NCT04575792

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 5, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

March 9, 2022

Status Verified

March 1, 2022

Enrollment Period

3 months

First QC Date

September 26, 2020

Last Update Submit

March 8, 2022

Conditions

Oral HabitsOro-Facial Dysfunction

Outcome Measures

Primary Outcomes (1)

  • Orofacial dysfunction

    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 Outcomes (1)

  • Oral Health Related Quality of Life

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

Study Arms (2)

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

Interventions

Practicing oral habitsBEHAVIORAL

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

E group

Eligibility Criteria

Age5 Years - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Healthy Egyptian children aging from 5 to 7 years old.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Cairo, Egypt

Location

Related Publications (5)

  • Leme MS, Souza Barbosa Td, Gaviao MB. Relationship among oral habits, orofacial function and oral health-related quality of life in children. Braz Oral Res. 2013 May-Jun;27(3):272-8. doi: 10.1590/S1806-83242013000300006.

    PMID: 23739786BACKGROUND

  • Al-Riyami IA, Thomson WM, Al-Harthi LS. Testing the Arabic short form versions of the Parental-Caregivers Perceptions Questionnaire and the Family Impact Scale in Oman. Saudi Dent J. 2016 Jan;28(1):31-5. doi: 10.1016/j.sdentj.2015.08.001. Epub 2015 Nov 22.

    PMID: 26792967BACKGROUND

  • Kumar S, Kroon J, Lalloo R, Johnson NW. Validity and reliability of short forms of parental-caregiver perception and family impact scale in a Telugu speaking population of India. Health Qual Life Outcomes. 2016 Mar 1;14:34. doi: 10.1186/s12955-016-0433-7.

    PMID: 26932786BACKGROUND

  • Bakke M, Bergendal B, McAllister A, Sjogreen L, Asten P. Development and evaluation of a comprehensive screening for orofacial dysfunction. Swed Dent J. 2007;31(2):75-84.

    PMID: 17695052BACKGROUND

  • Abd-Elsabour MAAA, Hanafy RMH, Omar OM. Effect of self-perceived oral habits on orofacial dysfunction and oral health-related quality of life among a group of Egyptian children: a cohort study. Eur Arch Paediatr Dent. 2022 Dec;23(6):935-944. doi: 10.1007/s40368-022-00740-8. Epub 2022 Aug 24.

    PMID: 36001236DERIVED

Study Officials

  • Mennat Allah A.Elkareem, B.D.S

    Fuculty of Dentistry, Ahram Canadian University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 26, 2020

First Posted

October 5, 2020

Study Start

January 1, 2021

Primary Completion

April 1, 2021

Study Completion

April 1, 2021

Last Updated

March 9, 2022

Record last verified: 2022-03

Locations

EG(1)