Diabetes Mellitus With Periodontal Disease
Conditions
Keywords
ozonized water, glycosylated hemoglobin
Brief summary
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: * Trial Group: patients will use Biorepair Peribioma Toothpaste and Mousse for home oral care * Control Group: patients will use Biorepair Plus Parodontgel toothpaste for home oral care. 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).
Detailed description
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: * Trial Group: patients will use Biorepair Peribioma Toothpaste and Mousse for home oral care until the end of the study; * Control Group: patients will use Biorepair Plus Parodontgel toothpaste for home oral care until the end of the study. 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).
Interventions
OTHERPeribioma Toothpaste and Mousse
Use of Peribioma Toothpaste and Mousse for home oral care.
OTHERStandard toothpaste
Use of Biorepair Plus Parodontgel for home oral care
Sponsors
University of Pavia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* patients suffering from Diabetes Mellitus Type 1 * adult patients * patients who agreed to participate to the study and that signed the informed consent.
Exclusion criteria
* patients taking intravenous or oral Bisphosphonates at the study begin or in the previous 12 months * patients with low compliance and motivation to participate * pazienti irradiati alla testa o collo negli ultimi 12 mesi * pregnant or breastfeeding women * alcohol and drug abuse * patients with psychiatric diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Glycosylated Hemoglobin (HbA1c) | Baseline, 3 and 6 months. | Serum levels of glycosylated hemoglobin |
| Change in CAL - Clinical Attachment Loss | Baseline, 3 and 6 months. | Measurement (in mm) of the position of the gingival margin in relation to the cemento-enamel junction (CEJ). |
| Change in PI - Plaque Index (Silness and Löe, 1964) | Baseline, 3 and 6 months. | Scoring criteria: 0 = no plaque; 1. = thin plaque layer at the gingival margin, only detectable by scraping with a probe; 2. = moderate layer of plaque along the gingival margin; interdental spaces free, but plaque is visible to the naked eye; 3. = abundant plaque along the gingival margin; interdental spaces filled with plaque. |
| Change in PPD - Probing Pocket Depth | Baseline, 3 and 6 months. | 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. |
| Change in BOP - Bleeding on Probing (percentage) | Baseline, 3 and 6 months. | 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%. |
Countries
Italy
Outcome results
None listed