Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 4:39 PM
Ignite Modification Date:
2025-12-24 @ 4:39 PM
NCT ID:
NCT07069166
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.
Study:
NCT07069166
Study Brief:
Protocol Section:
NCT07069166