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Completed

NCT Number: NCT06755333

Oral Hygiene Management of Hematologic Patients Undergoing Auto-transplantation

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).

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Key information

Conditions

Hematopoietic Stem Cell Transplantation

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Surgical, Medical and Molecular Pathology and Critical Care Medicine, University Hospital of Pisa

Pisa, Italy

About this study

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).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • male or female patients
  • aged 18-75 years
  • patients scheduled for HSCT
  • acceptance of study participation
  • compliance to follow-up

Exclusion criteria

  • denial of the consent to participate in the study

Treatment and study plan

Oral hygiene motivation

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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

  5. 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).

Sponsors and collaborators

Lead sponsor

University of Pisa

Other

Registry information

Official study title

Oral Hygiene Management of Hematologic Patients Undergoing Auto-transplantation: Observational Study

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Jan 1, 2025
Registry last updated
Jan 1, 2025

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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