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Completed

NCT Number: 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.

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).

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Key information

Conditions

Diabetes Mellitus With Periodontal Disease

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Pavia, Lombardy, 27100, Italy

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Peribioma Toothpaste and Mousse

Other

Use of Peribioma Toothpaste and Mousse for home oral care.

Standard toothpaste

Other

Use of Biorepair Plus Parodontgel for home oral care

Primary outcomes

  1. Change in Glycosylated Hemoglobin (HbA1c)

    Time frame: Baseline, 3 and 6 months.

    Serum levels of glycosylated hemoglobin

  2. 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).

  3. Change in PI - Plaque Index (Silness and Löe, 1964)

    Time frame: Baseline, 3 and 6 months.

    Scoring criteria:

    0 = no plaque;

    • = thin plaque layer at the gingival margin, only detectable by scraping with a probe;
    • = moderate layer of plaque along the gingival margin; interdental spaces free, but plaque is visible to the naked eye;
    • = abundant plaque along the gingival margin; interdental spaces filled with plaque.

  4. 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.

  5. 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%.

Sponsors and collaborators

Lead sponsor

University of Pavia

Other

Registry information

Official study 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.

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 29, 2021
Registry last updated
Mar 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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