Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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: 1. Red, swollen gingival tissues surrounding the implant 2. Presence of bleeding and/or suppuration on gentle probing around the implant 3. Increased probing depth compared to probing depth after restoration of the implant (greater than 2mm increase in probing depth) 4. 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

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Conventional mechanical therapy with aPDT adjunct
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.
  • Procedure: Conventional mechanical therapy
    Both experimental and sham arms will receive the Conventional mechanical therapy
  • Drug: Methylene Blue
    Experimental arm will receive methylene blue
  • Device: Light emitting laser
    Experimental arm will receive Light emitting laser
Sham Comparator
Conventional mechanical therapy with sham aPDT treatment
Control group will have conventional mechanical instrumentation of implant site with "Sham" aPDT treatment with saline and non-light emitting laser
  • 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
  • Device: Non-light emitting laser
    Sham group will receive Non-light emitting laser

Recruiting Locations

University of Texas Health Science Center at Houston School of Dentistry
Houston, Texas 77030
Contact:
Jiayin Tan, DDS
713-486-4048
Jiayin.Tan@uth.tmc.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

Jiayin Tan, DDS
713-486-4048
Jiayin.Tan@uth.tmc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.