Use of Ozonized Water With Toothpaste and Mousse in Non Surgical Periodontal Therapy for Patients With Diabetes Mellitus Type 1: a Randomized Clinical Trial.
NCT ID: NCT04865809
Last Updated: 2022-03-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2021-05-12
2022-01-16
Brief Summary
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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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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Trial Group
Patients from this group will use Peribioma Toothpaste and Mousse for home oral care.
Peribioma Toothpaste and Mousse
Use of Peribioma Toothpaste and Mousse for home oral care.
Control Group
Patients from this group will use Biorepair Plus Parodontgel for home oral care.
Standard toothpaste
Use of Biorepair Plus Parodontgel for home oral care
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* adult patients
* patients who agreed to participate to the study and that signed the informed consent.
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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University of Pavia
OTHER
Responsible Party
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Andrea Scribante
Research Resident, Principal Investigator
Principal Investigators
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Andrea Scribante, DDS, PhD.
Role: PRINCIPAL_INVESTIGATOR
University of Pavia
Locations
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Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
Pavia, Lombardy, Italy
Countries
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Other Identifiers
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2021-DIAB1
Identifier Type: -
Identifier Source: org_study_id
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