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

Study acronym: PPDM2
StatusCompleted
PhaseNot applicable
Started
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Record History

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  1. Minor Trial completed
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: details revised at 5 of 5 entries
    • Site details revised
  2. Minor Primary completion date: Jan 30, 2026 to Jun 1, 2026
    • Study completion date: Feb 15, 2026 to Jun 10, 2026
    v3
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07069166
Lead Sponsor University of Pavia
Conditions
(from sponsor)
Periodontitis, Type 2 Diabetes Mellitus (T2DM)
Related terms Diabetes Mellitus, Type 2, Periodontitis
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov