Phase 4 N=56 Randomized Double-blind Treatment

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

DENT IMPLANTS · LASER

Bottom Line

View on ClinicalTrials.gov: NCT04187053 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2023

Primary outcome: Primary: Mean Probing Pocket Depth — 4.62; 4.45 millimeters

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Conventional mechanical therapy (Procedure); Saline (Drug); Methylene Blue (Drug); Light emitting laser (Device); Non-light emitting laser (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: The University of Texas Health Science Center, Houston
Primary completion: Dec 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Probing Pocket Depth	4.02; 3.63	—
PRIMARY Mean Probing Pocket Depth	4.02; 3.63	—
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 Improvement in Sites as Indicated by Reduction in Inflammation as Assessed by Clinical Attachment Loss	—	—
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 Bleeding Sites Per Participant as Assessed by Bleeding on Probing	3.2; 2.51	—
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 Number of Sites With Plaque Per Participant	3.13; 3.12	—
PRIMARY Number of Sites With Plaque Per Participant	3.13; 3.12	—
PRIMARY Max Probing Pocket Depth	5.53; 4.76	—
PRIMARY Max Probing Pocket Depth	5.53; 4.76	—
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 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	—
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	—

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.

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

View full record on ClinicalTrials.gov →

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.