Hematopoietic Stem Cell TransplantationNCT06755333
Oral Hygiene Management of Hematologic Patients Undergoing Auto-transplantation
An observational study of Hematopoietic Stem Cell Transplantation, run by University of Pisa at 1 site in Italy.
Trial summary
This study assessed the effectiveness of a preventive protocol that included oral hygiene measures, patient education, and motivational strategies in individuals eligible for hematopoietic stem cell transplantation (HSCT). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hematopoietic Stem Cell Transplantation
- What is being tested?
- Oral hygiene motivation
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- How many people
- 35 participants
- Where
- 1 siteItaly
- Study dates
- 9 Jan 2023to 31 May 2024
- Phase
- Observational
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients undergoing autologous hematopoietic stem cell transplantation (HSCT) for hematologic diseases. The study included patients treated at the Hematology Unit of Pisa University Hospital. Participants were selected based on their eligibility for HSCT and their consent to participate in the study
Who may be able to join
- male or female patients
- aged 18-75 years
- patients scheduled for HSCT
- acceptance of study participation
- compliance to follow-up
Who cannot join
- denial of the consent to participate in the study
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Surgical, Medical and Molecular Pathology and Critical Care Medicine, University Hospital of Pisa
Pisa
About this study
Official title: Oral Hygiene Management of Hematologic Patients Undergoing Auto-transplantation: Observational Study
This study assessed the effectiveness of a preventive protocol that included oral hygiene measures, patient education, and motivational strategies in individuals eligible for hematopoietic stem cell transplantation (HSCT).
Read the detailed description
At baseline (T0), the patient underwent a professional oral hygiene session prior to initiating chemotherapy, as part of the routine pre-transplant protocol. During this session, periodontal charting was completed, and patients were provided with oral hygiene instructions.
Following admission, patients received pre-transplant conditioning chemotherapy. Once engraftment of the transplant was confirmed by the Hematology Unit (9 days after engraftment), clinical parameters were reassessed (T1).
- Conditions
- Hematopoietic Stem Cell Transplantation
- Being tested
- Oral hygiene motivation
- Keywords
- Hematopoietic Stem Cell Transplantation, Dental Prophylaxis, Oral Hygiene, Motivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral hygiene motivationBehavioural
the patient underwent a professional oral hygiene session before starting chemotherapy, as part of the routine pre-transplant procedure. Patients then received oral hygiene instructions.
What is being measured
The primary outcome is the main question the study is designed to answer.
PPD
probing pocket depth (PPD) was measured as the distance from the free gingival margin to the bottom of the pocket by inserting a periodontal probe parallel to the longitudinal axis of the tooth using a periodontal probe (UNC 15, Hu-Friedy, Chicago, IL, USA) and a calibrated pressure of 0.3 N. All measurements were rounded to the nearest millimetre.
Measured: measured at enrolment (T0) and 9 days after engraftment (T1)
FMBS
Full Mouth Bleeding Score (FMBS) was measured dichotomously after periodontal probing. The mean bleeding score was indicated as percentage of sites detected positive for bleeding on the total number of sites
Measured: measured at enrolment (T0) and 9 days after engraftment (T1)
FMPS
Full Mouth Plaque Score (FMPS) was assessed the presence or absence of plaque on each tooth surface. The presence of plaque was evaluated as 1, while the absence as 0, on 6 sites per tooth (distobuccal, buccal, mesiobuccal, distolingual, lingual, mesiolingual). Mean plaque score was indicated as percentage of sites found positive for the presence of plaque on the total number of sites
Measured: measured at enrolment (T0) and 9 days after engraftment (T1)
CI
Calculus Index was measured using a probe and considering supragingival and subgingival calculus separately, with score 0 assigned in the absence of calculus and score 3 assigned to supragingival calculus exceeding two-thirds of the crown and/or continuous bands of subgingival calculus
Measured: measured at enrolment (T0) and 9 days after engraftment (T1)
PRESENCE OF MUCOSITIS
Presence of mucositis was evaluated as the presence of mucosal erythema or ulceration for 8 oral sites and assigning a score from 0 (normal oral mucosa) to 5 (>3 sites of ulceration).
