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

Not Applicable

Completed

• Conditions: Diabetes Mellitus With Periodontal Disease
• Interventions: Other: Peribioma Toothpaste and Mousse; Other: Standard toothpaste

• Registration Number: NCT04865809
• Lead Sponsor: University of Pavia

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).

Study Timeline

• Study First Submitted: 2021-04-26
• Study First Submitted QC: 2021-04-26
• Study First Posted: 2021-04-29
• Study Start: 2021-05-12
• Primary Completion: 2022-01-13
• Study Completion: 2022-01-16
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-13
• Last Update Posted: 2022-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Trial Group	Peribioma Toothpaste and Mousse	Patients from this group will use Peribioma Toothpaste and Mousse for home oral care.
Control Group	Standard toothpaste	Patients from this group will use Biorepair Plus Parodontgel for home oral care.

Primary Outcome Measures

Name	Time	Method
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 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%.
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.

Trial Locations

Locations (1)

Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia; 🇮🇹 Pavia, Lombardy, Italy