Effects of Fixed and Removable Space Maintainers on Periodontal Health and DMFT/Dft Values

Sponsor
Altinbas University (Other)
Overall Status
Completed
CT.gov ID
NCT03608345
Collaborator
(none)
100
12

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: space maintainer

Detailed Description

The study was approved by the Ethics Committee of the Istanbul University Faculty of Dentistry (No:2014/8) and was carried out in agreement with the Declaration of Helsinki principles. This study conducted 104 patient whose age between the range of 4-15 years were chosen to applied fixed (band and loop, palatal arch, lingual arch) or removable space maintainers in Istanbul University Faculty of Dentistry Department of Pediatric Dentistry were followed between years of 2013-2014. Totally, four of the patients excluded due to systemically and genetically disorder.

In primary and mixed dentition, dft index was used and in permanent dentition DMFT index was used. Longevity time in the mouth, the number of developing new caries were evaluated and DMFT/dft and plaque index were compared.

Study Design

Study Type:
Observational
Actual Enrollment :
100 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Effects of Space Maintainers on Oral Health
Actual Study Start Date :
Jun 1, 2013
Actual Primary Completion Date :
Jun 1, 2014
Actual Study Completion Date :
Jun 1, 2014

Outcome Measures

Primary Outcome Measures

  1. DMFT/dft index value changes after applying space maintainers [12 months]

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

Secondary Outcome Measures

  1. Plaque index value changes after applying space maintainers [12 months]

    With visual examination and rounded explorer, plaque index value changes were recorded to patient files according to Sillness and Loe.

Eligibility Criteria

Criteria

Ages Eligible for Study:
4 Years to 15 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • healthy and applied space maintainer patients
Exclusion Criteria:
  • unhealthy and non-applied space maintainer patients

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Altinbas University

Investigators

  • Principal Investigator: Aliye Tuğçe Gürcan, Assist.Prof., Altinbas University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Aliye Tugce Gurcan, Assist. Prof., Altinbas University
ClinicalTrials.gov Identifier:
NCT03608345
Other Study ID Numbers:
  • Altinbas University
First Posted:
Jul 31, 2018
Last Update Posted:
Jul 31, 2018
Last Verified:
Jul 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Aliye Tugce Gurcan, Assist. Prof., Altinbas University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 31, 2018