Use of Ozonized Water With Toothpaste and Mousse in Non Surgical Periodontal Therapy for Patients With Diabetes Mellitus Type 1: a Randomized Clinical Trial.

Study Overview
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Brief Summary
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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: 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
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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 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).

Official Title
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Professional and Home Oral Care With Non Surgical Periodontal Therapy for the Evaluation of Glycosylated Hemoglobin (HbA1c) in Patients Suffering From Diabetes Mellitus Type 1: a Randomized Clinical Trial.

Conditions
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Diabetes Mellitus With Periodontal Disease

Intervention / Treatment
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* Other: Peribioma Toothpaste and Mousse
* Other: Standard toothpaste


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trial Group<br>Patients from this group will use Peribioma Toothpaste and Mousse for home oral care. | Other: Peribioma Toothpaste and Mousse<br>* Use of Peribioma Toothpaste and Mousse for home oral care.<br>|
| Active Comparator: Control Group<br>Patients from this group will use Biorepair Plus Parodontgel for home oral care. | Other: Standard toothpaste<br>* Use of Biorepair Plus Parodontgel for home oral care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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; = thin plaque layer at the gingival margin, only detectable by scraping with a probe; = moderate layer of plaque along the gingival margin; interdental spaces free, but plaque is visible to the naked eye; = abundant plaque along the gingival margin; interdental spaces filled with 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ozonized water, glycosylated hemoglobin