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Evaluation of a biotherapeutic as an adjunct treatment for Chronic Periodontitis

Double-blind, placebo-controlled pilot clinical study for clinical evaluation of biotherapeutic as an adjuvant to the treatment of Chronic Periodontitis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-86fwwnn
Enrollment
Unknown
Registered
2025-03-24
Start date
2024-06-19
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

Biotherapics

Interventions

The study was based on a pilot case-control study involving 25 patients, with 16 allocated to the homeopathic biotherapeutics group and 9 to the placebo group. All participants underwent a complete pe

Sponsors

Universidade Veiga de Almeida
Lead Sponsor
Universidade Veiga de Almeida
Collaborator

Eligibility

Age
35 Years to 70 Years

Inclusion criteria

Inclusion criteria: The selected individuals must present a Clinical Attachment Level (CAL) of moderate severity, equal to or greater than three or four millimeters, and severe cases equal to or greater than five millimeters, according to the American Association of Periodontology classification. The probing depth must be present in at least two proximal sites of two non-adjacent teeth. Both sexes

Exclusion criteria

Exclusion criteria: Individuals who have undergone any periodontal treatment in the past twelve months. Presence of aggressive periodontitis. Pregnancy and lactation. Prosthesis users. Medical conditions that may interfere, such as HIV, diabetes, or chronic lung disease. Individuals treated with inhaled corticosteroids, nonsteroidal anti-inflammatory drugs, or antibiotics used in the past six months

Design outcomes

Primary

MeasureTime frame
To evaluate the clinical and microbiological efficacy of ultradiluted biotherapeutic therapy in the treatment of chronic periodontitis, measured by reduction in periodontal pocket depth , gain in clinical attachment level, reduction in visible plaque index and quantitative reduction in periodontopathogenic pathogens.

Secondary

MeasureTime frame
To evaluate the safety and tolerability of ultradiluted biotherapeutic therapy, through: Adverse event monitoring: Recording and classifying the incidence and severity of adverse events related to the intervention during the follow-up period. Additional oral health parameters: Assessment of complementary indicators, such as the presence of inflammatory signs and subjective changes reported by patients

Countries

Brazil

Contacts

Public ContactLeila Mourão

Universidade Veiga de Almeida

leilamourao@hotmail.com+55 (21) 988557576

Outcome results

None listed

Source: REBEC (via WHO ICTRP)