NCT04865809

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

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University of Pavia · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Diabetes Mellitus With Periodontal Disease

Interventions

Type	Name	Description
OTHER	Peribioma Toothpaste and Mousse	Use of Peribioma Toothpaste and Mousse for home oral care.
OTHER	Standard toothpaste	Use of Biorepair Plus Parodontgel for home oral care

Timeline

• Start date: 2021-05-12
• Primary completion: 2022-01-13
• Completion: 2022-01-16
• First posted: 2021-04-29
• Last updated: 2022-03-29

Locations

1 site across 1 country: Italy