Effects of probiotic use in diabetic patients with periodontal disease

Not Applicable

• Conditions: Diabetes Mellitus; Periodontal Diseases; C18.452.394.750; C07.465.714.533

• Registration Number: RBR-3z3w3n
• Lead Sponsor: niversidade de São Paulo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-22
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Presence of at least 15 natural teeth, excluding third molars and teeth indicated for extraction; diagnosis of generalized stage III grade C periodontitis, with more than 30% of the sites with probing depth and clinical level of insertion greater than or equal to 4 mm and bleeding on probing of at least 30% of the teeth; presence of type II diabetes mellitus diagnosed at least 5 years ago, with glycated hemoglobin levels between 7% and 11%, treatment with diet and supplementation with insulin or hypoglycemic agents; presence of a good state of general health with the exception of diabetes mellitus.

Exclusion Criteria

Presence of other systemic conditions, with the exception of diabetes mellitus, which can affect the progression of periodontitis or the response to its treatment; long-term administration of anti-inflammatory or immunosuppressive medication; periodontal treatment and / or use of antimicrobials in the last 6 months; use of probiotics in the last 6 months; continuous use of mouthwashes containing antimicrobial agents in the last 6 months; need for prophylactic antibiotic therapy for routine dental procedures; extensive prosthetic rehabilitation; tobacco consumption in the last 5 years; pregnancy and lactation; diabetic complications, such as nephropathy, neuropathy, and peripheral cardiovascular and vascular diseases.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Expected outcome: Reduction in loss of clinical insertion level; assessed by measuring the clinical level of insertion in millimeters, which corresponds to the distance between the cemento-enamel junction and the bottom of the periodontal pocket; considering a variation of at least 15% in the data collected at the beginning and at the end of the study.

Secondary Outcome Measures

Name	Time	Method
Expected outcome 1: Reduction in drilling depth; measured in millimeters from the gingival margin to the bottom of the periodontal pocket; at the beginning and end of the study.;Expected outcome 2: Reduction in bleeding on probing; assessed dichotomously at 6 sites per tooth; at the beginning and end of the study.;Expected outcome 3: Reduction in glycated hemoglobin levels; assessed through blood analysis; at the beginning and end of the study.