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

Diabetes Mellitus With Periodontal Disease 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04865809
• Other study ID #: 2021-DIAB1
• Status: Completed
• Phase: N/A
• Start date: May 12, 2021
• Est. completion date: January 16, 2022

Study information

• Verified date: March 2022
• Source: University of Pavia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 16, 2022
• Est. primary completion date: January 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus With Periodontal Disease
• Diabetes Mellitus, Type 1
• Periodontal Diseases

Intervention

Other:
• Peribioma Toothpaste and Mousse
Use of Peribioma Toothpaste and Mousse for home oral care.
• Standard toothpaste
Use of Biorepair Plus Parodontgel for home oral care

Locations

Country	Name	City	State
Italy	Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia	Pavia	Lombardy

Sponsors (1)

Lead Sponsor	Collaborator
University of Pavia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Glycosylated Hemoglobin (HbA1c)	Serum levels of glycosylated hemoglobin	Baseline, 3 and 6 months.
Primary	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.
Primary	Change in PI - Plaque Index (Silness and Löe, 1964)	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.	Baseline, 3 and 6 months.
Primary	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.
Primary	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.