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

NCT04187053 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2024-02-21

Study results available
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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.

Conditions

  • DENT IMPLANTS
  • LASER

Interventions

PROCEDURE

Conventional mechanical therapy

Both experimental and sham arms will receive the Conventional mechanical therapy

DRUG

Saline

Sham group will receive saline as a sham for methylene blue

DRUG

Methylene Blue

Experimental arm will receive methylene blue

DEVICE

Light emitting laser

Experimental arm will receive Light emitting laser

DEVICE

Non-light emitting laser

Sham group will receive Non-light emitting laser

Sponsors & Collaborators

  • Academy of Laser Dentistry

    collaborator OTHER

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Jiayin Tan, DDS · The University of Texas Health Science Center, Houston

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-14
Primary Completion
2022-12-06
Completion
2022-12-06
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04187053 on ClinicalTrials.gov