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Oral Hygiene Management of Hematologic Patients Undergoing Auto-transplantation

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06755333
Enrollment
35
Registered
2025-01-01
Start date
2023-01-09
Completion date
2024-05-31
Last updated
2025-01-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematopoietic Stem Cell Transplantation

Keywords

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

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).

Interventions

BEHAVIORALOral hygiene motivation

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.

Sponsors

University of Pisa
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
PPDmeasured 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.
FMBSmeasured 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
FMPSmeasured 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
CImeasured 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 MUCOSITISmeasured 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).

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026