NCT05224882

Brief Summary

The prevention of oral illnesses in children and adolescents undergoing oncological treatment is critical, because oral lesions caused by this therapy significantly exacerbate the clinical condition and increase the risk of infection, as well as making it harder to perform required dental procedures when needed . "The key to success in maintaining a healthy oral cavity during therapy is patient compliance. The child and the parents should be educated regarding the possible acute side effects." Pediatric cancer patients may have a lower quality of life if they have poor dental health. Preventing and treating pre-existing oral illnesses is critical to reduce problems in these people. It is critical to raise awareness of the benefits of proper oral health so that this understanding becomes a positive attitude, reducing the discomfort of these children. The American Academy of Pediatric Dentistry (AAPD) recommends pediatric oncology/hematology that Pediatric dentists must be involved in the treatment process from the moment cancer is diagnosed. This should be carried out by having a preventive and dental care plan developed based on the patient's needs before any cancer treatment is initiated. The aim of the study is primarily to report oral complications and manifestations during chemotherapy treatment in pediatric cancer patients and raise the awareness of their parents on these manifestations thus proper interventions can be carried out to prevent more serious problems.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
441

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2023

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 4, 2022

Completed
1.5 years until next milestone

Study Start

First participant enrolled

August 12, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 27, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2024

Completed
Last Updated

November 29, 2022

Status Verified

November 1, 2022

Enrollment Period

4 months

First QC Date

January 25, 2022

Last Update Submit

November 26, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • The assessment of the prevalence of oral adverse events induced by chemotherapy in pediatric cancer patients .

    Patients will be examined for oral manifestations at the first visit together with intra oral photos will be taken for the patients included in the study. Voice ,swallow ,tongue, saliva, mucous membrane\*\*, gingiva ,teeth will be measured by Oral Assessment Guide by the principal investigator . \*\*If oral mucositis is present it will be staged according to the World Health Organization Scale (WHO Oral Toxicity Scale) by the principal investigator.

    Baseline

Secondary Outcomes (1)

  • Assessment of dental awareness among parents of pediatric cancer patients .

    Baseline

Eligibility Criteria

Age1 Year - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

The study will be carried out at the pediatric clinic of the National Cancer Institute ,Egypt. Pediatric patients and their parents at the pediatric clinic will be screened until the target population is achieved. The pediatric patients will be subjected to thorough examination. Once the patient and the parent are potentially eligible for this study, the principal investigator will explain the study and ascertain the patient's and the parents' interest. The legal guardian provides written informed consent for participation in the study.

You may qualify if:

  • Children between the age of 1 -14years.
  • Children receiving chemotherapy for hematological cancer or solid tumors.
  • Parents who are able to understand the aim of the study and willing to participate in the study.

You may not qualify if:

  • Children previously received radiotherapy on head and neck region.
  • Children suffering from oral cancer.
  • Children presented with other oral disorders such as leukoplakia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stomatitis

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Study Officials

  • Sherif Bahgat, Professor

    Professor of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Cairo University.

    STUDY CHAIR

Central Study Contacts

Amira M Al-Naggar, B.D.S

CONTACT

Yasmin Yousry, PHD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 25, 2022

First Posted

February 4, 2022

Study Start

August 12, 2023

Primary Completion

November 27, 2023

Study Completion

January 25, 2024

Last Updated

November 29, 2022

Record last verified: 2022-11