NCT02671136

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable diabetes

Timeline
Completed

Started Aug 2016

Shorter than P25 for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 6, 2015

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 2, 2016

Completed
7 months until next milestone

Study Start

First participant enrolled

August 18, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2017

Completed
2 years until next milestone

Results Posted

Study results publicly available

March 13, 2019

Completed
Last Updated

March 13, 2019

Status Verified

February 1, 2019

Enrollment Period

8 months

First QC Date

October 6, 2015

Results QC Date

August 22, 2018

Last Update Submit

February 15, 2019

Conditions

DiabetesPeriodontitis

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 weeks

Study Arms (2)

CWC with HBO

OTHER

Conventional Wound Therapies (CWC) with adjunctive Hyperbaric Oxygen Therapy

Device: Hyperbaric Oxygen therapyOther: Conventional Wound Therapies

CWC without HBO

OTHER

Conventional Wound Therapies (CWC) without adjunctive Hyperbaric Oxygen Therapy

Other: Conventional Wound Therapies

Interventions

Hyperbaric Oxygen therapyDEVICE
CWC with HBO
Conventional Wound TherapiesOTHER
CWC with HBOCWC without HBO

Eligibility Criteria

Age35 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diabetes type 2 (HbA1c =\>7%)
  • Generalized moderate to severe chronic periodontitis.
  • Minimum of 10 permanent teeth
  • Registered LLU patients

You may not qualify if:

  • 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%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loma Linda University

Loma Linda, California, 92346, United States

Location

MeSH Terms

Conditions

Diabetes MellitusPeriodontitis

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Oxygen Inhalation TherapyRespiratory TherapyTherapeutics

Results Point of Contact

Title
Ahmed Khocht
Organization
Loma Linda University Health
akhocht@llu.edu
909 558 4000

Study Officials

  • Ahmed Khocht, DDS

    Faculty

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2015

First Posted

February 2, 2016

Study Start

August 18, 2016

Primary Completion

March 31, 2017

Study Completion

March 31, 2017

Last Updated

March 13, 2019

Results First Posted

March 13, 2019

Record last verified: 2019-02

Locations

US(1)