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

March 13, 2022 updated by: Andrea Scribante, University of Pavia

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.

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Lombardy
      • Pavia, Lombardy, Italy, 27100
        • Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Trial Group
Patients from this group will use Peribioma Toothpaste and Mousse for home oral care.
Other: Peribioma Toothpaste and Mousse
Use of Peribioma Toothpaste and Mousse for home oral care.
Active Comparator: Control Group
Patients from this group will use Biorepair Plus Parodontgel for home oral care.
Other: Standard toothpaste
Use of Biorepair Plus Parodontgel for home oral care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Glycosylated Hemoglobin (HbA1c)
Time Frame: Baseline, 3 and 6 months.
Serum levels of glycosylated hemoglobin
Baseline, 3 and 6 months.
Change in CAL - Clinical Attachment Loss
Time Frame: Baseline, 3 and 6 months.
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)
Time Frame: 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.
Baseline, 3 and 6 months.
Change in PPD - Probing Pocket Depth
Time Frame: 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.
Baseline, 3 and 6 months.
Change in BOP - Bleeding on Probing (percentage)
Time Frame: 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%.
Baseline, 3 and 6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pavia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 12, 2021

Primary Completion (Actual)

January 13, 2022

Study Completion (Actual)

January 16, 2022

Study Registration Dates

First Submitted

April 26, 2021

First Submitted That Met QC Criteria

April 26, 2021

First Posted (Actual)

April 29, 2021

Study Record Updates

Last Update Posted (Actual)

March 29, 2022

Last Update Submitted That Met QC Criteria

March 13, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-DIAB1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Data will be available upon motivated request to Principal Investigator

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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