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

NCT07069166 | Recruiting

• 1 other identifier: 2025-PPDM2
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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). 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.

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; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (T0), 3-month follow-up (T1), and 6-month follow-up (T2)

Secondary Outcomes (5)

• Change in Bleeding on Probing (BoP) score

  Baseline (T0), 3-month follow-up (T1), and 6-month follow-up (T2)

• Change in Probing Pocket Depth (PPD) score

  Baseline (T0), 3-month follow-up (T1), and 6-month follow-up (T2)

• Change in Plaque Index (PI) score

  Baseline (T0), 3-month follow-up (T1), and 6-month follow-up (T2)

• Change in glycated hemoglobin (HbA1c) level

  Baseline (T0), 3-month follow-up (T1), and 6-month follow-up (T2)

• Change in patient satisfaction score

  3-month follow-up (T1) and 6-month follow-up (T2)

Study Arms (2)

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.

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.

Drug: Chlorhexidine oral care

Interventions

Para-probiotic oral care DRUG

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.

Para-Probiotic Oral Care Group

Chlorhexidine oral care DRUG

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.

Chlorhexidine Oral Care Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pavia: lead

Study Sites (1)

Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia

Pavia, Lombardy, 27100, Italy

RECRUITING

MeSH Terms

Conditions

Periodontitis; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Andrea Scribante, Associate Professor

  University of Pavia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Scribante, Associate Professor

CONTACT

+39 0382516223; andrea.scribante@unipv.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Principal Investigator

Study Record Dates

• First Submitted: July 5, 2025
• First Posted: July 16, 2025
• Study Start: July 30, 2025
• Primary Completion: June 1, 2026
• Study Completion: June 10, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)