Diabetes Clinical Trial
Official title:
Hyperbaric Oxygen Therapy as Adjunctive Therapy to Scaling and Root-planing in the Management of Periodontitis in Patients With Type 2 Diabetes
Diabetes and Periodontitis are both prevalent diseases affecting millions of Americans.
Periodontitis is prevalent among Diabetics. Furthermore, Periodontitis and associated
inflammation can increase insulin resistance in Diabetics and worsens the condition.
Hyperbaric Oxygen Therapy (HBOT) has the potential to improve periodontal treatment outcome
in poorly controlled diabetics. The study will compare periodontal treatment (SRP) outcome
between 2 main diabetic type 2 patient groups receiving medical care treatment: either
Conventional Wound Therapies (CWC) with or without adjunctive Hyperbaric Oxygen Therapy at
LLU Health.
24 poorly controlled diabetic mellitus (DM) type 2 subjects (HbA1c =>7%) with Periodontitis
will be assigned into the study arms HBO therapy and Non HBO therapy, based on their medical
needs.
For all subjects demographic data (age, gender, ethnicity, smoking history, alcohol use
history, BMI, current medication list) and oral health habits will be obtained. Blood samples
for HbA1c determinations, clinical periodontal measurements (plaque index, probing
measurements including pocket depth, attachment levels, gingival index and
bleeding-on-probing) and subgingival microbial samples will be obtained at baseline and end
of the study. Subgingival microbial samples will be collected from three randomly selected
sites and analyzed for detection of about 300 of the most prevalent oral bacterial species.
Differences in periodontal clinical outcomes and bacterial profiles will be identified
utilizing ANCOVA (Analysis of Covariance).
n/a
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