Periodontal Diseases
Conditions
Keywords
plaque, laser therapy
Brief summary
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
Interventions
DEVICEmechanical debridement
subjects will receive traditional non-surgical mechanical debridement of tooth surfaces with scalers and ultrasonics removing supragingival and subgingival plaque
DEVICEadjunctive 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.
DEVICEsham aPDT
subjects will receive saline and non-light emitting laser on the tooth
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Number of Bleeding Sites (Bleeding On Probing) | baseline, at the re-evaluation appointment(4 to 6 weeks after baseline) | Bleeding on probing will be evaluated by gently sweeping the periodontal probe just within the gingival sulcus of the tooth and the presence or absence of bleeding will be recorded .The change is reported as \[(number of bleeding sites (bleeding on probing) at the re-evaluation appointment(4 to 6 weeks after baseline) - (number of bleeding sites (bleeding on probing) at baseline)\] - a negative value indicated less bleeding sites. |
| Change in Probing Depth (Periodontal Pocket Depth ) | baseline, at the re-evaluation appointment (4 to 6 weeks after baseline) | Periodontal pocket depth is measured from the free gingival margin to the base of the pocket, with a UNC periodontal probe with 1mm measurement units. The change is reported as \[Periodontal pocket depth at the re-evaluation appointment(4 to 6 weeks after baseline) - (Periodontal pocket depth at baseline)\] - a negative value indicates a reduction in pocket depth |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Microbiologic Profile of Plaque as Indicated by Percent of Total Abundance of 4 Oral Bacterial Complexes | baseline | Plaque will be sampled, and the subgingival periodontal microbiome will be categorized into different clusters of bacterial species (referred to as Socransky's complexes). We report the percent abundance of 4 different complexes: 1) the Yellow Complex (consisting of S. mutans, S. parasanguinis\_clade\_411, S. sinensis, and S. vestibularis); the Blue Complex (consisting of Actinomyces gerencseriae, Actinomyces HMT\_169, and Actinomyces timonensis); the Orange Complex (consisting of Prevotella fusca, Prevotella histicola, Prevotella jejuni, Prevotella koreensis, Prevotella melaninogenica, Prevotella multiformis, Prevotella nigrescens, Prevotella oris, Prevotella pleuritidis, Prevotella salivae, Prevotella HMT\_292, Prevotella HMT\_314, Prevotella HMT\_443, Prevotella veroralis, Capnocytophaga HMT\_412, S. constellatus, and Campylobacter curvus); and the Red Complex (consisting of Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola, Treponema HMT\_231, and Treponema HMT\_237). |
| Change in Microbiologic Profile of Gingival Crevicular Fluid(GCF) | baseline, at the re-evaluation appointment (4 to 6 weeks after baseline), and 3 months after baseline | GCF will be collected from the sulcus around the target tooth using paper strips (PerioPaper, Oraflow). With proper isolation using cotton rolls in the buccal and lingual aspects of the study site, the area will be dried for 5 seconds with compressed air. The paper strip will be gently introduced into the mucosal crevice around the tooth for 30 seconds per site in four sites.The strips will then be removed from the crevice, and the volume of fluid collected in each strip measured using a micromoisture metering device (Peritron, Oraflow). After confirming the adequateness of the volume, the paper strips from each tooth will be transferred into labeled tubes and stored at -80 C for later use. For analysis, the paper strips will be analyzed using multiplexed fluorescent bead-based immunoassay. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORShreena P Bhakta, DDS
The University of Texas Health Science Center, Houston
Participant flow
Pre-assignment details
20 participants were enrolled. Each participant served as their own control. For each participant 2 teeth were treated - 1 tooth was treated with Adjunctive aPDT and 1 tooth was treated with sham aPDT.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 61.90 years STANDARD_DEVIATION 5.78 |
| Initial Periodontal Diagnosis Generalized Stage III Grade B | 10 participants |
| Initial Periodontal Diagnosis Localized Stage II Grade B | 5 participants |
| Initial Periodontal Diagnosis Localized Stage III Grade B | 5 participants |
| Number of Bleeding Sites (Bleeding On Probing) | 3.60 bleeding sites STANDARD_DEVIATION 1.27 |
| Number of Participants with Diabetes | 1 participants |
| Number of Participants with Hypertension | 8 participants |
| Number of Participants with Osteoporosis | 1 participants |
| Probing Depth (Periodontal Pocket Depth ) | 3.35 millimeters STANDARD_DEVIATION 0.43 |
| Race/Ethnicity, Customized African American | 4 participants |
| Race/Ethnicity, Customized Caucasian | 4 participants |
| Race/Ethnicity, Customized Hispanic | 11 participants |
| Race/Ethnicity, Customized Middle Eastern | 1 participants |
| Region of Enrollment United States | 20 participants |
| Sex/Gender, Customized Female | 16 participants |
| Sex/Gender, Customized Male | 4 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
None listed