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

Clinical and microbiological evaluation of Bach's Floral and Ozone Therapy in treating chronic periodontitis in Type 2 Diabetic patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-3nxjwjm
Enrollment
Unknown
Registered
2021-05-05
Start date
2020-02-01
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

It is a divided mouth type, in which 20 participants with chronic periodontal disease were selected. After random site selection, patients received conventional periodontal treatment with ultrasound s

Sponsors

Universidade Federal Fluminense – Instituto de Saúde de Nova Friburgo
Lead Sponsor
Universidade Federal Fluminense – Instituto de Saúde de Nova Friburgo
Collaborator

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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).

Countries

Brazil

Contacts

Public ContactComitê de Etica e Pesquisa da FMUSP
cep.fm@usp.br55 11 3893 4401/4407

Outcome results

None listed

Source: REBEC (via WHO ICTRP)