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

NCT04865809 | Completed

• 1 other identifier: 2021-DIAB1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Diabetes Mellitus With Periodontal Disease

Keywords

ozonized water; glycosylated hemoglobin

Outcome Measures

Primary Outcomes (5)

• 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; 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.

  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.

Study Arms (2)

Trial Group

EXPERIMENTAL

Patients from this group will use Peribioma Toothpaste and Mousse for home oral care.

Other: Peribioma Toothpaste and Mousse

Control Group

ACTIVE COMPARATOR

Patients from this group will use Biorepair Plus Parodontgel for home oral care.

Other: Standard toothpaste

Interventions

Peribioma Toothpaste and Mousse OTHER

Use of Peribioma Toothpaste and Mousse for home oral care.

Trial Group

Standard toothpaste OTHER

Use of Biorepair Plus Parodontgel for home oral care

Control Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients suffering from Diabetes Mellitus Type 1
• adult patients
• patients who agreed to participate to the study and that signed the informed consent.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pavia: lead

Study Sites (1)

Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia

Pavia, Lombardy, 27100, Italy

Location

Study Officials

• Andrea Scribante, DDS, PhD.

  University of Pavia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Resident, Principal Investigator

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: April 29, 2021
• Study Start: May 12, 2021
• Primary Completion: January 13, 2022
• Study Completion: January 16, 2022
• Last Updated: March 29, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)