NCT03027765

Brief Summary

The purpose of the study is

  • To determine the Prevalence of constructed space maintainers at Pediatric Dentistry and Dental Public Health Department, Faculty of Oral and Dental Medicine, Cairo University.
  • To assess the knowledge, attitude and awareness of constructed space maintainers for pediatric patients' guardians at Pediatric Dentistry and Dental Public Health Department, Faculty of Oral and Dental Medicine, Cairo University. and \- To assess the knowledge, attitude and practice of pediatric dentists towards use of space maintainers in children, at Pediatric Dentistry and Dental Public Health Department, Faculty of Oral and Dental Medicine, Cairo University.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2017

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 23, 2017

Completed
9 days until next milestone

Study Start

First participant enrolled

February 1, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

January 24, 2017

Status Verified

January 1, 2017

Enrollment Period

6 months

First QC Date

January 18, 2017

Last Update Submit

January 20, 2017

Conditions

Tooth Loss

Outcome Measures

Primary Outcomes (1)

  • Prevalence of constructed space maintainers

    Device for measurement through Visual examination and unit is Binary (Yes, No) and MCQ

    6 months

Study Arms (2)

Egyptian children

Population1: Egyptian children with constructed space maintainers at Cairo University.

Pediatric dentists

Population2: Pediatric dentists at Cairo University.

Eligibility Criteria

Age2 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Egyptian children with constructed space maintainers and their guardians attending Pediatric Dentistry and Dental Public Health Department, Faculty of Oral and Dental Medicine, Cairo University Both gender are included and Pediatric dentists at Pediatric Dentistry and Dental Public Health Department, Faculty of Oral and Dental Medicine, Cairo University.

You may qualify if:

  • All patients with constructed space maintainers
  • Positive patient's acceptance for participation in the study.
  • Both genders are included.
  • Children Medically free from any systemic disease.

You may not qualify if:

  • Patients with orthodontic appliances.
  • Patient having one of the different following habit thumb sucking, lip biting, tongue thrusting etc.
  • nd population is pediatric dentists:
  • All Pediatric dentists having master degree and above.
  • Pediatric dentists refused to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (16)

  • Ari T. Follow-up problems with fixed appliances in pediatric dentistry. N Y State Dent J. 2015 Mar;81(2):16-20.

    PMID: 25928968BACKGROUND

  • Asiry MA. Occlusal Status among 12-16 Year-Old School Children in Riyadh, Saudi Arabia. J Int Oral Health. 2015 May;7(5):20-3.

    PMID: 26028897BACKGROUND

  • Baroni C, Franchini A, Rimondini L. Survival of different types of space maintainers. Pediatr Dent. 1994 Sep-Oct;16(5):360-1. No abstract available.

    PMID: 7831141BACKGROUND

  • Brothwell DJ. Guidelines on the use of space maintainers following premature loss of primary teeth. J Can Dent Assoc. 1997 Nov;63(10):753, 757-60, 764-6.

    PMID: 9401297BACKGROUND

  • Dhar V, Jain A, Van Dyke TE, Kohli A. Prevalence of gingival diseases, malocclusion and fluorosis in school-going children of rural areas in Udaipur district. J Indian Soc Pedod Prev Dent. 2007 Apr-Jun;25(2):103-5. doi: 10.4103/0970-4388.33458.

    PMID: 17660647BACKGROUND

  • Dogan MC, Dogan SK, Kendi E. Complications of pediatric denture misuse: a case report. Oral Health Prev Dent. 2005;3(2):127-30.

    PMID: 16173390BACKGROUND

  • Green J. Mind the gap: Overview of space maintaining appliances. Dent Nurs 2015; 11(1):24-7.

    BACKGROUND

  • Kapala JT. Interceptive orthodontics and management of space problems. In: Braham RL, Morris ME. Textbook of Pediatric Dentistry, Eds. Baltimore, London, William & Wilkins Co. 1980: pp 320-356.

    BACKGROUND

  • Keski-Nisula K, Hernesniemi R, Heiskanen M, Keski-Nisula L, Varrela J. Orthodontic intervention in the early mixed dentition: a prospective, controlled study on the effects of the eruption guidance appliance. Am J Orthod Dentofacial Orthop. 2008 Feb;133(2):254-60; quiz 328.e2. doi: 10.1016/j.ajodo.2006.05.039.

    PMID: 18249292BACKGROUND

  • Laing E, Ashley P, Naini FB, Gill DS. Space maintenance. Int J Paediatr Dent. 2009 May;19(3):155-62. doi: 10.1111/j.1365-263X.2008.00951.x.

    PMID: 19385999BACKGROUND

  • Leite-Cavalcanti A,de Alencar, Benzerra PK,Garcia A., Prevalence of early loss of primary molars in school children in Brazil. Pak Oral Dent J 2008; 28:113-6.

    BACKGROUND

  • Petrunov V. Epidemiological research of malocclusions and the need of orthodontic treatment among the Bulgarians in the mixed to permanent dentition period, Disertation, Sofia 2012, p.62

    BACKGROUND

  • Qudeimat MA, Fayle SA. The use of space maintainers at a UK pediatric dentistry department. ASDC J Dent Child. 1999 Nov-Dec;66(6):383-6.

    PMID: 10656119BACKGROUND

  • Ronnerman A, Thilander B. A longitudinal study on the effect of unilateral extraction of primary molars. Scand J Dent Res. 1977 Jul;85(5):362-72. doi: 10.1111/j.1600-0722.1977.tb01516.x.

    PMID: 268677BACKGROUND

  • Ronnerman A, Thilander B. Facial and dental arch morphology in children with and without early loss of deciduous molars. Am J Orthod. 1978 Jan;73(1):47-58. doi: 10.1016/0002-9416(78)90101-x. No abstract available.

    PMID: 271472BACKGROUND

  • Talekar BS, Rozier RG, Slade GD, Ennett ST. Parental perceptions of their preschool-aged children's oral health. J Am Dent Assoc. 2005 Mar;136(3):364-72; quiz 381. doi: 10.14219/jada.archive.2005.0179.

    PMID: 15819352BACKGROUND

MeSH Terms

Conditions

Tooth Loss

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesTooth Diseases

Study Officials

  • Sherine Ezz Eldin Taha, Professor

    Cairo University

    STUDY DIRECTOR

Central Study Contacts

Yara AbdulWahab AbdulHameed Moawad, bachelor

CONTACT

+201116108317yaramoawad@rocketmail.com

Fatma Korany, Lecturer

CONTACT

01006753265fatmadent@hotmail.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigaror

Study Record Dates

First Submitted

January 18, 2017

First Posted

January 23, 2017

Study Start

February 1, 2017

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

January 24, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share