Evaluation of Bach flower and ozone therapy as a complement to periodontal treatment in patients with type 2 diabetes

Not Applicable

• Conditions: Diabetes Mellitus; periodontitis; C07.465.714.533; C18.452.394.750

• Registration Number: RBR-3nxjwjm
• Lead Sponsor: niversidade Federal Fluminense – Instituto de Saúde de Nova Friburgo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-05
• Study Completion: 2021-12-02
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

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

Inclusion Criteria

Criteria for selecting the subjects were as follows: the presence of type 2 diabetes and chronic periodontitis. Diabetes mellitus established according to the American Diabetes Academy, with Hba1c higher than or equal to 6.5%, fasting blood glucose> 126 mg/dl. Patients diagnosed with diabetes and treatment with an endocrinologist using metformin, with Hba1c and fasting blood glucose within the normal range were also accepted, that is, Hba1c <6.5 and fasting blood glucose 100 mg/dl. Chronic periodontitis, established according to new criterion, probing depth (PD) with 3 mm on two or more teeth.

Exclusion Criteria

The subjects were excluded when: they showed hypersensitivity to the floral components and any evidence of systemic factors that modify periodontal disease, except for diabetes mellitus; they may directly interfere in completing the work (bias). The factors described in the literature include osteoporosis types I and II, alcoholism, acquired or induced immunosuppression, any change described in the novel as a potential modifier of the periodontal disease profile, and physical/emotional stress drugs that influence periodontal tissues. Samples from pregnant or lactating women, individuals who have taken antibiotics in the past six months, clinical manifestations of oral candidiasis, anti-inflammatories or hormone replacement therapy, and who have received periodontal treatment in the last six months before the procedure will be excluded.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
It is expected to find greater effectiveness of inhibition of periodontopathogens in the test groups. This outcome will be evaluated through microbiological parameters, presence of Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis and Tannerella forsythia, C. albicans, C. dubliniensis, C. glabrata and C. Tropicalis through qualitative analysis of the polymerase chain reaction.;It is expected to find improvement in periodontal clinical parameters after the three months. This outcome will be assessed using periodontal clinical parameters: Plaque Index (PI), Gingival Index (GI), Probing Depth (PD), Gingival Recession (GR), and Clinical Attachment Level (CAL).