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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CWC with HBO | Other | Conventional Wound Therapies (CWC) with adjunctive Hyperbaric Oxygen Therapy |
|
| CWC without HBO | Other | Conventional Wound Therapies (CWC) without adjunctive Hyperbaric Oxygen Therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyperbaric Oxygen therapy | Device |
| ||
| Conventional Wound Therapies |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ahmed Khocht, DDS | Faculty | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University | Loma Linda | California | 92346 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | CWC With HBO | Conventional Wound Therapies (CWC) with adjunctive Hyperbaric Oxygen Therapy Hyperbaric Oxygen therapy Conventional Wound Therapies |
| FG001 | CWC Without HBO | Conventional Wound Therapies (CWC) without adjunctive Hyperbaric Oxygen Therapy Conventional Wound Therapies |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 30, 2015 |
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| Other |
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| COMPLETED |
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| NOT COMPLETED |
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This project was terminated early due to not enough subjects recruited.
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| ID | Title | Description |
|---|---|---|
| BG000 | CWC With HBO | Conventional Wound Therapies (CWC) with adjunctive Hyperbaric Oxygen Therapy Hyperbaric Oxygen therapy Conventional Wound Therapies |
| BG001 | CWC Without HBO | Conventional Wound Therapies (CWC) without adjunctive Hyperbaric Oxygen Therapy Conventional Wound Therapies |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | No analysis conducted due to not enough subjects recruited and study terminated early. | Posted | 12 weeks |
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No adverse event data collected. Study terminated early due to not enough subjects enrolled.
No adverse event data collected. Study terminated early due to not enough subjects enrolled.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CWC With HBO | Conventional Wound Therapies (CWC) with adjunctive Hyperbaric Oxygen Therapy Hyperbaric Oxygen therapy Conventional Wound Therapies | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | CWC Without HBO | Conventional Wound Therapies (CWC) without adjunctive Hyperbaric Oxygen Therapy Conventional Wound Therapies | 0 | 0 | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ahmed Khocht | Loma Linda University Health | 909 558 4000 | akhocht@llu.edu |
| Feb 15, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D006931 | Hyperbaric Oxygenation |
| ID | Term |
|---|---|
| D010102 | Oxygen Inhalation Therapy |
| D012138 | Respiratory Therapy |
| D013812 | Therapeutics |
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| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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