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

Sponsor
Cairo University (Other)
Overall Status
Completed
CT.gov ID
NCT04575792
Collaborator
(none)
60
1
3
20.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Practicing oral habits

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 Design

Study Type:
Observational
Actual Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Effect of Oral Habits on Orofacial Dysfunction and Oral Health Related Quality of Life Among a Group of Egyptian Children: Cohort Study
Actual Study Start Date :
Jan 1, 2021
Actual Primary Completion Date :
Apr 1, 2021
Actual Study Completion Date :
Apr 1, 2021

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Orofacial dysfunction [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 Outcome Measures

  1. Oral Health Related Quality of Life [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Years to 7 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Postgraduate clinics in Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Cairo University, Egyp Cairo Egypt

Sponsors and Collaborators

  • Cairo University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Mennat Allah Ashraf Abd Elsabour Abd Elkareem, Principal Investigator, Cairo University
ClinicalTrials.gov Identifier:
NCT04575792
Other Study ID Numbers:
  • 1111
First Posted:
Oct 5, 2020
Last Update Posted:
Mar 9, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Mar 9, 2022