PeriodontitisPPDM2NCT07069166
Para-Probiotic Oral Care in Periodontal Patients With Type 2 Diabetes
A study testing Para-probiotic oral care and Chlorhexidine oral care in people with Periodontitis and Type 2 Diabetes Mellitus (T2DM), run by University of Pavia at 1 site in Italy.
Trial summary
This randomized controlled clinical trial aims to evaluate the effectiveness of a para-probiotic-based oral care protocol in improving periodontal health and glycemic control in patients with type 2 diabetes mellitus (T2DM). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Periodontitis, Type 2 Diabetes Mellitus (T2DM)
- What is being tested?
- Para-probiotic oral care and Chlorhexidine oral care
- 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
- 30 Jul 2025to 10 Jun 2026
- 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
- Age between 18 and 70 years
- Diagnosis of periodontitis (Stage II or III; Grade B or C)
- Presence of at least one periodontal pocket per side of the mouth, with a maximum of 20 teeth presenting pathological probing depths
- Presence of both single- and multi-rooted teeth
- Type 2 diabetes mellitus diagnosed at least one year prior to enrollment
- Good general health status and ability to comply with study protocol
- Written informed consent provided
Who cannot join
- Presence of cardiac pacemakers
- History of neurological disorders
- History of psychiatric disorders
- Current pregnancy or breastfeeding
- Steroid-induced diabetes mellitus
- Inability or unwillingness to attend follow-up visits or adhere to home oral care instructions
Trial locations and contacts
1 site in 1 country.
Italy1 site
Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia
Pavia, Lombardy, 27100
About this study
Official title: Evaluation of Para-Probiotic Toothpaste and Mouthwash on Periodontal Health and Glycemic Control in Diabetic Patients: A Randomized Controlled Trial
This randomized controlled clinical trial aims to evaluate the effectiveness of a para-probiotic-based oral care protocol in improving periodontal health and glycemic control in patients with type 2 diabetes mellitus (T2DM).
A total of 40 adult patients (aged 18-70) with diagnosed periodontitis and T2DM will be enrolled and randomly assigned to two treatment groups. Both groups will receive standard non-surgical periodontal therapy. The test group will use para-probiotic toothpaste and mouthwash (Biorepair Plus Parodontogel and Biorepair Plus mouthwash) twice daily for 15 days after each recall visit, while the control group will use toothpaste and mouthwash containing 0.20% chlorhexidine on the same schedule.
Read more
Clinical evaluations will be conducted at baseline (T0), 3 months (T1), and 6 months (T2), assessing key periodontal parameters including clinical attachment level (CAL), bleeding on probing (BoP), probing pocket depth (PPD), plaque index (PI), and glycemic control via hemoglobin A1c (HbA1c) levels. Patient satisfaction with treatment will be assessed using a questionnaire at T1 and T2.
The primary objective is to evaluate the change in CAL from baseline to 6 months. Secondary objectives include the evaluation of changes in BoP, PPD, PI, HbA1c, and patient-reported satisfaction.
This study seeks to determine whether para-probiotic oral care products can offer clinical benefits for periodontal disease management and systemic glycemic control in diabetic patients, potentially serving as a natural adjunct to conventional periodontal therapy.
- Conditions
- Periodontitis, Type 2 Diabetes Mellitus (T2DM)
- Being tested
- Para-probiotic oral care, Chlorhexidine oral care
- Keywords
- Para-probiotics, Periodontitis, Type 2 Diabetes Mellitus, Biorepair, Oral microbiota, Glycated hemoglobin (HbA1c), Chlorhexidine, Non-surgical periodontal therapy, Randomized controlled trial
- Medical subject headings
- Periodontitis, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Para-probiotic oral careDrug
This intervention includes the home use of a para-probiotic-based toothpaste (Biorepair Plus Parodontogel) and mouthwash (Biorepair Plus with para-probiotics), applied twice daily for 15 days after each recall visit, over a 6-month period. The products contain microRepair® (zinc hydroxyapatite), lactoferrin, zinc PCA, and para-probiotic extracts aimed at modulating the oral microbiota and improving periodontal health.
