The goals of this exploratory study are to 1)examine an investigational oral rinse as an adjunctive agent to scaling and root planing in treating chronic periodontitis in a periodontitis-susceptible diabetes population, and 2) evaluate its effect on glycemic control and biomarkers of systemic inflammation.
This double-blind prospective pilot study will evaluate the effects of an investigational oral rinse as an adjunctive agent to non-surgical periodontal intervention for patients with type 2 diabetes mellitus. Approximately thirty (30) adult (35 years or older) patients with type 2 diabetes mellitus with untreated chronic periodontitis of moderate or worse severity will be enrolled in the 6-month study to provide 24 evaluable subjects (12 per group). All subjects enrolled in the trial will receive standard periodontal therapy including scaling and root planing (SRP). Half will be randomized to receive the investigational oral rinse adjunctively twice daily; the other half will receive placebo rinse twice daily. Study participants will be treated with either Iocide or placebo rinse for the first 90 days of the study only. Follow up examinations will be performed at six months. Evaluation of biological markers associated with systemic inflammation and diabetes will be performed at baseline, three months, and six months. The primary study outcome is clinical measurement of chronic periodontitis (gingival index, bleeding on probing, probing depth, clinical attachment level). Secondary outcomes are change in HbA1c and markers of systemic inflammation measured by serum C-reactive protein, plasma TNF-a, and IL-6.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
30
Prescription Mouth Rinse. Rinse with 15ml twice daily then expectorate.
Prescription Mouth Rinse. Rinse with 15ml twice daily then expectorate.
The University of Texas Health Science Center at San Antonio, Dental School
San Antonio, Texas, United States
The primary study endpoints are periodontal evaluation including clinical attachment level, pocket depth, plaque index, suppuration and gingival index score.
Time frame: 6 Months
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.
Time frame: 6 Months
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