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NCT02671136 · ClinicalTrials.gov registry record · NA
Hyperbaric Oxygen Therapy as Adjunctive Therapy to Scaling and Root-planing in the Management of Periodontitis in Patients With Type 2 Diabetes
A NA study, sponsored by Loma Linda University.
- Terminated
- Registry status
- NA
- Development phase
- 3
- Enrollment target
NCT02671136 is a NA study that was terminated before completion, run by Loma Linda University. The registered enrollment target is 3 participants.
The verdict
NCT02671136, a NA study, was terminated before completion, sponsored by Loma Linda University.
- TERMINATED
- Registry status
- NA
- Development phase
- 3 participants
- Enrollment target
Study 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).
Interventions
- DEVICE Hyperbaric Oxygen therapy
- OTHER Conventional Wound Therapies
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2016-08-18 |
| Est. Completion | 2017-03-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02671136
The ClinicalTrials.gov registry entry for NCT02671136 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Loma Linda University, which has 237 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Hyperbaric Oxygen therapy is the first listed.
NCT02671136 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02671136 about?
NCT02671136 is a clinical study titled "Hyperbaric Oxygen Therapy as Adjunctive Therapy to Scaling and Root-planing in the Management of Periodontitis in Patients With Type 2 Diabetes". 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 ...
What is the current status of trial NCT02671136?
This trial is currently terminated. It is a NA study. The enrollment target is 3 participants. The study started on 2016-08-18. Estimated completion is 2017-03-31.
What interventions are being tested in trial NCT02671136?
The interventions under investigation include: Hyperbaric Oxygen therapy (DEVICE), Conventional Wound Therapies (OTHER).
Who is sponsoring clinical trial NCT02671136?
This trial is sponsored by Loma Linda University, which has 237 total clinical trials registered on ClinicalTrials.gov.
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