Children With Digit SuckingNCT02943200
The Prevalence of Malocclusion Development in a Group of Egyptian Children With Digit Sucking Aged 3 to 6 Years
An observational study of Children With Digit Sucking, run by Cairo University.
Trial summary
The purpose of the study is to determine the prevalence of malocclusion among a group of Egyptian children with digit sucking aged 3 to 6 years. Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Children With Digit Sucking
- How many people
- 185 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Jul 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 3 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: population is limited to Egyptian children who are aged from 3 to 6 years and are thumb suckers. both genders are included
Who may be able to join
- Children between ages 3 to 6 years.
- Children those are medically free.
- Both genders are included.
- Egyptian children
Who cannot join
- History of an obvious alternative cause for malocclusion (e.g. trauma, syndromes).
- Participants exposed to thumb sucking prevention programs.
- Participants who underwent orthodontic treatment for his/her malocclusion.
- Participants' caregivers refuse to give consent.
Trial locations and contacts
No sites are listed yet.
Randa Youssef, lecturer contact
About this study
Official title: The Prevalence of Malocclusion Development in a Group of Egyptian Children With Digit Sucking Aged 3 to 6 Years: A Cross Sectional Study
The purpose of the study is to determine the prevalence of malocclusion among a group of Egyptian children with digit sucking aged 3 to 6 years.
Read the detailed description
The purpose of the study is to determine the prevalence of malocclusion among a group of Egyptian children with digit sucking aged 3 to 6 years.
PICO:
Population: Egyptian Children with digit sucking aged 3 to 6 years. Outcome: Development of malocclusion.
- Conditions
- Children With Digit Sucking
What is being measured
The primary outcome is the main question the study is designed to answer.
Anterior open bite
Measured using a divider and the measurement is transferred onto a ruler. measuring unit is mm.
Measured: 6 months
Over bite.
measured using a periodontal probe and the measurement is transferred onto a ruler. measuring unit mm.
Measured: 6 months
Over jet.
measured using a periodontal probe and the measurement is transferred onto a ruler. measuring unit mm.
Measured: 6 months
Anterior and posterior cross bite.
Observed visually.Binary units: (yes/no)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionJun 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Children With Digit SuckingStudies 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
- 185 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Ashraf, Cairo University
- Investigators
- Mahmoud Hamdy, professor, Study director, Cairo UniversitySalah Behery, professor, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02943200
- Sponsor's protocol ID
- protocol89
- Status last verified
- Oct 2016
- First submitted
- 15 Oct 2016
- Last updated
- 1 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Burford D, Noar JH. The causes, diagnosis and treatment of anterior open bite. Dent Update. 2003 Jun;30(5):235-41. doi: 10.12968/denu.2003.30.5.235.
PubMed 12861760Greenleaf S, Mink J. A retrospective study of the use of the Bluegrass appliance in the cessation of thumb habits. Pediatr Dent. 2003 Nov-Dec;25(6):587-90.
PubMed 14733476Kamdar RJ, Al-Shahrani I. Damaging oral habits. J Int Oral Health. 2015 Apr;7(4):85-7.
PubMed 25954079Larsson E. Sucking, chewing, and feeding habits and the development of crossbite: a longitudinal study of girls from birth to 3 years of age. Angle Orthod. 2001 Apr;71(2):116-9. doi: 10.1043/0003-3219(2001)0712.0.CO;2.
PubMed 11302587Moimaz SA, Garbin AJ, Lima AM, Lolli LF, Saliba O, Garbin CA. Longitudinal study of habits leading to malocclusion development in childhood. BMC Oral Health. 2014 Aug 4;14:96. doi: 10.1186/1472-6831-14-96.
PubMed 25091288Urzal V, Braga AC, Ferreira AP. Oral habits as risk factors for anterior open bite in the deciduous and mixed dentition - cross-sectional study. Eur J Paediatr Dent. 2013 Dec;14(4):299-302.
PubMed 24313582Warren JJ, Bishara SE. Duration of nutritive and nonnutritive sucking behaviors and their effects on the dental arches in the primary dentition. Am J Orthod Dentofacial Orthop. 2002 Apr;121(4):347-56. doi: 10.1067/mod.2002.121445.
PubMed 11997758Warren JJ, Levy SM, Nowak AJ, Tang S. Non-nutritive sucking behaviors in preschool children: a longitudinal study. Pediatr Dent. 2000 May-Jun;22(3):187-91.
PubMed 10846728Fisher, J.E.: Evidence-Based Psychotherapy. Springer, Reno, NV, 2006
Ize-Iyamu IN, Isiekwe MC. Prevalence and factors associated with anterior open bite in 2 to 5 year old children in Benin city, Nigeria. Afr Health Sci. 2012 Dec;12(4):446-51. doi: 10.4314/ahs.v12i4.8.
PubMed 23513076Jajoo S et al. (2015). Oral Habits in School Going Children of Pune: A Prevalence Study. Journal of International Oral Health; 7(10):1-6.
Jyoti S, Pavanalakshmi GP. Nutritive and Non-Nutritive Sucking Habits - Effect on the Developing Oro-Facial Complex; A Review. Dentistry 2014; 4(3)1-4.
Katz CR, Rosenblatt A, Gondim PP. Nonnutritive sucking habits in Brazilian children: effects on deciduous dentition and relationship with facial morphology. Am J Orthod Dentofacial Orthop. 2004 Jul;126(1):53-7. doi: 10.1016/j.ajodo.2003.06.011.
