Oral HabitsNCT04710511
Association Between Child's Psychological Resilience and Practicing Oral Habits
An observational study of Oral Habits, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of the present study is to determine the effect of psychological resilience on practicing oral habits among a group of 5- to 7-year-old children. Read more about this study
- Who is it for?
- Ages 5 to 7 years
- Conditions the study is for
- Oral Habits
- What is being tested?
- Child and Youth Resilience Measure - Revised (CYRM-R)
- Type of treatment
- Pill or oral medicine
- How many people
- 216 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jan 2021to 20 Jan 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
- Child
Study population: Medically free children aged from 5 years to 7 years
Who may be able to join
- Medically free children
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association Between Child's Psychological Resilience and Practicing Oral Habits: Cross Sectional Study
The aim of the present study is to determine the effect of psychological resilience on practicing oral habits among a group of 5- to 7-year-old children.
Read the detailed description
Psychological pressure has been thought to be a predisposing factor that might result in deleterious oral habits practicing. Shahraki et al. stated that increased stress levels are associated with oral habits as thumb sucking and nail biting. Leme et al. concluded that children and adolescents with DOH presented more symptoms of depression than their counterparts. Moreover, they were more likely to report symptoms of anxiety.
Ability to cope (or resilience) includes a person's sense of agency and their ability to think and behave, to make positive decisions, and to apply skills and knowledge to life challenges. The term resilience has come to mean an individual's ability to overcome adversity and continue his or her normal development.
The association between psychological resilience and practicing oral habits in children remains unclear, this study aims to reveal that association, if present.
- Conditions
- Oral Habits
- Being tested
- Child and Youth Resilience Measure - Revised (CYRM-R)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Child and Youth Resilience Measure - Revised (CYRM-R)Other
Also called Person Most Knowledgeable (PMK)
(CYRM-R): questionnaire , answered by the child (PMK): questionnaire, answered by the parent
| Study group | Role | What they receive |
|---|---|---|
| Control group | Medically free children aged from 5 years to 7 years and do not practice oral habits. Receives: Other: Child and Youth Resilience Measure - Revised (CYRM-R) | |
| Oral habit practicing group | Medically free children aged from 5 years to 7 years and practicing oral habits. Receives: Other: Child and Youth Resilience Measure - Revised (CYRM-R) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological resilience
Measured by: Child \& Youth Resilience Measure - Revised It Consists of 17 questions answered by the child, choices optiones scored as (No = 1 , sometimes = 2, Yes = 3) The upper limit of the score is 51 and the lower limit is 17 the higher the score the higher the psychological resilience that the child has.
Measured: Base line, subject will asked to fill the questionnaire for once
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start10 Jan 2021
- Primary completion13 Jan 2021
- Study completion20 Jan 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 216 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
- NCT04710511
- Sponsor's protocol ID
- M111
- Status last verified
- Jan 2021
- First submitted
- 12 Jan 2021
- Last updated
- 22 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Subject age, gender, and his score in (CYRM-R) \& (PMK) questionnaire.
Publications
Leme M, Barbosa T, Castelo P, Gaviao MB. Associations between psychological factors and the presence of deleterious oral habits in children and adolescents. J Clin Pediatr Dent. 2014 Summer;38(4):313-7. doi: 10.17796/jcpd.38.4.c48238322205466w.
PubMed 25571681Measure, Y. R. (2011). Child and Youth Resilience Measure.
Nicole, B., Velida, D.-S., & Michelle, R. (2018). Guidance on Measuring Children ' s Psychosocial Well - being. https://www.crs.org/sites/default/files/tools-research/meal4kids_well-being_guidance_aug_10_lo_res.pdf
Resilience Research Centre. (2018). Child and Youth Resilience Measure (CYRM-R) & Adult Resilience Measure (ARM-R) Manual 2.2. CYRM and ARM User Manual. http://www.resilienceresearch.org/
hahraki, N., Yassaei, S., & Moghadam, M. G. (2012). Abnormal oral habits: A review. Journal of Dentistry and Oral Hygiene, 4(May), 12-15. https://doi.org/10.5897/JDOH12.001
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Child's Psychological Resilience and Practicing Oral Habits: Cross Sectional Study
- ClinicalTrials.gov ID
- NCT04710511
- Acronym / sponsor ID
- M111
- Conditions
- Oral Habits
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Jan 2021 (actual)
- Primary completion
- 13 Jan 2021 (actual)
- Study completion
- 20 Jan 2021 (actual)
- First posted
- 14 Jan 2021 (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 psychological resilience on practicing oral habits among a group of 5- to 7-year-old children.
