Use of Ozonized Water With Toothpaste and Mousse in Non Surgical Periodontal Therapy for Patients With Diabetes Mellitus Type 1: a Randomized Clinical Trial.
Primary Purpose
Diabetes Mellitus With Periodontal Disease
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Peribioma Toothpaste and Mousse
Standard toothpaste
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus With Periodontal Disease focused on measuring ozonized water, glycosylated hemoglobin
Eligibility Criteria
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
Sites / Locations
- Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Trial Group
Control Group
Arm Description
Patients from this group will use Peribioma Toothpaste and Mousse for home oral care.
Patients from this group will use Biorepair Plus Parodontgel for home oral care.
Outcomes
Primary Outcome Measures
Change in Glycosylated Hemoglobin (HbA1c)
Serum levels of glycosylated hemoglobin
Change in CAL - Clinical Attachment Loss
Measurement (in mm) of the position of the gingival margin in relation to the cemento-enamel junction (CEJ).
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.
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.
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%.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04865809
Brief Title
Use of Ozonized Water With Toothpaste and Mousse in Non Surgical Periodontal Therapy for Patients With Diabetes Mellitus Type 1: a Randomized 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.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
May 12, 2021 (Actual)
Primary Completion Date
January 13, 2022 (Actual)
Study Completion Date
January 16, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pavia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus With Periodontal Disease
Keywords
ozonized water, glycosylated hemoglobin
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Trial Group
Arm Type
Experimental
Arm Description
Patients from this group will use Peribioma Toothpaste and Mousse for home oral care.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Patients from this group will use Biorepair Plus Parodontgel for home oral care.
Intervention Type
Other
Intervention Name(s)
Peribioma Toothpaste and Mousse
Intervention Description
Use of Peribioma Toothpaste and Mousse for home oral care.
Intervention Type
Other
Intervention Name(s)
Standard toothpaste
Intervention Description
Use of Biorepair Plus Parodontgel for home oral care
Primary Outcome Measure Information:
Title
Change in Glycosylated Hemoglobin (HbA1c)
Description
Serum levels of glycosylated hemoglobin
Time Frame
Baseline, 3 and 6 months.
Title
Change in CAL - Clinical Attachment Loss
Description
Measurement (in mm) of the position of the gingival margin in relation to the cemento-enamel junction (CEJ).
Time Frame
Baseline, 3 and 6 months.
Title
Change in PI - Plaque Index (Silness and Löe, 1964)
Description
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.
Time Frame
Baseline, 3 and 6 months.
Title
Change in PPD - Probing Pocket Depth
Description
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.
Time Frame
Baseline, 3 and 6 months.
Title
Change in BOP - Bleeding on Probing (percentage)
Description
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%.
Time Frame
Baseline, 3 and 6 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Scribante, DDS, PhD.
Organizational Affiliation
University of Pavia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
City
Pavia
State/Province
Lombardy
ZIP/Postal Code
27100
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Data will be available upon motivated request to Principal Investigator
Learn more about this trial
Use of Ozonized Water With Toothpaste and Mousse in Non Surgical Periodontal Therapy for Patients With Diabetes Mellitus Type 1: a Randomized Clinical Trial.
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