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NCT04187053 · ClinicalTrials.gov registry record · Phase 4
Clinical and Microbiologic Outcomes of aPDT in the Non-surgical Treatment of Implant Inflammation
A Phase 4 study, sponsored by The University of Texas Health Science Center, Houston.
- Completed
- Registry status
- Phase 4
- Development phase
- 56
- Enrollment target
NCT04187053: Completed Phase 4 study, sponsored by The University of Texas Health Science Center, Houston.
NCT04187053 is a Phase 4 study that has completed, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 56 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04187053, a Phase 4 study, has completed, sponsored by The University of Texas Health Science Center, Houston.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 56 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG Saline
- DRUG Methylene Blue
- PROCEDURE Conventional mechanical therapy
- DEVICE Light emitting laser
- DEVICE Non-light emitting laser
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2020-02-14 |
| Est. Completion | 2022-12-06 |
| Phase | Phase 4 |
What the finished NCT04187053 record still lists
NCT04187053 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 5 interventions - of which Saline is the first listed.
NCT04187053 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04187053 about?
NCT04187053 is a clinical study titled "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...
What is the current status of trial NCT04187053?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 56 participants. The study started on 2020-02-14. Estimated completion is 2022-12-06.
What interventions are being tested in trial NCT04187053?
The interventions under investigation include: Saline (DRUG), Methylene Blue (DRUG), Conventional mechanical therapy (PROCEDURE), Light emitting laser (DEVICE), Non-light emitting laser (DEVICE).
Who is sponsoring clinical trial NCT04187053?
This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04187053's enrollment target sits among peer trials
56 1213th of 2000 higher than 783 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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