Oral HabitNCT02944422
The Prevalence of Oral Habits in a Group of Primary School Children in Cairo Governorate
An observational study of Oral Habit, run by Cairo University.
Trial summary
This study is designed to determine the prevalence of oral habits among primary Egyptian school children in Cairo Governorate, Egypt. Read more about this study
- Who is it for?
- Ages 7 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Habit
- How many people
- 624 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Feb 2017
- 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 7 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Primary school Egyptian children.
Who may be able to join
- Cooperative children of 7-10 years old
- Children with no intellectual problems
Who cannot join
- Children with orthodontic appliances
- Medically compromised children
- Children of families who refuse to participate in the study
Trial locations and contacts
No sites are listed yet.
Randa Youssef, Lecturer contact
About this study
Official title: The Prevalence of Oral Habits in a Group of Primary School Children in Cairo Governorate: A Cross-Sectional Study
This study is designed to determine the prevalence of oral habits among primary Egyptian school children in Cairo Governorate, Egypt.
Read the detailed description
This aim of this study is to determine the prevalence of oral habits among primary Egyptian school children in Cairo Governorate, Egypt.
PICO:
P: Egyptian primary school children of 7 - 10 years old
O: Prevalence of oral habits
Primary Outcome: Prevalence of Oral Habit; Device of Measurement: Questionnaire; Unit of Measurement: Binary.
- Conditions
- Oral Habit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Males | Primary school Egyptian boys from 7-10 years. | |
| Females | Primary school Egyptian girls from 7-10 years. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Oral Habit
Measurement that will be used: Questionnaire
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Oral HabitStudies 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
- Time perspective
- Cross-sectional
- Enrolment
- 624 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yomna Hassan Saad, Cairo University
- Investigators
- Mahmoud Hamdy, Professor, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02944422
- Sponsor's protocol ID
- CEBC-CU-2016-10-142
- Status last verified
- Oct 2016
- First submitted
- 24 Oct 2016
- Last updated
- 25 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Shetty SR, Munshi AK. Oral habits in children--a prevalence study. J Indian Soc Pedod Prev Dent. 1998 Jun;16(2):61-6.
PubMed 11813757Quashie-Williams R, daCosta OO, Isiekwe MC. Oral habits, prevalence and effects on occlusion of 4-15 year old school children in Lagos, Nigeria. Niger Postgrad Med J. 2010 Jun;17(2):113-7.
PubMed 20539325Onyeaso CO. Oral habits among 7-10 year-old school children in Ibadan, Nigeria. East Afr Med J. 2004 Jan;81(1):16-21. doi: 10.4314/eamj.v81i1.8789.
PubMed 15080510Lagana G, Masucci C, Fabi F, Bollero P, Cozza P. Prevalence of malocclusions, oral habits and orthodontic treatment need in a 7- to 15-year-old schoolchildren population in Tirana. Prog Orthod. 2013 Jun 14;14:12. doi: 10.1186/2196-1042-14-12.
PubMed 24326142Kharbanda OP, Sidhu SS, Sundaram K, Shukla DK. Oral habits in school going children of Delhi: a prevalence study. J Indian Soc Pedod Prev Dent. 2003 Sep;21(3):120-4.
PubMed 14703220M Hegde A, M Xavier A. Childhood Habits: Ignorance is not Bliss- A Prevalence Study. Int J Clin Pediatr Dent. 2009 Jan;2(1):26-9. doi: 10.5005/jp-journals-10005-1037. Epub 2009 Apr 26.
PubMed 25206095Guaba K, Ashima G, Tewari A, Utreja A. Prevalence of malocclusion and abnormal oral habits in North Indian rural children. J Indian Soc Pedod Prev Dent. 1998 Mar;16(1):26-30.
PubMed 11813715Garde JB, Suryavanshi RK, Jawale BA, Deshmukh V, Dadhe DP, Suryavanshi MK. An epidemiological study to know the prevalence of deleterious oral habits among 6 to 12 year old children. J Int Oral Health. 2014 Feb;6(1):39-43. Epub 2014 Feb 26.
