Type 1 DiabetesNCT05569525
Type I Diabetes and Non-surgical Periodontal Treatment
A study testing Non-surgical periodontal therapy in people with Type 1 Diabetes and Periodontitis, run by University of Florence at 1 site in Italy.
Trial summary
Current evidence suggests a bidirectional association between periodontitis and diabetes. Periodontal therapy improves short term HbA1c levels and is safe to perform. Most studies are focused on type 2 Diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes, Periodontitis, Periodontal Diseases
- What is being tested?
- Non-surgical periodontal therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 6 Nov 2022to 10 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Type 1 diabetes
- Patients under treatment in the department of Diabetology of AOU Careggi having a microinfusor for continuous subcutaneous insulin infusion (CSII) and a Flash Glucose Monitoring (FGM) device
- Diagnosis of periodontitis (all stages and grades)
Who cannot join
- Contraindications for non-surgical periodontal therapy
- Pregnancy
- History of other systemic disease (cancer, HIV, bone metabolic dysease, Head and Neck Radiotherapy, Immunosuppressive/modulating therapy)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Non-surgical Periodontal Therapy on the Glycemic Variability of Periodontal Patients Affected by Type I Diabetes. a Randomized Clinical Trial.
Current evidence suggests a bidirectional association between periodontitis and diabetes. Periodontal therapy improves short term HbA1c levels and is safe to perform. Most studies are focused on type 2 Diabetes. Literature about the correlation between periodontitis and type 1 diabetes is scarce, since no randomized clinical trials have been performed.
The objective of the present clinical investigation is to evaluate the effects of nonsurgical treatment of periodontal disease on glycemic variability in patients with type 1 diabetes (T1DM). The hypothesis is that nonsurgical periodontal therapy affects glycemic variability in terms of time spent in hyperglycemia.
- Conditions
- Type 1 Diabetes, Periodontitis, Periodontal Diseases, Diabetes, Diabetes Mellitus, Diabetes Mellitus, Type 1
- Being tested
- Non-surgical periodontal therapy
- Medical subject headings
- Diabetes Mellitus, Type 1, Periodontitis, Periodontal Diseases, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-surgical periodontal therapyProcedure or surgery
Non-surgical periodontal therapy according to the full-mouth debridement protocol.
| Study group | Role | What they receive |
|---|---|---|
| Test | Experimental | Patients receiving non-surgical periodontal treatment within 1 week from enrollment. Receives: Procedure: Non-surgical periodontal therapy |
| Control | Active comparator | Patients receiving non-surgical periodontal treatment 6 months after the enrollment. Receives: Procedure: Non-surgical periodontal therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycated hemoglobin (HbA1c)
Glycated hemoglobin (HbA1c) to evaluate glycemic variability measured as a percentage (%).
Measured: 6 months after the non-surgical periodontal treatment
Secondary outcomes (2)
Standard Deviation (SD) of glycaemia
Standard Deviation: the spread of glucose readings around the average (mg/dl)
Measured: 6 months after the non-surgical periodontal treatment
Glucose coefficient of variability (CV)
CV is a calculation: dividing the SD by the mean glucose and multiplying by 100 to get a percentage (%).
Measured: 6 months after the non-surgical periodontal treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study start6 Nov 2022
- Primary completion10 Nov 2023
- Study completion10 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florence
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Francesco Cairo, University of Florence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05569525
- Sponsor's protocol ID
- DIODO
- Status last verified
- Dec 2024
- First submitted
- 3 Oct 2022
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Non-surgical Periodontal Therapy on the Glycemic Variability of Periodontal Patients Affected by Type I Diabetes. a Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT05569525
- Acronym / sponsor ID
- DIODO
- Conditions
- Type 1 Diabetes, Periodontitis, Periodontal Diseases, Diabetes, Diabetes Mellitus, Diabetes Mellitus, Type 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of FlorenceUniversity, hospital or other
- Study start
- 6 Nov 2022 (actual)
- Primary completion
- 10 Nov 2023 (actual)
- Study completion
- 10 Dec 2025 (estimated)
- First posted
- 6 Oct 2022 (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.
Current evidence suggests a bidirectional association between periodontitis and diabetes. Periodontal therapy improves short term HbA1c levels and is safe to perform. Most studies are focused on type 2 Diabetes. Literature about the correlation between periodontitis and type 1 diabetes is scarce, since no randomized clinical trials have been performed.
The objective of the present clinical investigation is to evaluate the effects of nonsurgical treatment of periodontal disease on glycemic variability in patients with type 1 diabetes (T1DM). The hypothesis is that nonsurgical periodontal therapy affects glycemic variability in terms of time spent in hyperglycemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test | Experimental | Procedure: Non-surgical periodontal therapyPatients receiving non-surgical periodontal treatment within 1 week from enrollment. |
| Control | Active comparator | Procedure: Non-surgical periodontal therapyPatients receiving non-surgical periodontal treatment 6 months after the enrollment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of Type 1 diabetes
- Patients under treatment in the department of Diabetology of AOU Careggi having a microinfusor for continuous subcutaneous insulin infusion (CSII) and a Flash Glucose Monitoring (FGM) device
- Diagnosis of periodontitis (all stages and grades)
Key exclusion criteria (3 listed)
- Contraindications for non-surgical periodontal therapy
- Pregnancy
- History of other systemic disease (cancer, HIV, bone metabolic dysease, Head and Neck Radiotherapy, Immunosuppressive/modulating therapy)
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 |
|---|---|---|
| Non-surgical periodontal therapyNon-surgical periodontal therapy according to the full-mouth debridement protocol. | Procedure or surgery | Control, Test |
Primary outcome
Glycated hemoglobin (HbA1c)
Time frame: 6 months after the non-surgical periodontal treatment
Glycated hemoglobin (HbA1c) to evaluate glycemic variability measured as a percentage (%).
2 secondary outcomes
Standard Deviation (SD) of glycaemia
Time frame: 6 months after the non-surgical periodontal treatment
Glucose coefficient of variability (CV)
Time frame: 6 months after the non-surgical periodontal treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-surgical periodontal therapy in people with Type 1 Diabetes and Periodontitis, run by University of Florence 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 3 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: under way, not looking for participants, as of the sponsor's last update on 6 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
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?
Glycated hemoglobin (HbA1c) (time frame: 6 months after the non-surgical periodontal treatment). 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 6 Dec 2024.