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Gengival therapy to prevent bone necrosis

Effect of Injectable Platelet-Rich Fibrin Combined with Non-Surgical Periodontal Therapy in Oncology Patients Undergoing Bisphosphonate Treatment

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-62n9c3p
Enrollment
Unknown
Registered
2025-02-05
Start date
2024-01-15
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

Multiple Myeloma, Bisphosphonate-Associated Osteonecrosis of the Jaw

Interventions

This is a randomized, controlled, single-blind clinical study with cancer patients diagnosed with stage II and III periodontal disease using more than 3 doses of intravenous bisphosphonates. 30 patien

Sponsors

Faculdade de Odontologia de Ribeirão Preto da USP
Lead Sponsor
Faculdade de Odontologia de Ribeirão Preto da USP
Collaborator

Eligibility

Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: Individuals of both sexes, adults or elderly, aged between 18 and 90 years who have undergone cancer treatment and received more than 3 doses of injectable bisphosphonates. Patients with bone metastases and multiple myeloma will be considered

Exclusion criteria

Exclusion criteria: Individuals will be excluded if they present any of the following conditions: (1) physical or mental illness at the time of the exam; (2) neurological disorders; (3) history of uncontrolled seizure or CNS or psychiatric disorder judged by the researchers to be clinically relevant before signing the informed consent form; (4) Who have undergone non-surgical periodontal therapy in the last six months before the study; (5) Patients previously submitted to head and neck radiotherapy

Design outcomes

Primary

MeasureTime frame
It is expected to evaluate whether injectable fibrin-rich plasma associated with non-surgical periodontal therapy (TPNC) is more effective in the treatment of periodontal disease when compared to conventional TPNC in cancer patients using intravenous antiresorptive therapy.

Secondary

MeasureTime frame
It is expected to evaluate the improvement in the clinical and radiographic parameters of periodontal disease through the analysis of the periogram comparatively before and after the proposed treatment of periodontal disease with i-PRF + TPNC, comparing parameters such as reduction in probing depth, bleeding on probing and gain insertion before and after each therapy. In addition to the reduction of pro-inflammatory cytokines in the gingival crevicular fluid, saliva and blood after the treatments carried out in both proposed groups.

Countries

Brazil

Contacts

Public ContactLara Maria Innocentini

Universidade de São Paulo - Ribeirão Preto

linnocentini@usp.br+55 (16)33154041

Outcome results

None listed

Source: REBEC (via WHO ICTRP)