PubMed 24653601
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence of Oral Habits in a Group of Primary School Children in Cairo Governorate: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT02944422
- Acronym / sponsor ID
- CEBC-CU-2016-10-142
- Conditions
- Oral Habit
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 624 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Feb 2017 (estimated)
- First posted
- 25 Oct 2016 (estimated)
- 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.
This study is designed to determine the prevalence of oral habits among primary Egyptian school children in Cairo Governorate, Egypt.
Detailed description
This aim of this study is to determine the prevalence of oral habits among primary Egyptian school children in Cairo Governorate, Egypt.
PICO:
P: Egyptian primary school children of 7 - 10 years old
O: Prevalence of oral habits
Primary Outcome: Prevalence of Oral Habit; Device of Measurement: Questionnaire; Unit of Measurement: Binary.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Males | – | –Primary school Egyptian boys from 7-10 years. |
| Females | – | –Primary school Egyptian girls from 7-10 years. |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Primary school Egyptian children.
Key inclusion criteria (2 listed)
- Cooperative children of 7-10 years old
- Children with no intellectual problems
Key exclusion criteria (3 listed)
- Children with orthodontic appliances
- Medically compromised children
- Children of families who refuse to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of Oral Habit
Time frame: 5 months
Measurement that will be used: Questionnaire
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2016.
- Background: PubMed 11813757Shetty SR, Munshi AK. Oral habits in children--a prevalence study. J Indian Soc Pedod Prev Dent. 1998 Jun;16(2):61-6.
- Background: PubMed 20539325Quashie-Williams R, daCosta OO, Isiekwe MC. Oral habits, prevalence and effects on occlusion of 4-15 year old school children in Lagos, Nigeria. Niger Postgrad Med J. 2010 Jun;17(2):113-7.
- Background: PubMed 15080510Onyeaso CO. Oral habits among 7-10 year-old school children in Ibadan, Nigeria. East Afr Med J. 2004 Jan;81(1):16-21. doi: 10.4314/eamj.v81i1.8789.
- Background: PubMed 24326142Lagana G, Masucci C, Fabi F, Bollero P, Cozza P. Prevalence of malocclusions, oral habits and orthodontic treatment need in a 7- to 15-year-old schoolchildren population in Tirana. Prog Orthod. 2013 Jun 14;14:12. doi: 10.1186/2196-1042-14-12.
- Background: PubMed 14703220Kharbanda OP, Sidhu SS, Sundaram K, Shukla DK. Oral habits in school going children of Delhi: a prevalence study. J Indian Soc Pedod Prev Dent. 2003 Sep;21(3):120-4.
- Background: PubMed 25206095M Hegde A, M Xavier A. Childhood Habits: Ignorance is not Bliss- A Prevalence Study. Int J Clin Pediatr Dent. 2009 Jan;2(1):26-9. doi: 10.5005/jp-journals-10005-1037. Epub 2009 Apr 26.
- Background: PubMed 11813715Guaba K, Ashima G, Tewari A, Utreja A. Prevalence of malocclusion and abnormal oral habits in North Indian rural children. J Indian Soc Pedod Prev Dent. 1998 Mar;16(1):26-30.
- Background: PubMed 24653601Garde JB, Suryavanshi RK, Jawale BA, Deshmukh V, Dadhe DP, Suryavanshi MK. An epidemiological study to know the prevalence of deleterious oral habits among 6 to 12 year old children. J Int Oral Health. 2014 Feb;6(1):39-43. Epub 2014 Feb 26.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Randa Youssef, Lecturer contact
Mahmoud Hamdy, Professor study director
Cairo University
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Habit, run by Cairo University.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 25 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yomna Hassan Saad, Bachleor (+201000278120, yomna.hassan@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Oral Habit (time frame: 5 months). 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 NCT02944422, which also lists 8 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 25 Oct 2016.