Oral HabitsOHRQoLNCT04575792
Oral Habits Effect on Orofacial Dysfunction and Oral Health Related Quality of Life.
An observational study of Oral Habits and Oro-Facial Dysfunction, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Habits, Oro-Facial Dysfunction
- What is being tested?
- Practicing oral habits
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2021to 1 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Healthy Egyptian children aging from 5 to 7 years old.
Who may be able to join
- Cooperative Egyptian children aging from (5 - 7) years.
- Medically free children.
- Children whose families accept to participate in this study.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Postgraduate clinics in Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Cairo University, Egyp
Cairo
About this study
Official title: 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.
Read the 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.
- Conditions
- Oral Habits, Oro-Facial Dysfunction
- Being tested
- Practicing oral habits
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Practicing oral habitsBehavioural
children who practice one or more of the specified oral habits ( mouth breathing, object sucking, or tongue thrusting) are considered exposed.
| Study group | Role | What they receive |
|---|---|---|
| C group | C group: control group, children who do not practice oral habits. | |
| E group | E group: exposed group, children who practicing oral habits. Receives: Behavioral: Practicing oral habits |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- Face at rest.
- Nose breathing.
- Facial expression.
- Masticatory muscle and jaw function.
- Oral motor function.
- Speech
Measured: Baseline: Child will be examined for once.
Secondary outcomes (1)
Oral Health Related Quality of Life
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).
Measured: Baseline: the questionnaire will be filled by child's caregiver for once.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start1 Jan 2021
- Primary completion1 Apr 2021
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Oral HabitsStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mennat Allah Ashraf Abd Elsabour Abd Elkareem, Cairo University
- Investigators
- Mennat Allah A.Elkareem, B.D.S, Principal investigator, Fuculty of Dentistry, Ahram Canadian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04575792
- Sponsor's protocol ID
- 1111
- Acronym
- OHRQoL
- Status last verified
- Mar 2022
- First submitted
- 26 Sep 2020
- Last updated
- 9 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 23739786Al-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.
PubMed 26792967Kumar 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.
PubMed 26932786Bakke 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.
PubMed 17695052Abd-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.
PubMed 36001236
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oral Habits on Orofacial Dysfunction and Oral Health Related Quality of Life Among a Group of Egyptian Children: Cohort Study
- ClinicalTrials.gov ID
- NCT04575792
- Acronym / sponsor ID
- OHRQoL / 1111
- Conditions
- Oral Habits, Oro-Facial Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 5 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| C group | – | –C group: control group, children who do not practice oral habits. |
| E group | – | Behavioral: Practicing oral habitsE group: exposed group, children who practicing oral habits. |
Who may qualify
- Ages
- 5 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Healthy Egyptian children aging from 5 to 7 years old.
Key inclusion criteria (3 listed)
- Cooperative Egyptian children aging from (5 - 7) years.
- Medically free children.
- Children whose families accept to participate in this study.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Practicing oral habitschildren who practice one or more of the specified oral habits ( mouth breathing, object sucking, or tongue thrusting) are considered exposed. | Behavioural | E group |
Primary outcome
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
1 secondary outcome
Oral Health Related Quality of Life
Time frame: Baseline: the questionnaire will be filled by child's caregiver for once.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
- Background: PubMed 23739786Leme 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.
- Background: PubMed 26792967Al-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.
- Background: PubMed 26932786Kumar 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.
- Background: PubMed 17695052Bakke 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.
- Derived from this study: PubMed 36001236Abd-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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mennat Allah A.Elkareem, B.D.S principal investigator
Fuculty of Dentistry, Ahram Canadian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Habits and Oro-Facial Dysfunction, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Orofacial dysfunction (time frame: Baseline: Child will be examined for once.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04575792, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2022.