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NCT Number: NCT06879223

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

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.

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Key information

Conditions

Chronic Kidney Disease(CKD) Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

8 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo Unversity

Giza, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

oral health educational program

Behavioral

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.

Primary outcomes

  1. Oral health related quality of life

    Time frame: 3 months

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

Secondary outcomes

  1. 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.

  2. 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. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

HebaAllah Samy Dentist

CONTACT

[email protected]

+20 1125450657

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Acronym: CKD

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 17, 2025
Registry last updated
Mar 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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