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Purpose

The purpose of this study is to compare clinical outcomes after mechanical debridement of at sites exhibiting plaque induced inflammation with or without adjunctive Antimicrobial photodynamic therapy (aPDT) and to assess the the microbiologic profile before and after treatment with or without aPDT

Condition

Eligibility

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

Inclusion Criteria

  • One pocket on each side of the mouth (split design) - Single rooted tooth - Pocket depths measured greater than 4mm with bleeding on probing - Horizontal bone loss - No furcation involvement

Exclusion Criteria

  • current heavy smokers (>10 cigarettes/day) - have uncontrolled diabetes (HbA1c ≥ 6.5%) - other uncontrolled systemic diseases that may comprise healing, such as Vitamin C deficiency, any neutrophil deficiencies, immunodeficiency syndromes, or leukemia - taking antibiotics within 3 months before the procedure - vertical bone defects that requires surgical regenerative treatment. - Pregnancy

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
mechanical debridement and adjunctive aPDT
  • Device: mechanical debridement
    subjects will receive traditional non-surgical mechanical debridement of tooth surfaces with scalers and ultrasonics removing supragingival and subgingival plaque
  • Device: adjunctive aPDT
    Antimicrobial photodynamic therapy will be done at tooth sites by applying a photosensitizing dye methylene blue (0.1mg/ml) with a disposable syringe from the bottom of pocket in a coronal direction. After 3 minutes in situ, the surrounding gingival tissues will be irradiated at six sites around the tooth 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.
Active Comparator
mechanical debridement and sham aPDT
  • Device: mechanical debridement
    subjects will receive traditional non-surgical mechanical debridement of tooth surfaces with scalers and ultrasonics removing supragingival and subgingival plaque
  • Device: sham aPDT
    subjects will receive saline and non-light emitting laser on the tooth

Recruiting Locations

The University of Texas Health Science Center at Houston
Houston, Texas 77030
Contact:
Shreena P Bhakta, DDS
713-499-9072
Shreena.P.Bhakta@uth.tmc.edu

More Details

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

Study Contact

Shreena P Bhakta, DDS
713-499-9072
Shreena.P.Bhakta@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.