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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2021

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 26, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 5, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 9, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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