Assessment of Periodontal Therapy and Biofilm Management in Breast Cancer

Not Applicable

Completed

• Conditions: Breast Cancer; Periodontal; Gingivitis
• Interventions: Other: Basic Periodontal Therapy

• Registration Number: NCT06212908
• Lead Sponsor: University of Sao Paulo

Brief Summary

Objective: To evaluate the impact of chemotherapy on periodontal conditions, hematology, and salivary flow in patients with breast cancer and gingivitis, after basic periodontal therapy (BPT).

Methods: They were divided into patients with breast cancer and gingivitis (BC/G =20); and patients without cancer with gingivitis (G=20). Clinical parameters \[Plaque Index (PI), bleeding on probing (BOP), Probing Depth (PS), Clinical Attachment Level (CAL)\], hematological parameters (complete blood count), and salivary flow were evaluated at baseline, 6, 12 and 24 weeks.

Detailed Description

Objective: To evaluate the impact of chemotherapy on periodontal conditions, hematology, and salivary flow in patients with breast cancer and gingivitis, after basic periodontal therapy (BPT).

Methods: They were divided into patients with breast cancer and gingivitis (BC/G =20); and patients without cancer with gingivitis (G=20). Clinical parameters \[Plaque Index (PI), bleeding on probing (BOP), Probing Depth (PS), Clinical Attachment Level (CAL)\], hematological parameters (complete blood count), and salivary flow were evaluated at baseline, 6, 12 and 24 weeks.

Study Timeline

• Study Start: 2012-09-18
• Primary Completion: 2015-12
• Study Completion: 2016-12
• Study First Submitted: 2023-12-30
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-15
• Last Update Submitted: 2024-01-15
• Study First Posted: 2024-01-19
• Last Update Posted: 2024-01-19

Recruitment & Eligibility

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

Inclusion Criteria

Not provided

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Exclusion Criteria

1. systemic diseases (e.g. diabetes, cardiovascular diseases) or autoimmune diseases in addition to cancer; 2) patients with periodontitis; 3) use of any medication that could interfere with periodontal aspects; 4) smokers; 5) Pregnant or lactating patients.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Breast cancer	Basic Periodontal Therapy	The division was made into 2 groups: Patients with breast cancer and gingivitis (BC/G) (n=20); and control patients with gingivitis only (G) (n=20). Clinical periodontal examinations were carried out by a single trained and calibrated examiner. Clinical periodontal, hematological and salivary flow parameters were assessed at baseline, 6 weeks, 12 and 24 weeks.

Primary Outcome Measures

Name	Time	Method
Periodontal conditions	before and after post treatment (baseline, 6 weeks, 12 and 24 weeks)	The plaque index (PI) was determined by analyzing the presence or absence of biofilm on the gingival margin, expressed as a percentage of surfaces with biofilm Bleeding on probing (BOP) was determined by detecting the presence or absence of bleeding, expressed as the percentage of bleeding surfaces.; The probing depth (PD/mm) was expressed in millimeters, measured from the gingival margin to the bottom of the gingival sulcus.; The clinical attachment level (CAL/mm) was expressed in millimeters, measured from the cementoenamel junction to the most apical portion of the gingival sulcus.; Both BOP, PD, CAL were evaluated at six locations per tooth, i.e., three on the buccal surface and three on the lingual or palatal surface.; Periodontal parameters (BOP, PD, CAL and PI ) are evaluated together or combined to perform periodontal diagnosis

Secondary Outcome Measures

Name	Time	Method
Salivary Flow	before and after post treatment (baseline, 6 weeks, 12 and 24 weeks)	The salivary flow rate was expressed in milliliters per minute (mL/min). Periodontal parameters and salivary flow will be combined to assess oral health.