Integrating Periodontal Therapy and Biofilm Management Into Breast Cancer Patients' Care: Periodontal, Hematological and Salivary Parameters Assessment Before and During Chemotherapy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Sao Paulo
- Enrollment
- 40
- Primary Endpoint
- Periodontal conditions
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Sequential
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Arms & Interventions
Breast cancer
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.
Intervention: Basic Periodontal Therapy (Other)
Outcomes
Primary Outcomes
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
- Salivary Flow(before and after post treatment (baseline, 6 weeks, 12 and 24 weeks))
Investigators
Kelly Rocio Vargas Villafuerte
Principal Investigator
University of Sao Paulo