Hyperbaric Oxygen Therapy as Adjunctive Therapy to Scaling and Root-planing in the Management of Periodontitis in Patients With Type 2 Diabetes
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02671136|
Recruitment Status : Terminated (Lack of subjects)
First Posted : February 2, 2016
Results First Posted : March 13, 2019
Last Update Posted : March 13, 2019
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).
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Periodontitis||Device: Hyperbaric Oxygen therapy Other: Conventional Wound Therapies||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Hyperbaric Oxygen Therapy as Adjunctive Therapy to Scaling and Root-planing in the Management of Periodontitis in Patients With Type 2 Diabetes|
|Actual Study Start Date :||August 18, 2016|
|Actual Primary Completion Date :||March 31, 2017|
|Actual Study Completion Date :||March 31, 2017|
CWC with HBO
Conventional Wound Therapies (CWC) with adjunctive Hyperbaric Oxygen Therapy
Device: Hyperbaric Oxygen therapy
Other: Conventional Wound Therapies
CWC without HBO
Conventional Wound Therapies (CWC) without adjunctive Hyperbaric Oxygen Therapy
Other: Conventional Wound Therapies
- Counts of Each Subgingival Bacterial Species [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02671136
|United States, California|
|Loma Linda University|
|Loma Linda, California, United States, 92346|
|Principal Investigator:||Ahmed Khocht, DDS||Faculty|