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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

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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
Sponsor:
Information provided by (Responsible Party):
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).


Condition or disease Intervention/treatment Phase
Diabetes Periodontitis Device: Hyperbaric Oxygen therapy Other: Conventional Wound Therapies Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   35 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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%

Information from the National Library of Medicine

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


Locations
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United States, California
Loma Linda University
Loma Linda, California, United States, 92346
Sponsors and Collaborators
Loma Linda University
Investigators
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Principal Investigator: Ahmed Khocht, DDS Faculty
  Study Documents (Full-Text)

Documents provided by Loma Linda University:
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Responsible Party: Loma Linda University
ClinicalTrials.gov Identifier: NCT02671136    
Other Study ID Numbers: 5150307
First Posted: February 2, 2016    Key Record Dates
Results First Posted: March 13, 2019
Last Update Posted: March 13, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Periodontitis
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases