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Completed

NCT Number: NCT04575792

Oral Habits Effect on Orofacial Dysfunction and Oral Health Related Quality of Life.

The aim of the present study is to determine the effect of oral habits on orofacial dysfunction and oral health related quality of life among a group of Egyptian children.

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Key information

Conditions

Oral Habits Oro-Facial Dysfunction

Age range

5 year–7 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Postgraduate clinics in Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Cairo University, Egyp

Cairo, Egypt

About this study

Child's OHRQoL is assessed in terms of four main categories: oral symptoms as pain and discomfort, functional limitations as reduced masticatory efficiency due to malocclusion, emotional limitations as reduced self-esteem and social limitations as being teased by other children.

Deleterious Oral Habit is believed to be associated with emotional disturbances and orofacial dysfunction which will certainly affect child's OHRQoL.

Sucking habits, mouth breathing habits and tongue thrusting habits are found to be the most deleterious habits, especially in the selected age group of (5-7) years. It was found that these three deleterious habits are the most practiced habits among Egyptian children aging from 6-9 years (19.6%).

Up to the investigator's knowledge, there are very scanty studies investigating the effect of orofacial dysfunction on OHRQoL in children, only one of them was conducted on children practicing oral habits, but none of them was conducted on Egyptian children.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Cooperative Egyptian children aging from (5 - 7) years.
  • Medically free children.
  • Children whose families accept to participate in this study.

Exclusion criteria

  • Children with untreated caries.
  • Children with previous untreated dental trauma.
  • Children with previous orthodontic treatment
  • Children with upper respiratory disease
  • Children having one or more of the following conditions: MIH, amelogenesis imperfecta, dentinogenesis imperfecta, hypodontia, dental fluorosis.

Treatment and study plan

Practicing oral habits

Behavioral

children who practice one or more of the specified oral habits ( mouth breathing, object sucking, or tongue thrusting) are considered exposed.

Primary outcomes

  1. Orofacial dysfunction

    Time frame: Baseline: Child will be examined for once.

    Measured by Nordic Orofacial Test Screen. Measuring Unit: Scores (from 0 to 12) consists of two main parts: First part is NOT-S Interview and the second part is NOT-S Examination. Each part contains six domains as following (Appendix 2):

    • NOT-S Interview: I. Sensory function. II. Breathing. III. Habits. IV. Chewing and swallowing. V. Drooling. VI. Dry mouth.
    • NOT-S Examination:
    • Face at rest.
    • Nose breathing.
    • Facial expression.
    • Masticatory muscle and jaw function.
    • Oral motor function.
    • Speech

Secondary outcomes

  1. Oral Health Related Quality of Life

    Time frame: Baseline: the questionnaire will be filled by child's caregiver for once.

    Measured by: Parental Caregiver Perciption Questionnaire and Family Impact Scale. Measuring Unit: Scores, For Parental-Caregiver Perception Questionnaire: from 0 to 32 For Family Impact scale : from 0 to 32.

    • Parental- Caregiver Perception Questionnaire consists of 4 sections:
    • Oral symptoms domain (2 items).
    • Functional limitation domain (2 items).
    • Emotional well-being domain (2 items).
    • Social well-being domain (2 items).
    • Family Impact Scale consists of 3 sections:
    • Parental emotions domain (2 items).
    • Parental / family activity domain (4 items).
    • Family conflict domain (2 items).

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Effect of Oral Habits on Orofacial Dysfunction and Oral Health Related Quality of Life Among a Group of Egyptian Children: Cohort Study

Acronym: OHRQoL

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Oct 5, 2020
Registry last updated
Mar 9, 2022

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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