NCT03608345

Brief Summary

Space maintainers are appliances that applied when primary teeth were lost prematurely because of many reasons such as tooth decay, trauma, lack of germ of permanent tooth.4 Space problems play an important role in practice of dentistry and also understanding of the dental development in the primary and mixed dentitions could help to intercept the malocclusion.The aim of this study is to evaluate the effects of applied space maintainers on periodontal health and dental status after teeth missing in pediatric dentistry clinic.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2013

Shorter than P25 for all trials

Status
completed

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

Study Start

First participant enrolled

June 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

July 2, 2018

Completed
29 days until next milestone

First Posted

Study publicly available on registry

July 31, 2018

Completed
Last Updated

July 31, 2018

Status Verified

July 1, 2018

Enrollment Period

1 year

First QC Date

July 2, 2018

Last Update Submit

July 24, 2018

Conditions

Keywords

oral healthdental plaquespace maintenance

Outcome Measures

Primary Outcomes (1)

  • DMFT/dft index value changes after applying space maintainers

    With visual examination DMFT/dft index value changes were recorded to patient files

    12 months

Secondary Outcomes (1)

  • Plaque index value changes after applying space maintainers

    12 months

Interventions

Space maintainers are applied after the missing teeth in pediatric dentistry for protection of size of extracted area.

Eligibility Criteria

Age4 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

100 patient whose age between a range of 4-15 years due to having early loss of teeth and were treated with fixed and removable space maintainers in Istanbul University Faculty of Dentistry Department of Pediatric Dentistry were included to this study.

You may qualify if:

  • healthy and applied space maintainer patients

You may not qualify if:

  • unhealthy and non-applied space maintainer patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Arikan V, Kizilci E, Ozalp N, Ozcelik B. Effects of Fixed and Removable Space Maintainers on Plaque Accumulation, Periodontal Health, Candidal and Enterococcus Faecalis Carriage. Med Princ Pract. 2015;24(4):311-7. doi: 10.1159/000430787. Epub 2015 Jun 4.

    PMID: 26044443BACKGROUND
  • American Academy on Pediatric Dentistry Clinical Affairs Committee-Developing Dentition Subcommittee; American Academy on Pediatric Dentistry Council on Clinical Affairs. Guideline on management of the developing dentition and occlusion in pediatric dentistry. Pediatr Dent. 2008-2009;30(7 Suppl):184-95. No abstract available.

    PMID: 19216419BACKGROUND
  • Arikan F, Eronat N, Candan U, Boyacioglu H. Periodontal conditions associated with space maintainers following two different dental health education techniques. J Clin Pediatr Dent. 2007 Summer;31(4):229-34. doi: 10.17796/jcpd.31.4.9588m43n027t560n.

    PMID: 19161056BACKGROUND

MeSH Terms

Conditions

Dental Plaque

Condition Hierarchy (Ancestors)

Dental DepositsTooth DiseasesStomatognathic Diseases

Study Officials

  • Aliye Tuğçe Gürcan, Assist.Prof.

    Altinbas University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof.

Study Record Dates

First Submitted

July 2, 2018

First Posted

July 31, 2018

Study Start

June 1, 2013

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

July 31, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share