The effect of Metformin on acute inflammation of the body during Periodontal Treatment in non-Diabetic patients

Not Applicable

Recruiting

• Conditions: Periodontitis

• Registration Number: RBR-48rdt69
• Lead Sponsor: uciana Satie Okajima

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-06-14
• Study Completion: 2022-07-30
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Patients requiring periodontal treatment due to stage 3 or 4 generalized periodontitis, grade B or C; both genders; over 18 years old

Exclusion Criteria

Diabetic patients (Glicosilated hemoglobyn greater than 6.5%); pregnant women; patients who are breastfeeding; obese (body mass index greather than 29.9kg/m2); undergoing cancer treatment; taking immunosuppression medication; alcoholics; smokers; with renal failure; liver changes; congestive heart failure; history of acute myocardial infarction less than 6 months ago; respiratory changes (pneumonia, pulmonary embolism, asthma, chronic obstructive pulmonary disease); allergy to any component of the medication formula; when using any medication that may interfere with the protocol of treatment, for example anti-inflammatories or antibiotics will be excluded; individuals who do not agree to sign the informed consent

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement is expected to be found in acute systemic inflammation when patients are treated with metformin. We expect lower levels of the marker High sensitive C-Reactive Protein on metformin treated group when compared to placebo.

Secondary Outcome Measures

Name	Time	Method
We expect lower levels of other systemic inflammation markers on metformin treated group when compared to placebo (RBC Sedimentation Velocity, Interleukin-6, Interleukin-10, Fibrinogen, Tumor Necrosis Factor – alpha). ;Also, we expect lower levels of local inflammatory markers on metformin treated group when compared to placebo, when we analyse the gingival crevicular fluid (verified by analyzing the levels of interleukin-2, interleukin-4, interleukin-6, interleukin-8, interleukin-10, Granulocyte and Macrophage Colony Stimulating Factor and Tumor Necrosis Factor) and periodontal parameters (verified by plaque index, gingival bleeding index, probing depth and clinical attachment level).