Oral Hygiene Management of Hematologic Patients Undergoing Auto-transplantation

Completed

• Conditions: Hematopoietic Stem Cell Transplantation

• Registration Number: NCT06755333
• Lead Sponsor: University of Pisa

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).

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 Timeline

• Study Start: 2023-01-09
• Primary Completion: 2023-09-29
• Study Completion: 2024-05-31
• Status Verified: 2024-12
• Study First Submitted: 2024-12-18
• Study First Submitted QC: 2024-12-24
• Last Update Submitted: 2024-12-24
• Study First Posted: 2025-01-01
• Last Update Posted: 2025-01-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

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

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Exclusion Criteria

• denial of the consent to participate in the study

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PPD	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	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	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	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	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).

Trial Locations

Locations (1)

Department of Surgical, Medical and Molecular Pathology and Critical Care Medicine, University Hospital of Pisa; 🇮🇹 Pisa, Italy