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

Not Applicable

Terminated

Conditions: Diabetes
Periodontitis

Interventions: Device: Hyperbaric Oxygen therapy
Other: Conventional Wound Therapies

Registration Number: NCT02671136

Lead Sponsor: Loma Linda University

Brief Summary: 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).

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 3

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%

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CWC with HBO	Hyperbaric Oxygen therapy	Conventional Wound Therapies (CWC) with adjunctive Hyperbaric Oxygen Therapy
CWC with HBO	Conventional Wound Therapies	Conventional Wound Therapies (CWC) with adjunctive Hyperbaric Oxygen Therapy
CWC without HBO	Conventional Wound Therapies	Conventional Wound Therapies (CWC) without adjunctive Hyperbaric Oxygen Therapy

Primary Outcome Measures

Name	Time	Method
Counts of Each Subgingival Bacterial Species	12 weeks	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.

Secondary Outcome Measures