Chlorhexidine oral careDrug
This intervention includes the home use of toothpaste and mouthwash containing 0.20% chlorhexidine digluconate, applied twice daily for 15 days after each recall visit, over a 6-month period. Chlorhexidine is used for its antimicrobial properties to control dental plaque and gingival inflammation.
| Study group | Role | What they receive |
|---|---|---|
| Para-Probiotic Oral Care Group | Experimental | Participants receive standard non-surgical periodontal therapy and use para-probiotic toothpaste (Biorepair Plus Parodontogel) and para-probiotic mouthwash (Biorepair Plus), twice daily for 15 days after each recall visit, over a 6-month period. Receives: Drug: Para-probiotic oral care |
| Chlorhexidine Oral Care Group | Active comparator | Participants receive standard non-surgical periodontal therapy and use toothpaste and mouthwash containing 0.20% chlorhexidine, twice daily for 15 days after each recall visit, over a 6-month period. Receives: Drug: Chlorhexidine oral care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean Clinical Attachment Level (CAL)
This outcome measures the difference in mean Clinical Attachment Level (CAL) between baseline and the 6-month follow-up in patients with periodontitis and type 2 diabetes mellitus, randomized to receive either para-probiotic-based or chlorhexidine-based oral care after standard non-surgical periodontal therapy. CAL will be assessed in millimeters at six sites per tooth (mesio-buccal, buccal, disto-buccal, mesio-lingual, lingual, disto-lingual) using a calibrated manual periodontal probe. Measurements will be performed at three predefined timepoints: at baseline (T0, Day 0) before the start of treatment; at three months (T1, approximately Day 90) as an intermediate evaluation; and at six months (T2, approximately Day 180), which represents the final endpoint. The primary endpoint is defined as the difference in mean CAL per patient between the baseline and the 6-month follow-up.
Measured: Baseline (T0), 3-month follow-up (T1), and 6-month follow-up (T2)
Secondary outcomes (5)
Change in Bleeding on Probing (BoP) score
This outcome measures the variation in Bleeding on Probing (BoP) between baseline and follow-up visits in patients receiving either para-probiotic or chlorhexidine oral care. BoP is assessed using a calibrated periodontal probe inserted into the gingival sulcus at six sites per tooth. A site is considered positive if bleeding occurs within 15 seconds of probing. The BoP score is expressed as the percentage of bleeding sites out of the total number of sites examined for each patient. Higher scores indicate a greater degree of gingival inflammation. Measurements will be recorded at baseline (T0), 3-month follow-up (T1), and 6-month follow-up (T2). The endpoint is defined as the change in mean BoP score between T0 and T2.
Measured: Baseline (T0), 3-month follow-up (T1), and 6-month follow-up (T2)
Change in Probing Pocket Depth (PPD) score
This outcome assesses the variation in Probing Pocket Depth (PPD) between baseline and follow-up visits in patients receiving either para-probiotic or chlorhexidine oral care. PPD is measured in millimeters using a calibrated UNC-15 periodontal probe inserted into the gingival sulcus at six sites per tooth. The depth is recorded as the distance from the gingival margin to the bottom of the periodontal pocket. The PPD score is calculated as the mean depth of all recorded sites per patient. Higher values indicate more severe periodontal involvement. Measurements will be taken at baseline (T0), 3-month follow-up (T1), and 6-month follow-up (T2). The endpoint is defined as the change in mean PPD score between T0 and T2.
Measured: Baseline (T0), 3-month follow-up (T1), and 6-month follow-up (T2)
Change in Plaque Index (PI) score
This outcome evaluates the variation in the Plaque Index (PI) score between baseline and follow-up in both study groups. PI is determined by visually assessing the presence of dental plaque on four surfaces per tooth (distal, mesial, buccal, and lingual/palatal) after disclosing agent application. The score is expressed as the percentage of plaque-positive sites over the total number of examined sites per patient. Higher scores indicate poorer oral hygiene and greater plaque accumulation. Measurements are collected at baseline (T0), 3-month follow-up (T1), and 6-month follow-up (T2). The endpoint is the change in mean PI score between T0 and T2.
