Hyperbaric Oxygen Therapy as Adjunctive Therapy to Scaling and Root-planing in the Management of Periodontitis in Patients With Type 2 Diabetes

Study Overview
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Brief Summary
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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).

Official Title
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Hyperbaric Oxygen Therapy as Adjunctive Therapy to Scaling and Root-planing in the Management of Periodontitis in Patients With Type 2 Diabetes

Conditions
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Diabetes, Periodontitis

Intervention / Treatment
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* Device: Hyperbaric Oxygen therapy
* Other: Conventional Wound Therapies


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diabetes type 2 (HbA1c =>7%) Generalized moderate to severe chronic periodontitis. Minimum of 10 permanent teeth Registered LLU patients Exclusion Criteria: Well controlled Diabetes type 2 Other systematic conditions with known associations to periodontitis Intra-oral conditions which may interfere with the accuracy of periodontal probing BMI greater than 45%

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: CWC with HBO<br>Conventional Wound Therapies (CWC) with adjunctive Hyperbaric Oxygen Therapy | Device: Hyperbaric Oxygen therapy<br> <br> Other: Conventional Wound Therapies<br> <br> |
| Other: CWC without HBO<br>Conventional Wound Therapies (CWC) without adjunctive Hyperbaric Oxygen Therapy | Other: Conventional Wound Therapies<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Counts of Each Subgingival Bacterial Species | Subgingival microbial samples will be obtained at baseline and end of the study. Subgingival microbial samples will be collected from three randomly selected sites with probing depth =>5mm. Collected microbial samples will be processed for HOMINGS analysis (The Human Oral Microbe Identification Microarray). Counts and proportions of each bacterial species will be determined for each subject and then averaged across subjects in the two groups. Differences in bacterial profiles will be analyzed using the repeated measures ANCOVA (Analysis of Covariance) procedure for paired observations. | 12 weeks |