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

Evaluation of the effect of glycemic control on acute systemic inflammation using oral Metformin during Periodontal Treatment in non-Diabetic patients. Pilot randomized clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-48rdt69
Enrollment
Unknown
Registered
2022-06-14
Start date
2021-05-20
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

Periodontitis

Interventions

20 patients in good health and diagnosed with Generalized Periodontitis stage 3 or 4 Grade B or C, with a demand for non-surgical periodontal treatment, will be selected for the research.Prior to the
will have the glucose level evaluated by the home glucose test (filter paper strips and lancet) before the drug intervention, on the day of the periodontal intervention and 1, 3 and 7 days after the p
will receive a diary to fill in with the diet for the 10 days of treatment
will undergo collection of gingival crevicular fluid through filter paper strips (before drug intervention, 1, 3 and 7 days after periodont
E06.721.189.350 E06.761.227.350

Sponsors

Luciana Satie Okajima
Lead Sponsor
Faculdade São Leopoldo Mandic
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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).

Countries

Brazil

Contacts

Public ContactLuciana Okajima

Centro de Pós-Graduação São Leopoldo Mandic/Faculdade de Odontologia

luciana.okajima@slmandic.edu.br+55(19)32113600

Outcome results

None listed

Source: REBEC (via WHO ICTRP)