Phase 4
Completed N=56
Clinical and Microbiologic Outcomes of aPDT in the Non-surgical Treatment of Implant Inflammation
DENT IMPLANTS · LASER
Source: ClinicalTrials.gov NCT04187053 ↗
Enrolled (actual)
56
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcomePrimary: Mean Probing Pocket Depth — 4.62; 4.45 millimeters
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Probing Pocket Depth |
4.02; 3.63 | — |
| PRIMARY Improvement in Sites as Indicated by Reduction in Inflammation as Assessed by Clinical Attachment Loss |
— | — |
| PRIMARY Number of Bleeding Sites Per Participant as Assessed by Bleeding on Probing |
3.2; 2.51 | — |
| PRIMARY Number of Sites With Plaque Per Participant |
3.13; 3.12 | — |
| PRIMARY Max Probing Pocket Depth |
5.53; 4.76 | — |
| SECONDARY Alpha Diversity as Indicated by Analysis of 16S rRNA Gene Data From Plaque Samples |
105.11; 88.68 | — |
| SECONDARY Levels of Immunologic Biomarkers in Peri-implant Sulcular Fluid (PISF) Sample as Assessed by Multiplexed Fluorescent Bead-based Immunoassay |
97.91; 94.97; 444.11; 177.13; 24.43; 25.33 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04187053). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.