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

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ClinicalTrials.gov Identifier: NCT03608345

Recruitment Status : Completed

First Posted : July 31, 2018

Last Update Posted : July 31, 2018

Sponsor:

Information provided by (Responsible Party):

Aliye Tugce Gurcan, Altinbas University

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
Dental Plaque	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

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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 :	June 2013
Actual Primary Completion Date :	June 2014
Actual Study Completion Date :	June 2014

Groups and Cohorts

Intervention Details:

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

Outcome Measures

Primary Outcome Measures :

DMFT/dft index value changes after applying space maintainers [ Time Frame: 12 months ]
With visual examination DMFT/dft index value changes were recorded to patient files

Secondary Outcome Measures :

Plaque index value changes after applying space maintainers [ Time Frame: 12 months ]
With visual examination and rounded explorer, plaque index value changes were recorded to patient files according to Sillness and Loe.

Eligibility Criteria

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Ages Eligible for Study:	4 Years to 15 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes
Sampling Method:	Probability 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.

Criteria

Inclusion Criteria:

healthy and applied space maintainer patients

Exclusion Criteria:

unhealthy and non-applied space maintainer patients

Contacts and Locations

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): NCT03608345

Sponsors and Collaborators

Altinbas University

Investigators

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

More Information

Publications:

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.

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.

Arikan F, Eronat N, Candan U, Boyacioğlu H. Periodontal conditions associated with space maintainers following two different dental health education techniques. J Clin Pediatr Dent. 2007 Summer;31(4):229-34.

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Responsible Party:	Aliye Tugce Gurcan, Assist. Prof., Altinbas University
ClinicalTrials.gov Identifier:	NCT03608345
Other Study ID Numbers:	Altinbas University
First Posted:	July 31, 2018 Key Record Dates
Last Update Posted:	July 31, 2018
Last Verified:	July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by Aliye Tugce Gurcan, Altinbas University:


oral health dental plaque space maintenance

Additional relevant MeSH terms:

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Dental Plaque Dental Deposits Tooth Diseases Stomatognathic Diseases

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