Hyperbaric Oxygen Therapy as Adjunctive Therapy to Scaling and Root-planing in the Management of Periodontitis in Patients With Type 2 Diabetes

NCT ID: NCT02671136

Last Updated: 2019-03-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-18
• Study Completion Date: 2017-03-31

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).

Conditions

Diabetes; Periodontitis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CWC with HBO

Conventional Wound Therapies (CWC) with adjunctive Hyperbaric Oxygen Therapy

Group Type: OTHER

Hyperbaric Oxygen therapy

Intervention Type: DEVICE

Conventional Wound Therapies

Intervention Type: OTHER

CWC without HBO

Conventional Wound Therapies (CWC) without adjunctive Hyperbaric Oxygen Therapy

Group Type: OTHER

Conventional Wound Therapies

Intervention Type: OTHER

Interventions

Hyperbaric Oxygen therapy

Intervention Type: DEVICE

Conventional Wound Therapies

Intervention Type: OTHER

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%

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Loma Linda University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ahmed Khocht, DDS

Role: PRINCIPAL_INVESTIGATOR

Faculty

Locations

Loma Linda University

Loma Linda, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

5150307

Identifier Type: -

Identifier Source: org_study_id