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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
at least one implant with peri-implant inflammation that requires non-surgical treatment.
Peri-implant diseases included are peri-implant mucositis and peri-implantitis
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

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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
902 Previous Clinical Trials
321,115 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still openings for individuals to participate in this research?

"Affirmative. Clinicaltrials.gov indicates that the trial, initially posted on February 14th 2020, is actively seeking patients to fill 64 available spots at 1 location."

Answered by AI

What potential hazards are associated with Methylene Blue consumption?

"Due to its Phase 4 designation, which means FDA approval, Methylene Blue was rated a 3 for safety on our scale at Power."

Answered by AI

What is the total size of the cohort involved in this research trial?

"Affirmative, per the information provided by clinicaltrials.gov this research is actively recruiting participants. This study was initially posted on February 14th 2020 and its latest update has been recorded on October 31st 2022. Sixty-four individuals can be enrolled at a single trial location."

Answered by AI

What conditions typically warrant Methylene Blue as a course of treatment?

"Methylene Blue is known as an effective remedy for urethritis, nephritis, and inflammation."

Answered by AI

Who else is applying?

What state do they live in?
Texas
Tennessee
What site did they apply to?
University of Texas Health Science Center at Houston School of Dentistry
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. University of Texas Health Science Center at Houston School of Dentistry: < 24 hours
Average response time
  • < 1 Day
~11 spots leftby Mar 2025