Measured: measured 9 days after engraftment (T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study start9 Jan 2023
- Primary completion29 Sep 2023
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic Stem Cell TransplantationStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pisa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rossana Izzetti, University of Pisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06755333
- Sponsor's protocol ID
- 150782024
- Status last verified
- Dec 2024
- First submitted
- 18 Dec 2024
- Last updated
- 1 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Hygiene Management of Hematologic Patients Undergoing Auto-transplantation: Observational Study
- ClinicalTrials.gov ID
- NCT06755333
- Acronym / sponsor ID
- 150782024
- Conditions
- Hematopoietic Stem Cell Transplantation
- Keywords
- Hematopoietic Stem Cell Transplantation, Dental Prophylaxis, Oral Hygiene, Motivation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of PisaUniversity, hospital or other
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- 29 Sep 2023 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 1 Jan 2025 (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.
This study assessed the effectiveness of a preventive protocol that included oral hygiene measures, patient education, and motivational strategies in individuals eligible for hematopoietic stem cell transplantation (HSCT).
Detailed description
At baseline (T0), the patient underwent a professional oral hygiene session prior to initiating chemotherapy, as part of the routine pre-transplant protocol. During this session, periodontal charting was completed, and patients were provided with oral hygiene instructions.
Following admission, patients received pre-transplant conditioning chemotherapy. Once engraftment of the transplant was confirmed by the Hematology Unit (9 days after engraftment), clinical parameters were reassessed (T1).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing autologous hematopoietic stem cell transplantation (HSCT) for hematologic diseases. The study included patients treated at the Hematology Unit of Pisa University Hospital. Participants were selected based on their eligibility for HSCT and their consent to participate in the study
Key inclusion criteria (5 listed)
- male or female patients
- aged 18-75 years
- patients scheduled for HSCT
- acceptance of study participation
- compliance to follow-up
Key exclusion criteria (1 listed)
- denial of the consent to participate in the study
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 |
|---|---|---|
| Oral hygiene motivationthe patient underwent a professional oral hygiene session before starting chemotherapy, as part of the routine pre-transplant procedure. Patients then received oral hygiene instructions. | Behavioural | – |
Primary outcome
PPD
Time frame: measured at enrolment (T0) and 9 days after engraftment (T1)
probing pocket depth (PPD) was measured as the distance from the free gingival margin to the bottom of the pocket by inserting a periodontal probe parallel to the longitudinal axis of the tooth using a periodontal probe (UNC 15, Hu-Friedy, Chicago, IL, USA) and a calibrated pressure of 0.3 N. All measurements were rounded to the nearest millimetre.
FMBS
Time frame: measured at enrolment (T0) and 9 days after engraftment (T1)
Full Mouth Bleeding Score (FMBS) was measured dichotomously after periodontal probing. The mean bleeding score was indicated as percentage of sites detected positive for bleeding on the total number of sites
FMPS
Time frame: measured at enrolment (T0) and 9 days after engraftment (T1)
Full Mouth Plaque Score (FMPS) was assessed the presence or absence of plaque on each tooth surface. The presence of plaque was evaluated as 1, while the absence as 0, on 6 sites per tooth (distobuccal, buccal, mesiobuccal, distolingual, lingual, mesiolingual). Mean plaque score was indicated as percentage of sites found positive for the presence of plaque on the total number of sites
CI
Time frame: measured at enrolment (T0) and 9 days after engraftment (T1)
Calculus Index was measured using a probe and considering supragingival and subgingival calculus separately, with score 0 assigned in the absence of calculus and score 3 assigned to supragingival calculus exceeding two-thirds of the crown and/or continuous bands of subgingival calculus
PRESENCE OF MUCOSITIS
Time frame: measured 9 days after engraftment (T1)
Presence of mucositis was evaluated as the presence of mucosal erythema or ulceration for 8 oral sites and assigning a score from 0 (normal oral mucosa) to 5 (>3 sites of ulceration).
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 1 Jan 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematopoietic Stem Cell Transplantation, run by University of Pisa at 1 site in Italy.
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 5 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 1 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
PPD (time frame: measured at enrolment (T0) and 9 days after engraftment (T1)). The study lists 5 primary outcomes in all. 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 1 Jan 2025.