Breast CancerBREASTCANCERNCT06212908
Assessment of Periodontal Therapy and Biofilm Management in Breast Cancer
A study testing Basic Periodontal Therapy in people with Breast Cancer and Gingivitis, run by University of Sao Paulo.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Gingivitis, Periodontal
- What is being tested?
- Basic Periodontal Therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 18 Sep 2012to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
About this study
Official title: Integrating Periodontal Therapy and Biofilm Management Into Breast Cancer Patients' Care: Periodontal, Hematological and Salivary Parameters Assessment Before and During Chemotherapy
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.
Read the 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.
- Conditions
- Breast Cancer, Gingivitis, Periodontal
- Being tested
- Basic Periodontal Therapy
- Keywords
- Breast cancer, Gingivitis, Periodontal therapy
- Medical subject headings
- Breast Neoplasms, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Basic Periodontal TherapyOther
Also called Biofilm control
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.
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer | Other | 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. Receives: Other: Basic Periodontal Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periodontal conditions
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
Measured: before and after post treatment (baseline, 6 weeks, 12 and 24 weeks)
Secondary outcomes (1)
Salivary Flow
The salivary flow rate was expressed in milliliters per minute (mL/min). Periodontal parameters and salivary flow will be combined to assess oral health.
Measured: before and after post treatment (baseline, 6 weeks, 12 and 24 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start18 Sep 2012
- Primary completionDec 2015
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Daniela Bazan Palioto
- Responsible party
- Principal investigator, Kelly Rocio Vargas Villafuerte, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06212908
- Sponsor's protocol ID
- 03121212.6.3001.5440
- Acronym
- BREASTCANCER
- Status last verified
- Jan 2024
- First submitted
- 30 Dec 2023
- Last updated
- 19 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Periodontal Therapy and Biofilm Management Into Breast Cancer Patients' Care: Periodontal, Hematological and Salivary Parameters Assessment Before and During Chemotherapy
- ClinicalTrials.gov ID
- NCT06212908
- Acronym / sponsor ID
- BREASTCANCER / 03121212.6.3001.5440
- Conditions
- Breast Cancer, Gingivitis, Periodontal
- Keywords
- Breast cancer, Gingivitis, Periodontal therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Daniela Bazan Palioto
- Study start
- 18 Sep 2012 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 19 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast cancer | Other | Other: Basic Periodontal TherapyThe 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Basic Periodontal TherapyAlso: Biofilm controlAll 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 | Breast cancer |
Primary outcome
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
1 secondary outcome
Salivary Flow
Time frame: before and after post treatment (baseline, 6 weeks, 12 and 24 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Basic Periodontal Therapy in people with Breast Cancer and Gingivitis, run by University of Sao Paulo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Periodontal conditions (time frame: before and after post treatment (baseline, 6 weeks, 12 and 24 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2024.