Para-Probiotic Oral Care in Periodontal Patients With Type 2 Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Para-probiotic oral care, Chlorhexidine oral care.
- Who it may be relevant to
- Registry conditions: Periodontitis, Type 2 Diabetes Mellitus (T2DM). Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Evaluation of Para-Probiotic Toothpaste and Mouthwash on Periodontal Health and Glycemic Control in Diabetic Patients: A Randomized Controlled Trial
Overview
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.
Interventions
- Drug Para-probiotic oral care
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. - Drug Chlorhexidine oral care
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.
Primary outcome measures
- Change in mean Clinical Attachment Level (CAL) [Time frame: Baseline (T0), 3-month follow-up (T1), and 6-month follow-up (T2)]
Secondary outcome measures (5)
- 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)]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Italy · 1 center
- Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinic — Pavia
Identifiers
NCT: NCT07069166 · 2025-PPDM2