Effect of Oral Health Educational Program on the Oral Health Related Quality of Life in a Group of Children with Chronic Kidney Disease (CKD)

March 14, 2025 updated by: Hebaallah Samy Gamil Mohamed, Cairo University

Effect of Oral Health Educational Program on the Oral Health-Related Quality of Life in a Group of Children with Chronic Kidney Disease: a Before and After Pilot Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Giza, Egypt
        • Cairo Unversity

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Children with CKD
Behavioral: Oral Health Educational Program
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oral health related quality of life
Time Frame: 3 months
it will be assessed using a questionnaire and the measurement unit is percentage
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Developmental enamel defect.
Time Frame: 3 months

it will be assessed using the DDE (Developmental Defects of Enamel) index and the measurement unit is Mean SD.

The DDE index categorizes defects into three main types:

Opacities: Changes in enamel translucency, which can be diffuse or demarcated. Hypoplasia: A quantitative defect where enamel is thinner or missing in certain areas.

Discoloration: Changes in enamel color due to structural abnormalities. higher scores means worse outcome.
3 months
Caries experience.
Time Frame: 3 months

it will be assessed using the def(decayed, extracted,filled) index and the measurement unit is Mean SD.

The def score is the sum of these values, providing an indication of oral health in children before their permanent teeth emerge.

higher scores means worse outcome.
3 months
Caries experience
Time Frame: 3 months

it will be assessed using the DMF (Decayed, Missing, Filled) index and the measurement unit is mean SD.

The DMF score is the sum of these values, indicating the overall caries experience in an individual or population. Unlike the def index, which applies to primary teeth, the DMF index is used for permanent teeth.

higher scores means worse outcome.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 15, 2025

Primary Completion (Estimated)

June 15, 2025

Study Completion (Estimated)

September 15, 2025

Study Registration Dates

First Submitted

March 10, 2025

First Submitted That Met QC Criteria

March 14, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 14, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Educational program on CKD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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