diseases Peri-Implantitis Periodontal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Texas Health Science Center at Houston School of Dentistry

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conventional mechanical therapy

Procedure

Both experimental and sham arms will receive the Conventional mechanical therapy

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

Primary outcomes

  1. Mean Probing Pocket Depth

    Time frame: 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.

  2. Mean Probing Pocket Depth

    Time frame: 6 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.

  3. Mean Probing Pocket Depth

    Time frame: 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.

  4. Improvement in Sites as Indicated by Reduction in Inflammation as Assessed by Clinical Attachment Loss

    Time frame: Baseline

  5. Improvement in Sites as Indicated by Reduction in Inflammation as Assessed by Clinical Attachment Loss

    Time frame: 6 weeks post treatment

  6. Improvement in Sites as Indicated by Reduction in Inflammation as Assessed by Clinical Attachment Loss

    Time frame: 12 weeks post treatment

  7. Number of Bleeding Sites Per Participant as Assessed by Bleeding on Probing

    Time frame: 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.

  8. Number of Bleeding Sites Per Participant as Assessed by Bleeding on Probing

    Time frame: 6 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.

  9. Number of Bleeding Sites Per Participant as Assessed by Bleeding on Probing

    Time frame: 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.

  10. Number of Sites With Plaque Per Participant

    Time frame: 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.

  11. Number of Sites With Plaque Per Participant

    Time frame: 6 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.

  12. Number of Sites With Plaque Per Participant

    Time frame: 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.

  13. Max Probing Pocket Depth

    Time frame: 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.

  14. Max Probing Pocket Depth

    Time frame: 6 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.

  15. Max Probing Pocket Depth

    Time frame: 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.

Secondary outcomes

  1. Alpha Diversity as Indicated by Analysis of 16S rRNA Gene Data From Plaque Samples

    Time frame: 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.

  2. Alpha Diversity as Indicated by Analysis of 16S rRNA Gene Data From Plaque Samples

    Time frame: 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.

  3. Levels of Immunologic Biomarkers in Peri-implant Sulcular Fluid (PISF) Sample as Assessed by Multiplexed Fluorescent Bead-based Immunoassay

    Time frame: 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.

  4. Levels of Immunologic Biomarkers in Peri-implant Sulcular Fluid (PISF) Sample as Assessed by Multiplexed Fluorescent Bead-based Immunoassay

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • Academy of Laser Dentistry

Registry information

Official study title

Clinical and Microbiologic Outcomes of Adjunctive Antimicrobial Photodynamic Therapy in the Non-surgical Treatment of Peri-implant Disease

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Dec 5, 2019
Registry last updated
Feb 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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