CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 56 enrolled
Drug / intervention
Saline +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04187053
NCT04187053Phase 4Completed

Clinical and Microbiologic Outcomes of Adjunctive Antimicrobial Photodynamic Therapy in the Non-surgical Treatment of Peri-implant Disease

The University of Texas Health Science Center, Houston·interventional·Posted Dec 5, 2019·Updated Feb 21, 2024

In Brief

A Phase 4 clinical trial evaluating Conventional mechanical therapy, Saline, and 3 other interventions for DENT IMPLANTS and LASER. Completed, enrolled 56 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDENT IMPLANTS, LASER
CountriesUnited States

Timeline

Phase 4CompletedFinished
2020202120222023202420252026
First PostedDec 5, 2019
Enrollment StartFeb 14, 2020
Primary CompletionDec 6, 2022
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 6.6 years ago

Interventions

Conventional mechanical therapyprocedure

Both experimental and sham arms will receive the Conventional mechanical therapy

Salinedrug

Sham group will receive saline as a sham for methylene blue

Methylene Bluedrug

Experimental arm will receive methylene blue

Light emitting laserdevice

Experimental arm will receive Light emitting laser

Non-light emitting laserdevice

Sham group will receive Non-light emitting laser