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Cytokine Profiles in Breast Cancer Patients Undergoing Chemotherapy

Effects of Non-surgical Periodontal Treatment on the Gingival Crevicular Fluid Cytokine Profiles in Breast Cancer Patients Undergoing Chemotherapy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03244943
Enrollment
40
Registered
2017-08-10
Start date
2015-08-01
Completion date
2017-07-31
Last updated
2020-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chemotherapy Effect, Mammary Neoplasm, Human, Periodontal Diseases

Brief summary

Aim: This study evaluated the effects of non-surgical periodontal therapy (NSPT) on the cytokine profile and the correlation to clinical parameters of patients undergoing chemotherapy for breast cancer. Materials and methods: 40 patients were allocated: periodontitis patients (P) (n=20) and breast cancer with periodontitis patients (CAN/P) (n=20). The clinical parameters: probing depth (PD), clinical attachment level (CAL), plaque index (PI), Bleeding on probing (BOP) and levels of IFN-γ, IL-4, IL-10, TGF-β, IL-17, IL-2, IL-6, IL-1β and TNF-α in gingival crevicular fluid (GCF) were evaluated at baseline, 45 and 180 days after therapy.

Detailed description

The NSPT, which consisted of subgingival debridement - scaling and root planning (SRP) under local anesthesia. On average, the treatment of the entire oral cavity was completed within four sessions (sessions of 50 minutes). The SRP was performed by one experienced periodontist (KRVV) using Gracey curettes (Hu-Friedy MFG. Co. Inc., Chicago, IL, USA), ultra-sonic devices (Bob-Cat, Dentsply/Cavitron, Long Island City, NY, USA) and, if necessary, with multilaminated drills.

Interventions

The NSPT, which consisted of subgingival debridement - scaling and root planning (SRP) under local anesthesia. On average, the treatment of the entire oral cavity was completed within four sessions (sessions of 50 minutes). The SRP was performed by one experienced periodontist (KRVV) using Gracey curettes (Hu-Friedy MFG. Co. Inc., Chicago, IL, USA), ultra-sonic devices (Bob-Cat, Dentsply/Cavitron, Long Island City, NY, USA) and, if necessary, with multilaminated drills.

Sponsors

University of Sao Paulo
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

40 patients were allocated: periodontitis patients (P) (n=20) and breast cancer with periodontitis patients (CAN/P) (n=20). The clinical parameters: probing depth (PD), clinical attachment level (CAL), plaque index (PI), Bleeding of probing (BOP) and levels of IFN-γ, IL-4, IL-10, TGF-β, IL-17, IL-2, IL-6, IL-1β and TNF-α in gingival crevicular fluid (GCF) were evaluated at baseline, 45 and 180 days after therapy.

Eligibility

Sex/Gender
FEMALE
Age
35 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

* All patients were diagnosed with periodontitis (P) The inclusion criteria were:Loss of clinical insertion (CAL) ≥ 5mm and PD probing depth ≥ 6mm in ≥ 30% of sites; ≥20 teeth; radiographic bone loss that extends to the middle level of the root; presence of supragingival and subgingival calculus according to the severity of periodontal damage. Grade B was assessed indirectly, considering radiographic bone loss in the tooth most affected by dentition as a function of age (0.25 to 1.0).

Exclusion criteria

* 1\) scaling and root planning or antibiotic treatment in the previous 6 months; 2) systemic diseases that could affect the progression of periodontitis (e.g., diabetes, hypertension, cardiovascular diseases); 3) extensive prosthetic involvement; 4) long-term administration of anti-inflammatory medication; 6) smokers and former smokers; 7) pregnancy or lactation; 8) orthodontic therapy; 9) use of mouth rinses containing antimicrobials in the preceding 2 months; 10) patients had previously received chemotherapy or radiotherapy; 11) patients with metastasis and/or patients with neoadjuvant chemotherapy.

Design outcomes

Primary

MeasureTime frameDescription
Cytokinesbaseline, 45 days, 180 daysCytokine levels and changes before and after post treatment

Secondary

MeasureTime frameDescription
Correlation of cytokinesbaseline, 45 days, 180 dayscytokine levels between parameters clinical

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026