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Oral Hygiene Regimen in Patients on HCT

NCT02662374 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2016-01-25

No results posted yet for this study

Summary

Oral mucositis is one of the most common debilitating forms of mucositis that arise from high dose chemotherapy and radiotherapy. It is reported that almost 75% patients undergoing hematopoietic cell transplantation (HCT) develop oral mucositis at different levels of severity. The objective of this prospective study was to assess the efficacy of the addition of supersaturated calcium phosphate oral spray and the addition of an extra soft tooth brush to the basic OH in addition to the currently existing oral hygiene protocol regimen (0.2% Chlorhexidine Gluconate + 3% Sodium Bicarbonate+ Nystatin 100000 U/ml) in reducing the severity of oral mucositis among patients receiving chemotherapy for HCT.

60 patients receiving chemotherapy for HCT were randomly allocated to four groups of 15 patients each The oral mucositis was recorded according to WHO criteria and the progression of the oral mucositis was monitored from the day of admission (day

* 1\) to the day of discharge (day 28). The absolute neutrophil count, platelet counts and salivary flow rate of all patients was recorded.

Conditions

  • Oral Mucositis

Interventions

DRUG

.02% Chlorohexidine Gluconate

5ml of the drug in mouthwash form to be swished four times a day

DRUG

3% Sodium Bicarbonate

5ml of the drug in the form of a prepared solution to be swished four times a day

DRUG

Nystatin 10000U/ml

5ml of the drug in mouthwash form to be swished and swallowed four times a day

DEVICE

Extra Soft Toothbrush

To be moistened with 0.9% normal Saline and used twice daily to remove dental plaque

DRUG

Supersaturated Calcium Phosphate

5ml of the solution to be swished four times a day

Sponsors & Collaborators

  • King Faisal Specialist Hospital & Research Center

    collaborator OTHER

  • Riyadh Colleges of Dentistry and Pharmacy

    lead OTHER

Principal Investigators

  • abdullah R alshammery, PhD · RiyadhCPD

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2016-04-30
Completion
2016-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02662374 on ClinicalTrials.gov