Clinical trial 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.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus With Periodontal Disease
Keywords: ozonized water
glycosylated hemoglobin
Lead sponsor: University of Pavia
Sponsor class: OTHER
First posted: 2021-04-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in Glycosylated Hemoglobin (HbA1c)
timeFrame: Baseline, 3 and 6 months.
measure: Change in CAL - Clinical Attachment Loss
timeFrame: Baseline, 3 and 6 months.
measure: Change in PI - Plaque Index (Silness and Löe, 1964)
timeFrame: Baseline, 3 and 6 months.
measure: Change in PPD - Probing Pocket Depth
timeFrame: Baseline, 3 and 6 months.
measure: Change in BOP - Bleeding on Probing (percentage)
timeFrame: Baseline, 3 and 6 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
state: Lombardy
Study officials:
affiliation: University of Pavia
name: Andrea Scribante, DDS, PhD.
role: PRINCIPAL_INVESTIGATOR
References: