NCT06879223

Brief Summary

Children with CKD are at higher risk for poor oral health28 due to factors such as compromised immunity, medication side effects, and dietary restrictions. Poor oral health can lead to pain, infection, and difficulties in eating and speaking, which in turn negatively affects their quality of life. This study is designed to address this gap by exploring how an oral health educational program could improve the oral health-related quality of life (OHRQoL) in this group.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 17, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

June 15, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2025

Completed
Last Updated

March 17, 2025

Status Verified

March 1, 2025

Enrollment Period

Same day

First QC Date

March 10, 2025

Last Update Submit

March 14, 2025

Conditions

Chronic Kidney Disease(CKD)

Keywords

CKD OHRQLOHEP

Outcome Measures

Primary Outcomes (1)

  • Oral health related quality of life

    it will be assessed using a questionnaire and the measurement unit is percentage

    3 months

Secondary Outcomes (3)

  • Developmental enamel defect.

    3 months

  • Caries experience.

    3 months

  • Caries experience

    3 months

Study Arms (1)

Children with CKD

EXPERIMENTAL
Behavioral: Oral Health Educational Program

Interventions

Oral Health Educational ProgramBEHAVIORAL

Providing the children with an educational program through a data show presentation when and how to brush their teeth, causes of dental caries and how to prevent its occurrence. A flyer will be distributed including simple language about preventive measure of dental caries and schedule of teeth brushing to ensure retention of information.

Children with CKD

Eligibility Criteria

Age8 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age 8-10 years old.
  • Diagnosed with Chronic Kidney Disease

You may not qualify if:

  • Children with other systemic diseases.
  • Parents that refuse the participation of their children.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo Unversity

Giza, Egypt

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

HebaAllah Samy Dentist

CONTACT

+20 1125450657hebaallah.samy@dentistry.cu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dentist

Study Record Dates

First Submitted

March 10, 2025

First Posted

March 17, 2025

Study Start

June 15, 2025

Primary Completion

June 15, 2025

Study Completion

September 15, 2025

Last Updated

March 17, 2025

Record last verified: 2025-03

Locations

EG(1)