| Trial ID: | L5048 |
| Source ID: | NCT00801164
|
| Associated Drug: |
Frio Mouth Rinse Placebo
|
| Title: |
Exploratory Study of Iocide Oral Rinse in a Diabetic Population
|
| Acronym: |
Diabetes
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Type 2|Periodontitis
|
| Interventions: |
DRUG: Frio Mouth Rinse Placebo|DRUG: Frio Mouth Rinse
|
| Outcome Measures: |
Primary: The primary study endpoints are periodontal evaluation including clinical attachment level, pocket depth, plaque index, suppuration and gingival index score., 6 Months | Secondary: Secondary endpoints include glycated hemoglobin A1c (HbA1c) and systemic biomarkers (LPS, TNF-a, CRP, IL-6, serum insulin and glucose). Tertiary outcome measures include staining, calculus, opportunistic Candida infection, and patient satisfaction., 6 Months
|
| Sponsor/Collaborators: |
Sponsor: Biomedical Development Corporation | Collaborators: Methodist Healthcare Ministries of South Texas|Foundation Of Collaborative Unique Science (FOCUS)
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
30
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
|
| Start Date: |
2008-12
|
| Completion Date: |
2010-06
|
| Results First Posted: |
|
| Last Update Posted: |
2012-02-02
|
| Locations: |
The University of Texas Health Science Center at San Antonio, Dental School, San Antonio, Texas, 78229, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00801164
|