PubMed 15224059Marwah N. Oral Habits. In: Text book of Pediatric Dentistry. 2nd ed. Jaypee Brothers Medical publishers; 2009. p. 281-298.
W.H. Littlefield, B.D.S. (Durham), H.D.D. (Edinburgh). Thumb-sucking and its relationship to malocclusion in children. American Journal of Orthodontics, Volume 38, Issue 4, 293 - 300. 1952
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence of Malocclusion Development in a Group of Egyptian Children With Digit Sucking Aged 3 to 6 Years: A Cross Sectional Study
- ClinicalTrials.gov ID
- NCT02943200
- Acronym / sponsor ID
- protocol89
- Conditions
- Children With Digit Sucking
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 185 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 24 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.
The purpose of the study is to determine the prevalence of malocclusion among a group of Egyptian children with digit sucking aged 3 to 6 years.
Detailed description
The purpose of the study is to determine the prevalence of malocclusion among a group of Egyptian children with digit sucking aged 3 to 6 years.
PICO:
Population: Egyptian Children with digit sucking aged 3 to 6 years. Outcome: Development of malocclusion.
Study design
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- population is limited to Egyptian children who are aged from 3 to 6 years and are thumb suckers. both genders are included
Key inclusion criteria (4 listed)
- Children between ages 3 to 6 years.
- Children those are medically free.
- Both genders are included.
- Egyptian children
Key exclusion criteria (4 listed)
- History of an obvious alternative cause for malocclusion (e.g. trauma, syndromes).
- Participants exposed to thumb sucking prevention programs.
- Participants who underwent orthodontic treatment for his/her malocclusion.
- Participants' caregivers refuse to give consent.
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
Anterior open bite
Time frame: 6 months
Measured using a divider and the measurement is transferred onto a ruler. measuring unit is mm.
Over bite.
Time frame: 6 months
measured using a periodontal probe and the measurement is transferred onto a ruler. measuring unit mm.
Over jet.
Time frame: 6 months
measured using a periodontal probe and the measurement is transferred onto a ruler. measuring unit mm.
Anterior and posterior cross bite.
Time frame: 6 months
Observed visually.Binary units: (yes/no)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2016.
- Background: PubMed 12861760Burford D, Noar JH. The causes, diagnosis and treatment of anterior open bite. Dent Update. 2003 Jun;30(5):235-41. doi: 10.12968/denu.2003.30.5.235.
- Background: PubMed 14733476Greenleaf S, Mink J. A retrospective study of the use of the Bluegrass appliance in the cessation of thumb habits. Pediatr Dent. 2003 Nov-Dec;25(6):587-90.
- Background: PubMed 25954079Kamdar RJ, Al-Shahrani I. Damaging oral habits. J Int Oral Health. 2015 Apr;7(4):85-7.
- Background: PubMed 11302587Larsson E. Sucking, chewing, and feeding habits and the development of crossbite: a longitudinal study of girls from birth to 3 years of age. Angle Orthod. 2001 Apr;71(2):116-9. doi: 10.1043/0003-3219(2001)0712.0.CO;2.
- Background: PubMed 25091288Moimaz SA, Garbin AJ, Lima AM, Lolli LF, Saliba O, Garbin CA. Longitudinal study of habits leading to malocclusion development in childhood. BMC Oral Health. 2014 Aug 4;14:96. doi: 10.1186/1472-6831-14-96.
- Background: PubMed 24313582Urzal V, Braga AC, Ferreira AP. Oral habits as risk factors for anterior open bite in the deciduous and mixed dentition - cross-sectional study. Eur J Paediatr Dent. 2013 Dec;14(4):299-302.
- Background: PubMed 11997758Warren JJ, Bishara SE. Duration of nutritive and nonnutritive sucking behaviors and their effects on the dental arches in the primary dentition. Am J Orthod Dentofacial Orthop. 2002 Apr;121(4):347-56. doi: 10.1067/mod.2002.121445.
- Background: PubMed 10846728Warren JJ, Levy SM, Nowak AJ, Tang S. Non-nutritive sucking behaviors in preschool children: a longitudinal study. Pediatr Dent. 2000 May-Jun;22(3):187-91.
- BackgroundFisher, J.E.: Evidence-Based Psychotherapy. Springer, Reno, NV, 2006
- Background: PubMed 23513076Ize-Iyamu IN, Isiekwe MC. Prevalence and factors associated with anterior open bite in 2 to 5 year old children in Benin city, Nigeria. Afr Health Sci. 2012 Dec;12(4):446-51. doi: 10.4314/ahs.v12i4.8.
- BackgroundJajoo S et al. (2015). Oral Habits in School Going Children of Pune: A Prevalence Study. Journal of International Oral Health; 7(10):1-6.
- BackgroundJyoti S, Pavanalakshmi GP. Nutritive and Non-Nutritive Sucking Habits - Effect on the Developing Oro-Facial Complex; A Review. Dentistry 2014; 4(3)1-4.
- Individual participant dataSharing planned: No
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
Salah Behery, professor study director
Cairo University
Questions about this trial
What is this clinical trial studying?
An observational study of Children With Digit Sucking, 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 4 inclusion and 4 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 1 Nov 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 Heba Ashraf, bachelor (01123777705, heba_ashraf@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anterior open bite (time frame: 6 months). The study lists 4 primary outcomes in all. 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 NCT02943200, which also lists 15 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 1 Nov 2016.