Effect of green propolis on periodontal treatment of type 2 diabetics

Authors
Category Primary study
Registry of TrialsBrazilian Registry of Clinical Trials
Year 2023
INTERVENTION: All participants in this study will undergo scaling and root planning with ultrasound and Gracey curettes, under local anesthesia, and will receive oral hygiene instructions. The scaling of all quadrants will be carried out in two appointments, within a period of 24 hours. The duration of each subgingival instrumentation appointment will be recorded. All participants will receive standardized oral hygiene guidelines, as well as the same toothbrush and toothpaste for home hygiene. The randomization will be performed using opaque envelopes sorting, by a third person. The main researcher will not be aware of the allocation of the patients between the groups, characterizing the study as a double blind. Each group will have 14 participants, previously defined by sample calculation performed using the main outcome, which is the probing pocket depth. In individuals allocated to the test group, non‐surgical periodontal therapy will be performed associated with the prescription of 500 mg of green propolis extract twice a day, totaling 1000 mg daily for a period of 60 days. Each individual will receive one bottle with 120 capsules of green propolis extract. In individuals allocated to the control group, non‐surgical periodontal therapy will be performed without the administration of propolis extract. These individuals will receive one bottle with 120 placebo capsules, similar in color and size to the green propolis extract capsules. The placebo drug will be prescribed for daily use for 60 days. All patients will be advised to take the capsule together with their main meals (lunch and dinner). CONDITION: C18.452.394.750 Chronic Periodontitis; Type 2 Diabetes Mellitus PRIMARY OUTCOME: Probing pocket depht. Evaluate the pocket depth before the treatment and 60 and 90 days after the treatment using periodontal probing with a periodontal probe UNC 15 mm. The expected result is a greater reduction of the probing depth in the test group than in the control group. SECONDARY OUTCOME: Bleeding on probing. Evaluate the percentual of sites with bleeding on probing before the treatment and 60 and 90 days after the treatment using periodontal probing with a periodontal probe UNC 15 mm. The expected result is a greater reduction of the bleeding on probing percentual in the test group than in the control group. C reactive protein (CRP). Evaluate the CRP before the treatment and 60 and 90 days after the treatment through the blood. The expected result is a greater reduction of the CRP measure in the test group than in the control group. Clinical attachment level. Evaluate the clinical attachment level before the treatment and 60 and 90 days after the treatment using periodontal probing with a periodontal probe UNC 15 mm. The expected result is a greater reduction of the clinical attachment level in the test group than in the control group. Fasting blood glucose. Evaluate the fasting blood glucose levels before the treatment and 60 and 90 days after the treatment through the blood. The expected result is a greater reduction of the fasting blood glucose measure in the test group than in the control group. Glycated hemoglobin (HbA1c). Evaluate the glycated hemoglobin levels before the treatment and 60 and 90 days after the treatment through the blood. The expected result is a greater reduction of the glycated hemoglobin measure in the test group than in the control group. INCLUSION CRITERIA: Participants with type 2 diabetes mellitus and periodontitis stages II and III, with a minimum age of 30 years and at least fourteen teeth present in the oral cavity, and who agree to participate in the research through an informed consent form will be included.
Epistemonikos ID: 34d4081f4cefa1845f8ffe398a75c07be78e97f8
First added on: Aug 26, 2024