Diabetes, Periodontitis
Conditions
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).
Interventions
DEVICEHyperbaric Oxygen therapy
OTHERConventional Wound Therapies
Sponsors
Loma Linda University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to 80 Years
Healthy volunteers
No
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%
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CWC With HBO Conventional Wound Therapies (CWC) with adjunctive Hyperbaric Oxygen Therapy
Hyperbaric Oxygen therapy
Conventional Wound Therapies | 3 |
| CWC Without HBO Conventional Wound Therapies (CWC) without adjunctive Hyperbaric Oxygen Therapy
Conventional Wound Therapies | 0 |
| Total | 3 |
Baseline characteristics
| Characteristic | CWC With HBO | CWC Without HBO | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 0 Participants | 2 Participants |
| Sex: Female, Male Female | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Male | 2 Participants | 0 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
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.
Time frame: 12 weeks
Population: No analysis conducted due to not enough subjects recruited and study terminated early.