Measured: Baseline (T0), 3-month follow-up (T1), and 6-month follow-up (T2)
Change in glycated hemoglobin (HbA1c) level
This outcome measures the variation in glycated hemoglobin (HbA1c) levels between baseline and follow-up in patients undergoing para-probiotic or chlorhexidine oral care. HbA1c is measured using standardized blood assays and reflects average blood glucose control over the previous 8-12 weeks. The value is expressed as a percentage of total hemoglobin. Lower values indicate better glycemic control. Measurements are performed at baseline (T0), 3-month follow-up (T1), and 6-month follow-up (T2). The endpoint is the change in mean HbA1c level between T0 and T2.
Measured: Baseline (T0), 3-month follow-up (T1), and 6-month follow-up (T2)
Change in patient satisfaction score
This outcome evaluates the variation in patient-reported satisfaction with the oral care protocol. Satisfaction is assessed using a structured, self-administered questionnaire consisting of Likert-scale items (ranging from 1 = very dissatisfied to 5 = very satisfied) regarding taste, ease of use, perceived effectiveness, and overall comfort. The total score is calculated as the mean of all items per patient. Higher scores reflect greater satisfaction. The questionnaire is administered at 3-month follow-up (T1) and 6-month follow-up (T2). The endpoint is the change in mean satisfaction score between T1 and T2.
Measured: 3-month follow-up (T1) and 6-month follow-up (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start30 Jul 2025
- Primary completion1 Jun 2026
- Study completion10 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies 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
- None (open label)
- 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, Associate Professor, Principal investigator, University of Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07069166
- Sponsor's protocol ID
- 2025-PPDM2
- Acronym
- PPDM2
- Status last verified
- Oct 2026
- First submitted
- 5 Jul 2025
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available upon motivated request to the corresponding authors.
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Para-Probiotic Toothpaste and Mouthwash on Periodontal Health and Glycemic Control in Diabetic Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07069166
- Acronym / sponsor ID
- PPDM2 / 2025-PPDM2
- Conditions
- Periodontitis, Type 2 Diabetes Mellitus (T2DM)
- Keywords
- Para-probiotics, Periodontitis, Type 2 Diabetes Mellitus, Biorepair, Oral microbiota, Glycated hemoglobin (HbA1c), Chlorhexidine, Non-surgical periodontal therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Study start
- 30 Jul 2025 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 10 Jun 2026 (actual)
- First posted
- 16 Jul 2025 (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.
This randomized controlled clinical trial aims to evaluate the effectiveness of a para-probiotic-based oral care protocol in improving periodontal health and glycemic control in patients with type 2 diabetes mellitus (T2DM).
A total of 40 adult patients (aged 18-70) with diagnosed periodontitis and T2DM will be enrolled and randomly assigned to two treatment groups. Both groups will receive standard non-surgical periodontal therapy. The test group will use para-probiotic toothpaste and mouthwash (Biorepair Plus Parodontogel and Biorepair Plus mouthwash) twice daily for 15 days after each recall visit, while the control group will use toothpaste and mouthwash containing 0.20% chlorhexidine on the same schedule.
Clinical evaluations will be conducted at baseline (T0), 3 months (T1), and 6 months (T2), assessing key periodontal parameters including clinical attachment level (CAL), bleeding on probing (BoP), probing pocket depth (PPD), plaque index (PI), and glycemic control via hemoglobin A1c (HbA1c) levels. Patient satisfaction with treatment will be assessed using a questionnaire at T1 and T2.
The primary objective is to evaluate the change in CAL from baseline to 6 months. Secondary objectives include the evaluation of changes in BoP, PPD, PI, HbA1c, and patient-reported satisfaction.
