Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Methodist Healthcare Ministries of South Texas | UNKNOWN |
| Foundation Of Collaborative Unique Science (FOCUS) | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Frio Oral Rinse | Experimental | Prescription Mouth Rinse. Rinse with 15ml twice daily then expectorate. |
|
| Placebo | Experimental | Prescription Mouth Rinse. Rinse with 15ml twice daily then expectorate. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Frio Mouth Rinse Placebo | Drug | Prescription Mouth Rinse. Rinse with 15ml twice daily then expectorate. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary study endpoints are periodontal evaluation including clinical attachment level, pocket depth, plaque index, suppuration and gingival index score. | 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Thomas W. Oates, DMD, Ph.D. | University of Texas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at San Antonio, Dental School | San Antonio | Texas | 78229 | United States |
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Frio Mouth Rinse | Drug | Prescription Mouth Rinse. Rinse with 15ml twice daily then expectorate. |
|
| D004700 | Endocrine System Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |