Clinical trial NCT03608345: Effects of Fixed and Removable Space Maintainers on Periodontal Health and DMFT/Dft Values
Official title: Effects of Space Maintainers on Oral Health
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dental Plaque
Keywords: oral health
dental plaque
space maintenance
Lead sponsor: Altinbas University
Sponsor class: OTHER
First posted: 2018-07-31
Enrollment: 100
Sex: ALL
Minimum age (years): 4
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: Inclusion Criteria:

* healthy and applied space maintainer patients

Exclusion Criteria:

* unhealthy and non-applied space maintainer patients

Primary outcomes:
measure: DMFT/dft index value changes after applying space maintainers
timeFrame: 12 months
Secondary outcomes:
measure: Plaque index value changes after applying space maintainers
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Altinbas University
name: Aliye Tuğçe Gürcan, Assist.Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.