This study seeks to determine whether para-probiotic oral care products can offer clinical benefits for periodontal disease management and systemic glycemic control in diabetic patients, potentially serving as a natural adjunct to conventional periodontal therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Para-Probiotic Oral Care Group | Experimental | Drug: Para-probiotic oral careParticipants receive standard non-surgical periodontal therapy and use para-probiotic toothpaste (Biorepair Plus Parodontogel) and para-probiotic mouthwash (Biorepair Plus), twice daily for 15 days after each recall visit, over a 6-month period. |
| Chlorhexidine Oral Care Group | Active comparator | Drug: Chlorhexidine oral careParticipants receive standard non-surgical periodontal therapy and use toothpaste and mouthwash containing 0.20% chlorhexidine, twice daily for 15 days after each recall visit, over a 6-month period. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age between 18 and 70 years
- Diagnosis of periodontitis (Stage II or III; Grade B or C)
- Presence of at least one periodontal pocket per side of the mouth, with a maximum of 20 teeth presenting pathological probing depths
- Presence of both single- and multi-rooted teeth
- Type 2 diabetes mellitus diagnosed at least one year prior to enrollment
Key exclusion criteria (6 listed)
- Presence of cardiac pacemakers
- History of neurological disorders
- History of psychiatric disorders
- Current pregnancy or breastfeeding
- Steroid-induced diabetes mellitus
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 |
|---|---|---|
| Para-probiotic oral careThis intervention includes the home use of a para-probiotic-based toothpaste (Biorepair Plus Parodontogel) and mouthwash (Biorepair Plus with para-probiotics), applied twice daily for 15 days after each recall visit, over a 6-month period. The products contain microRepair® (zinc hydroxyapatite), lactoferrin, zinc PCA, and para-probiotic extracts aimed at modulating the oral microbiota and improving periodontal health. | Drug | Para-Probiotic Oral Care Group |
| Chlorhexidine oral careThis intervention includes the home use of toothpaste and mouthwash containing 0.20% chlorhexidine digluconate, applied twice daily for 15 days after each recall visit, over a 6-month period. Chlorhexidine is used for its antimicrobial properties to control dental plaque and gingival inflammation. | Drug | Chlorhexidine Oral Care Group |
Primary outcome
Change in mean Clinical Attachment Level (CAL)
Time frame: Baseline (T0), 3-month follow-up (T1), and 6-month follow-up (T2)
This outcome measures the difference in mean Clinical Attachment Level (CAL) between baseline and the 6-month follow-up in patients with periodontitis and type 2 diabetes mellitus, randomized to receive either para-probiotic-based or chlorhexidine-based oral care after standard non-surgical periodontal therapy. CAL will be assessed in millimeters at six sites per tooth (mesio-buccal, buccal, disto-buccal, mesio-lingual, lingual, disto-lingual) using a calibrated manual periodontal probe. Measurements will be performed at three predefined timepoints: at baseline (T0, Day 0) before the start of treatment; at three months (T1, approximately Day 90) as an intermediate evaluation; and at six months (T2, approximately Day 180), which represents the final endpoint. The primary endpoint is defined as the difference in mean CAL per patient between the baseline and the 6-month follow-up.
5 secondary outcomes
Change in Bleeding on Probing (BoP) score
Time frame: Baseline (T0), 3-month follow-up (T1), and 6-month follow-up (T2)
Change in Probing Pocket Depth (PPD) score
Time frame: Baseline (T0), 3-month follow-up (T1), and 6-month follow-up (T2)
Change in Plaque Index (PI) score
Time frame: Baseline (T0), 3-month follow-up (T1), and 6-month follow-up (T2)
Change in glycated hemoglobin (HbA1c) level
Time frame: Baseline (T0), 3-month follow-up (T1), and 6-month follow-up (T2)
Change in patient satisfaction score
Time frame: 3-month follow-up (T1) and 6-month follow-up (T2)
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 6 Oct 2026.
- Individual participant dataSharing planned: No. Data will be available upon motivated request to the corresponding authors.
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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, Associate Professor 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 Para-probiotic oral care and Chlorhexidine oral care in people with Periodontitis and Type 2 Diabetes Mellitus (T2DM), 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 7 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 6 Oct 2026. 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 mean Clinical Attachment Level (CAL) (time frame: Baseline (T0), 3-month follow-up (T1), and 6-month follow-up (T2)). 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 Oct 2026.