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The aim of this study is to evaluate the efficacy of Peribioma Toothpaste and Mousse for home oral care in patients with Diabetes Mellitus Type 1.
Patients will undergo a professional oral hygiene procedure, followed by irrigation with ozonized water.
Patients will be randomly divided into two groups:
The variations of the following indices will be evaluated at the baseline, after 3 and 6 months: glycosylated hemoglobin (HbA1c) , Clinical Attachment Level (CAL), Plaque Index (PI), Probing Pocket Depth (PPD) and Bleeding on Probing (BoP).
The aim of this study is to evaluate the efficacy of Peribioma Toothpaste and Mousse for home oral care in patients with Diabetes Mellitus Type 1.
Patients who respond to eligibility criteria and that will sign the informed consent will undergo a professional oral hygiene procedure; then, ozonized water (aquolab) will be used to irrigate periodontal pockets for 1 minute.
Then, patients will be randomly divided into two groups:
Changes in the following indices will be evaluated at the baseline, after 3 and 6 months: glycosylated hemoglobin (HbA1c) , Clinical Attachment Level (CAL), Plaque Index (PI), Probing Pocket Depth (PPD) and Bleeding on Probing (BoP).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trial Group | Experimental | Patients from this group will use Peribioma Toothpaste and Mousse for home oral care. |
|
| Control Group | Active Comparator | Patients from this group will use Biorepair Plus Parodontgel for home oral care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peribioma Toothpaste and Mousse | Other | Use of Peribioma Toothpaste and Mousse for home oral care. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Glycosylated Hemoglobin (HbA1c) | Serum levels of glycosylated hemoglobin | Baseline, 3 and 6 months. |
| Change in CAL - Clinical Attachment Loss | Measurement (in mm) of the position of the gingival margin in relation to the cemento-enamel junction (CEJ). | Baseline, 3 and 6 months. |
| Change in PI - Plaque Index (Silness and Löe, 1964) | Scoring criteria: 0 = no plaque;
| Baseline, 3 and 6 months. |
| Change in PPD - Probing Pocket Depth | Evaluation (in mm) of the depth of the gingival sulcus, through a millimeter periodontal probe; it is detected from the gingival margin to the bottom of the gingival sulcus or periodontal pocket, evaluated at 6 sites. | Baseline, 3 and 6 months. |
| Change in BOP - Bleeding on Probing (percentage) | Site-specific assessment of the presence or absence of gum bleeding after the insertion of the periodontal probe for the detection of PPD, detected on 6 sites. Percentage of sites with bleeding on probing determines the BOP%. | Baseline, 3 and 6 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrea Scribante, DDS, PhD. | University of Pavia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia | Pavia | Lombardy | 27100 | Italy |
Data will be available upon motivated request to Principal Investigator
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| Standard toothpaste | Other | Use of Biorepair Plus Parodontgel for home oral care |
|