Detailed description
Psychological pressure has been thought to be a predisposing factor that might result in deleterious oral habits practicing. Shahraki et al. stated that increased stress levels are associated with oral habits as thumb sucking and nail biting. Leme et al. concluded that children and adolescents with DOH presented more symptoms of depression than their counterparts. Moreover, they were more likely to report symptoms of anxiety.
Ability to cope (or resilience) includes a person's sense of agency and their ability to think and behave, to make positive decisions, and to apply skills and knowledge to life challenges. The term resilience has come to mean an individual's ability to overcome adversity and continue his or her normal development.
The association between psychological resilience and practicing oral habits in children remains unclear, this study aims to reveal that association, if present.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | Other: Child and Youth Resilience Measure - Revised (CYRM-R)Medically free children aged from 5 years to 7 years and do not practice oral habits. |
| Oral habit practicing group | – | Other: Child and Youth Resilience Measure - Revised (CYRM-R)Medically free children aged from 5 years to 7 years and practicing oral habits. |
Who may qualify
- Ages
- 5 to 7 years
- Sex
- All
- Age groups
- Child
- Study population
- Medically free children aged from 5 years to 7 years
Key inclusion criteria (1 listed)
- Medically free children
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Child and Youth Resilience Measure - Revised (CYRM-R)Also: Person Most Knowledgeable (PMK)(CYRM-R): questionnaire , answered by the child (PMK): questionnaire, answered by the parent | Other | Control group, Oral habit practicing group |
Primary outcome
Psychological resilience
Time frame: Base line, subject will asked to fill the questionnaire for once
Measured by: Child \& Youth Resilience Measure - Revised It Consists of 17 questions answered by the child, choices optiones scored as (No = 1 , sometimes = 2, Yes = 3) The upper limit of the score is 51 and the lower limit is 17 the higher the score the higher the psychological resilience that the child has.
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 22 Jan 2021.
- Background: PubMed 25571681Leme M, Barbosa T, Castelo P, Gaviao MB. Associations between psychological factors and the presence of deleterious oral habits in children and adolescents. J Clin Pediatr Dent. 2014 Summer;38(4):313-7. doi: 10.17796/jcpd.38.4.c48238322205466w.
- BackgroundMeasure, Y. R. (2011). Child and Youth Resilience Measure.
- BackgroundNicole, B., Velida, D.-S., & Michelle, R. (2018). Guidance on Measuring Children ' s Psychosocial Well - being. https://www.crs.org/sites/default/files/tools-research/meal4kids_well-being_guidance_aug_10_lo_res.pdf
- BackgroundResilience Research Centre. (2018). Child and Youth Resilience Measure (CYRM-R) & Adult Resilience Measure (ARM-R) Manual 2.2. CYRM and ARM User Manual. http://www.resilienceresearch.org/
- Backgroundhahraki, N., Yassaei, S., & Moghadam, M. G. (2012). Abnormal oral habits: A review. Journal of Dentistry and Oral Hygiene, 4(May), 12-15. https://doi.org/10.5897/JDOH12.001
- Individual participant dataSharing planned: Undecided. Subject age, gender, and his score in (CYRM-R) \& (PMK) questionnaire.
Related trials for Oral Habits
Recruiting
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3D Printing, Oral Habit
Enrolling by invitationObservational study
Oral Hygiene and Dietary Habits in Physical Therapy and Pharmacy Students at Sinai University
Oral Hygiene, Nutrition Habits
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, 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 1 inclusion and 1 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 22 Jan 2021. 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?
Psychological resilience (time frame: Base line, subject will asked to fill the questionnaire 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 NCT04710511, 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 22 Jan 2021; AzTrials last refreshed its copy on 7 Nov 2026.