Oral Hygiene Management of Hematologic Patients Undergoing Auto-transplantation

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).

Study Overview

• Status: Completed
• Conditions: Hematopoietic Stem Cell Transplantation
• Intervention / Treatment: Behavioral: Oral hygiene motivation

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 Type: Observational
• Enrollment (Actual): 35

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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 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 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 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 9 days after engraftment (T1)

Collaborators and Investigators

• Sponsor: University of Pisa

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2023
• Primary Completion (Actual): September 29, 2023
• Study Completion (Actual): May 31, 2024

Study Registration Dates

• First Submitted: December 18, 2024
• First Submitted That Met QC Criteria: December 24, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 24, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Motivation; Hematopoietic Stem Cell Transplantation; Oral Hygiene; Dental Prophylaxis
• Other Study ID Numbers: 150782024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No