Cytokine Profiles in Breast Cancer Patients Undergoing Chemotherapy

Not Applicable

Completed

• Conditions: Periodontal Diseases; Chemotherapy Effect; Mammary Neoplasm, Human
• Interventions: Procedure: Non surgical periodontal Treatment

• Registration Number: NCT03244943
• Lead Sponsor: University of Sao Paulo

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2015-08-01
• Primary Completion: 2016-12-12
• Study Completion: 2017-07-31
• Status Verified: 2017-08
• Study First Submitted: 2017-08-04
• Study First Submitted QC: 2017-08-08
• Study First Posted: 2017-08-10
• Last Update Submitted: 2020-06-18
• Last Update Posted: 2020-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non surgical periodontal treatment	Non surgical periodontal Treatment	The NSPT, which consisted of subgingival debridement - scaling and root planning (SRP) under local anesthesia.

Primary Outcome Measures

Name	Time	Method
Cytokines	baseline, 45 days, 180 days	Cytokine levels and changes before and after post treatment

Secondary Outcome Measures

Name	Time	Method
Correlation of cytokines	baseline, 45 days, 180 days	cytokine levels between parameters clinical