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Methylene Blue for Dental Implants

Phase 4
Waitlist Available
Led By Marcos E Garcia, DDS
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Study Summary

This trial will compare the effects of two different treatments for implant surfaces with plaque-induced inflammation. One treatment will use mechanical debridement with adjunctive antimicrobial photodynamic therapy, and the other will just use mechanical debridement.

Eligible Conditions
  • Dental Implants
  • Laser

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Improvement in Sites as Indicated by Reduction in Inflammation as Assessed by Clinical Attachment Loss
Max Probing Pocket Depth
Mean Probing Pocket Depth
+2 more
Secondary outcome measures
Alpha Diversity as Indicated by Analysis of 16S rRNA Gene Data From Plaque Samples
Levels of Immunologic Biomarkers in Peri-implant Sulcular Fluid (PISF) Sample as Assessed by Multiplexed Fluorescent Bead-based Immunoassay

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Conventional mechanical therapy with aPDT adjunctExperimental Treatment3 Interventions
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.
Group II: Conventional mechanical therapy with sham aPDT treatmentPlacebo Group3 Interventions
Control group will have conventional mechanical instrumentation of implant site with "Sham" aPDT treatment with saline and non-light emitting laser
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Methylene Blue
2021
Completed Phase 4
~1390
Light emitting laser
2020
Completed Phase 4
~60
Conventional mechanical therapy
2020
Completed Phase 4
~60

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
912 Previous Clinical Trials
323,666 Total Patients Enrolled
2 Trials studying Dental Implants
66 Patients Enrolled for Dental Implants
Academy of Laser Dentistry (ALD)UNKNOWN
Marcos E Garcia, DDSPrincipal InvestigatorThe University of Texas Health Science Center, Houston
~11 spots leftby Jun 2025
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