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

University of Pavia

Status

Completed

Conditions

Diabetes Mellitus With Periodontal Disease

Treatments

Other: Standard toothpaste

Other: Peribioma Toothpaste and Mousse

Study type

Interventional

Funder types

Other

Identifiers

NCT04865809

2021-DIAB1

Details and patient eligibility

About

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).

Full 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).

Enrollment

40 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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