Assessment of Periodontal Therapy and Biofilm Management in Breast Cancer

NCT ID: NCT06212908

Last Updated: 2024-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-18

Study Completion Date

2016-12-31

Brief Summary

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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

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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.

Conditions

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Breast Cancer Gingivitis Periodontal

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Basic Periodontal Therapy

Intervention Type 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.

Interventions

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Basic Periodontal Therapy

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.

Intervention Type OTHER

Other Intervention Names

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Biofilm control

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Daniela Bazan Palioto

UNKNOWN

Sponsor Role collaborator

University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Kelly Rocio Vargas Villafuerte

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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03121212.6.3001.5440

Identifier Type: -

Identifier Source: org_study_id

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