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

Dental Plaque Clinical Trial

Official title:

Effects of Space Maintainers on Oral Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03608345
• Other study ID #: Altinbas University
• Status: Completed
• Start date: June 2013
• Est. completion date: June 2014

Study information

• Verified date: July 2018
• Source: Altinbas University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 15 Years

Eligibility

Inclusion Criteria:

• healthy and applied space maintainer patients

Exclusion Criteria:

• unhealthy and non-applied space maintainer patients

Related Conditions & MeSH terms

• Dental Plaque

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Altinbas University

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Plaque index value changes after applying space maintainers	With visual examination and rounded explorer, plaque index value changes were recorded to patient files according to Sillness and Loe.	12 months