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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: Clinical Trial NA study, sponsored by Loma Linda University.
NCT02671136 is a NA study that was terminated before completion, run by Loma Linda University. The registered enrollment target is 3 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
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 u
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 |
Why NCT02671136 stopped before completion
NCT02671136 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 2 interventions - of which Hyperbaric Oxygen therapy is the first listed.
NCT02671136 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02671136's enrollment target sits among peer trials
3 1996th of 2000 higher than 4 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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