Para-Probiotic Oral Care in Periodontal Patients With Type 2 Diabetes (PPDM2)

University of Pavia

Status: Enrolling

Conditions: Periodontitis; Type 2 Diabetes Mellitus (T2DM)

Treatments: Drug: Para-probiotic oral care; Drug: Chlorhexidine oral care

Study type: Interventional

Funder types: Other

Identifiers

NCT07069166

2025-PPDM2

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Para-Probiotic Oral Care Group

Experimental group

Description:

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.

Treatment:

Drug: Para-probiotic oral care

Chlorhexidine Oral Care Group

Active Comparator group

Description:

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.

Treatment:

Drug: Chlorhexidine oral care