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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

Primary Purpose

Diabetes, Periodontitis

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hyperbaric Oxygen therapy
Conventional Wound Therapies
Sponsored by
Loma Linda University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

35 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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%

Sites / Locations

  • Loma Linda University

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

CWC with HBO

CWC without HBO

Arm Description

Conventional Wound Therapies (CWC) with adjunctive Hyperbaric Oxygen Therapy

Conventional Wound Therapies (CWC) without adjunctive Hyperbaric Oxygen Therapy

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
October 6, 2015
Last Updated
February 15, 2019
Sponsor
Loma Linda University
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1. Study Identification

Unique Protocol Identification Number
NCT02671136
Brief Title
Hyperbaric Oxygen Therapy as Adjunctive Therapy to Scaling and Root-planing in the Management of Periodontitis in Patients With Type 2 Diabetes
Official Title
Hyperbaric Oxygen Therapy as Adjunctive Therapy to Scaling and Root-planing in the Management of Periodontitis in Patients With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Terminated
Why Stopped
Lack of subjects
Study Start Date
August 18, 2016 (Actual)
Primary Completion Date
March 31, 2017 (Actual)
Study Completion Date
March 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Loma Linda University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Periodontitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CWC with HBO
Arm Type
Other
Arm Description
Conventional Wound Therapies (CWC) with adjunctive Hyperbaric Oxygen Therapy
Arm Title
CWC without HBO
Arm Type
Other
Arm Description
Conventional Wound Therapies (CWC) without adjunctive Hyperbaric Oxygen Therapy
Intervention Type
Device
Intervention Name(s)
Hyperbaric Oxygen therapy
Intervention Type
Other
Intervention Name(s)
Conventional Wound Therapies
Primary Outcome Measure Information:
Title
Counts of Each Subgingival Bacterial Species
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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%
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Khocht, DDS
Organizational Affiliation
Faculty
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loma Linda University
City
Loma Linda
State/Province
California
ZIP/Postal Code
92346
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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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