Diabetes Mellitus With Periodontal DiseaseNCT04865809
Use of Ozonized Water With Toothpaste and Mousse in Non Surgical Periodontal Therapy for Patients With Diabetes Mellitus Type 1: a Randomized Clinical Trial.
A study testing Peribioma Toothpaste and Mousse and Standard toothpaste in people with Diabetes Mellitus With Periodontal Disease, run by University of Pavia at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus With Periodontal Disease
- What is being tested?
- Peribioma Toothpaste and Mousse and Standard toothpaste
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 12 May 2021to 16 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients suffering from Diabetes Mellitus Type 1
- adult patients
- patients who agreed to participate to the study and that signed the informed consent.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site
Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
Pavia, Lombardy, 27100
About this study
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.
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.
Read more
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).
Read the 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).
- Being tested
- Peribioma Toothpaste and Mousse, Standard toothpaste
- Keywords
- ozonized water, glycosylated hemoglobin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peribioma Toothpaste and MousseOther
Use of Peribioma Toothpaste and Mousse for home oral care.
Standard toothpasteOther
Use of Biorepair Plus Parodontgel for home oral care
| Study group | Role | What they receive |
|---|---|---|
| Trial Group | Experimental | Patients from this group will use Peribioma Toothpaste and Mousse for home oral care. Receives: Other: Peribioma Toothpaste and Mousse |
| Control Group | Active comparator | Patients from this group will use Biorepair Plus Parodontgel for home oral care. Receives: Other: Standard toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Glycosylated Hemoglobin (HbA1c)
Serum levels of glycosylated hemoglobin
Measured: Baseline, 3 and 6 months.
Change in CAL - Clinical Attachment Loss
Measurement (in mm) of the position of the gingival margin in relation to the cemento-enamel junction (CEJ).
Measured: Baseline, 3 and 6 months.
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.
Measured: Baseline, 3 and 6 months.
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.
Measured: Baseline, 3 and 6 months.
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%.
Measured: Baseline, 3 and 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start12 May 2021
- Primary completion13 Jan 2022
- Study completion16 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus With Periodontal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Scribante, University of Pavia
- Investigators
- Andrea Scribante, DDS, PhD., Principal investigator, University of Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04865809
- Sponsor's protocol ID
- 2021-DIAB1
- Status last verified
- Mar 2022
- First submitted
- 26 Apr 2021
- Last updated
- 29 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available upon motivated request to Principal Investigator
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04865809
- Acronym / sponsor ID
- 2021-DIAB1
- Keywords
- ozonized water, glycosylated hemoglobin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Study start
- 12 May 2021 (actual)
- Primary completion
- 13 Jan 2022 (actual)
- Study completion
- 16 Jan 2022 (actual)
- First posted
- 29 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trial Group | Experimental | Other: Peribioma Toothpaste and MoussePatients from this group will use Peribioma Toothpaste and Mousse for home oral care. |
| Control Group | Active comparator | Other: Standard toothpastePatients from this group will use Biorepair Plus Parodontgel for home oral care. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients suffering from Diabetes Mellitus Type 1
- adult patients
- patients who agreed to participate to the study and that signed the informed consent.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peribioma Toothpaste and MousseUse of Peribioma Toothpaste and Mousse for home oral care. | Other | Trial Group |
| Standard toothpasteUse of Biorepair Plus Parodontgel for home oral care | Other | Control Group |
Primary outcome
Change in Glycosylated Hemoglobin (HbA1c)
Time frame: Baseline, 3 and 6 months.
Serum levels of glycosylated hemoglobin
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).
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.
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.
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%.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
- Individual participant dataSharing planned: No. Data will be available upon motivated request to Principal Investigator
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Scribante, DDS, PhD. principal investigator
University of Pavia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peribioma Toothpaste and Mousse and Standard toothpaste in people with Diabetes Mellitus With Periodontal Disease, run by University of Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Glycosylated Hemoglobin (HbA1c) (time frame: Baseline, 3 and 6 months.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2022.