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The Prevalence of Malocclusion Development in a Group of Egyptian Children With Digit Sucking Aged 3 to 6 Years

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ClinicalTrials.gov Identifier: NCT02943200
Recruitment Status : Not yet recruiting
First Posted : October 24, 2016
Last Update Posted : November 1, 2016
Sponsor:
Information provided by (Responsible Party):
Heba Ashraf, Cairo University

Brief 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.

Condition or disease
Children With Digit Sucking

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 Type : Observational
Estimated Enrollment : 185 participants
Time Perspective: Cross-Sectional
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
Study Start Date : October 2016
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : July 2017



Primary Outcome Measures :
  1. Anterior open bite [ Time Frame: 6 months ]
    Measured using a divider and the measurement is transferred onto a ruler. measuring unit is mm.

  2. Over bite. [ Time Frame: 6 months ]
    measured using a periodontal probe and the measurement is transferred onto a ruler. measuring unit mm.

  3. Over jet. [ Time Frame: 6 months ]
    measured using a periodontal probe and the measurement is transferred onto a ruler. measuring unit mm.

  4. Anterior and posterior cross bite. [ Time Frame: 6 months ]
    Observed visually.Binary units: (yes/no)



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Ages Eligible for Study:   3 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
population is limited to Egyptian children who are aged from 3 to 6 years and are thumb suckers. both genders are included
Criteria

Inclusion Criteria:

  • Children between ages 3 to 6 years.
  • Children those are medically free.
  • Both genders are included.
  • Egyptian children

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02943200


Contacts
Contact: Heba Ashraf, bachelor 01123777705 heba_ashraf@dentistry.cu.edu.eg
Contact: Randa Youssef, lecturer

Sponsors and Collaborators
Cairo University
Investigators
Study Director: Mahmoud Hamdy, professor Cairo University
Study Director: Salah Behery, professor Cairo University

Publications:
Fisher, J.E.: Evidence-Based Psychotherapy. Springer, Reno, NV, 2006
Jajoo 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.
Marwah 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

Responsible Party: Heba Ashraf, principal investigator, Cairo University
ClinicalTrials.gov Identifier: NCT02943200     History of Changes
Other Study ID Numbers: protocol89
First Posted: October 24, 2016    Key Record Dates
Last Update Posted: November 1, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Malocclusion
Tooth Diseases
Stomatognathic Diseases