The Effect of Oral Care Protocol on Prevention of Oral Mucositis in Pediatric Cancer Patients

NCT04586491 | Completed DMC

• 1 other identifier: Gülçin Özalp Gerçeker
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study conducted to determine the effects of two oral care protocols containing sodium bicarbonate or saline solution in the prevention of oral mucositis (OM), mucositis degree, and recovery time in children with cancer.

Conditions

Mucositis; Pediatric Cancer; Oral Cavity

Outcome Measures

Primary Outcomes (1)

• development of oral mucositis

  WHO Oral Mucositis Grading Scale: The WHO scale is dependent on both objective and subjective variables, and measures anatomical, symptomatic as well as functional components of oral mucositis. WHO Oral Mucositis Grading Scale

  until discharge from the hospital an average 1 week

Secondary Outcomes (2)

• severity of oral mucositis

  until discharge from the hospital an average 1 week

• recovery time of oral mucositis

  until discharge from the hospital an average 1 week

Study Arms (2)

Study group/ Oral care protocol with saline solution

EXPERIMENTAL

All patients took oral care protocol in the unit with saline solution

Combination Product: Oral care protocol

Control group/ Oral care protocol with sodium bicarbonate solution

EXPERIMENTAL

All patients took oral care protocol in the unit with sodium bicarbonate solution

Combination Product: Oral care protocol

Interventions

Oral care protocol COMBINATION_PRODUCT

Oral care protocol

Also known as: Daily evaluation of the inside of the mouth with the ChIMES, Gargle with solution, wiping the inside of the mouth with solution and sterile sponge, Brushing teeth with a soft toothbrush if platelet value was > 50000mm3., Training for the child and family in oral care.

Control group/ Oral care protocol with sodium bicarbonate solution; Study group/ Oral care protocol with saline solution

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• have cancer, aged 1-17 years, received chemotherapy for ≥3 days at inpatient clinics and whose families agreed to their participation in the study.

You may not qualify if:

• who have oral ulceration or mucositis, in terminal period, taking any antiviral or antifungal therapy for OM before enrollment in the study.

Sponsors & Collaborators

• Dokuz Eylul University: lead

Study Sites (1)

Gülçin Özalp Gerçeker

Izmir, 35100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Mucositis; Neoplasms

Interventions

CARE protocol; Mouthwashes; Solutions; Toothbrushing

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Biomedical and Dental Materials; Specialty Uses of Chemicals; Chemical Actions and Uses; Cosmetics; Manufactured Materials; Technology, Industry, and Agriculture; Pharmaceutical Preparations; Oral Hygiene; Preventive Dentistry; Dentistry

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dokuz Eylul University

Model Details: Prospective, randomised, parallel trial design

Study Record Dates

• First Submitted: October 12, 2020
• First Posted: October 14, 2020
• Study Start: October 7, 2019
• Primary Completion: February 10, 2020
• Study Completion: February 10, 2020
• Last Updated: October 19, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)