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Completed

NCT Number: NCT06212908

Assessment of Periodontal Therapy and Biofilm Management in Breast Cancer

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Gingival Diseases Gingivitis Infections Mouth Diseases Neoplasms Neoplasms by Site Periodontal Periodontal Diseases Skin Diseases Skin and Connective Tissue Diseases Stomatognathic Diseases

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • All patients were diagnosed with localized gingivitis (G) The inclusion criteria were: At least 15 teeth; no loss of attachment and probing depth ≤ 3mm; bleeding on probing ≥ 10% of sites, no radiographic bone loss.

Exclusion criteria

  • 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.

Treatment and study plan

Basic Periodontal Therapy

Other

All patients received oral hygiene instructions (interproximal cleaning with floss and interdental brushes, brushing instructions on the Bass technique). The patients were also encouraged to brush the back of the tongue once a day. Subsequently, all patients underwent supragingival scaling, prophylaxis, and polishing. Supragingival scaling was performed using manual instruments (Gracey curettes) and an ultrasonic device.

Other names: Biofilm control

Primary outcomes

  1. Periodontal conditions

    Time frame: 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 outcomes

  1. Salivary Flow

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Collaborators

  • Daniela Bazan Palioto

Registry information

Official study title

Integrating Periodontal Therapy and Biofilm Management Into Breast Cancer Patients' Care: Periodontal, Hematological and Salivary Parameters Assessment Before and During Chemotherapy

Acronym: BREASTCANCER

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Jan 19, 2024
Registry last updated
Jan 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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