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Effects of probiotic use in diabetic patients with periodontal disease

Analysis of the clinical profile of diabetic patients with periodontitis before and after probiotic therapy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-3z3w3n
Enrollment
Unknown
Registered
2020-05-22
Start date
2020-08-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

Interventions

Test group: Initially, 25 patients will be submitted to anamnesis, will receive prophylaxis and / or supragingival scraping ("cleaning" on all teeth) and instruction on oral hygiene. After 7 days, pat
Procedure/surgery
Dietary supplement
Other
E06.721.189.350
G07.203.300.456.500

Sponsors

Universidade de São Paulo
Lead Sponsor
Universidade de São Paulo
Collaborator

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Brazil

Contacts

Public ContactFlávia Furlaneto

Universidade de São Paulo

flafurlaneto@hotmail.com+55 (16) 3602-4140

Outcome results

None listed

Source: REBEC (via WHO ICTRP)