Oral Hygiene Management of Hematologic Patients Undergoing Auto-transplantation

NCT06755333 | Completed

• 1 other identifier: 150782024
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Hematopoietic Stem Cell Transplantation

Keywords

Hematopoietic Stem Cell Transplantation; Dental Prophylaxis; Oral Hygiene; Motivation

Outcome Measures

Primary Outcomes (5)

• 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)

Interventions

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• \- denial of the consent to participate in the study

Sponsors & Collaborators

• University of Pisa: lead

Study Sites (1)

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

Pisa, Italy

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher at the Department of Surgical, Medical and Molecular Pathology and Critical Care Medicine of the University of Pisa, Principal Investigator

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: January 1, 2025
• Study Start: January 9, 2023
• Primary Completion: September 29, 2023
• Study Completion: May 31, 2024
• Last Updated: January 1, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)