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

March 8, 2022 updated by: Mennat Allah Ashraf Abd Elsabour Abd Elkareem, Cairo University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

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

Study Locations

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

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

5 years to 7 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Healthy Egyptian children aging from 5 to 7 years old.

Description

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.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
C group
C group: control group, children who do not practice oral habits.
E group
E group: exposed group, children who practicing oral habits.
Behavioral: Practicing oral habits
children who practice one or more of the specified oral habits ( mouth breathing, object sucking, or tongue thrusting) are considered exposed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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:

  1. Face at rest.
  2. Nose breathing.
  3. Facial expression.
  4. Masticatory muscle and jaw function.
  5. Oral motor function.
  6. Speech
Baseline: Child will be examined for once.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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:

    1. Oral symptoms domain (2 items).
    2. Functional limitation domain (2 items).
    3. Emotional well-being domain (2 items).
    4. Social well-being domain (2 items).

  • Family Impact Scale consists of 3 sections:

    1. Parental emotions domain (2 items).
    2. Parental / family activity domain (4 items).
    3. Family conflict domain (2 items).
Baseline: the questionnaire will be filled by child's caregiver for once.

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Principal Investigator: Mennat Allah A.Elkareem, B.D.S, Fuculty of Dentistry, Ahram Canadian University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (ACTUAL)

January 1, 2021

Primary Completion (ACTUAL)

April 1, 2021

Study Completion (ACTUAL)

April 1, 2021

Study Registration Dates

First Submitted

September 26, 2020

First Submitted That Met QC Criteria

October 1, 2020

First Posted (ACTUAL)

October 5, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 9, 2022

Last Update Submitted That Met QC Criteria

March 8, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 1111 (Prima Psychiatry internal research fund)

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

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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