Clinical trial NCT03254069: Occlusal Bite Force Changes After Placement of Stainless Steel Crowns in Children
Official title: Changes in Occlusal Bite Force Following Placement of Stainless Steel Crowns on Primary Molars in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Lead sponsor: Jordan University of Science and Technology
Sponsor class: OTHER
Collaborators: name: University of Iowa
First posted: 2017-08-18
Enrollment: 44
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to determine if restoring primary molars with SSCs would improve children's OBF.

Detailed description: Occlusal bite force (OBF) is an indicator of the functional status of the masticatory system. The level of maximum occlusal bite force (MOBF) results from the combined action of the jaw elevator muscles modified by jaw biomechanics and reflex mechanisms. The measurement of OBF has been widely used in dentistry to provide useful data for the evaluation of jaw muscle function and activity as well as effectiveness of prosthetic therapy.

Many indicators have been believed to assess the functional status of the masticatory system, such as body size, bite force, number of functional tooth units, and the occlusal contact area. Dental status formed with dental fillings, dentures, position and the number of teeth is an important factor in the value of the OBF.

Many studies were conducted to evaluate the effect of dental caries on OBF. Tsai et al. found a negative correlation between MOBF and the number of decayed teeth. Su et al. reported that the overall tooth decay was not related to the strength of OBF. They suggested that the severity of tooth decay may be more important than the number of teeth exhibiting decay.

Stainless Steel Crowns (SSCs) are considered the treatment of choice for severely decayed but restorable primary molars. A recent systematic review by Seale and Randall confirmed their previous work and reviews and appeared to continue to be supportive and in favor of SSCs.

SSCs has been blamed for premature contact related discomfort in the first few weeks after placement of SSCs. Zee and Amerongen reported that premature contacting SSC restored teeth will equilibrate over time and return to pretreatment levels in 15 to 30 days.

Several opinions have been reported by parents, children and dentists regarding the improved mastication efficiency after placement of the SSCs. However, the effects of SSCs placement on primary molars on OBF have not yet been investigated

Eligibility criteria: Inclusion Criteria:- Caucasian

* Healthy child
* In the primary dentition stage
* Class I occlusion
* No facial asymmetry
* No cross bite
* Have caries in the eight primary molars indicating placement of SSCs, with no reported pain on biting and no previous restorations
* No gingival inflammation
* No para functional habits

Exclusion Criteria: did not meet the inclusion criteria stated above

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Primary outcomes:
measure: Maximum Occlusal Bite Force (MOBF)
timeFrame: Six Months post placement
Secondary outcomes:
Other outcomes:
Locations:
city: Irbid
country: Jordan
facility: Jordan University of Science and Technology
Study officials:
affiliation: Jordan University of Science & Technology
name: arwa Owais, BDS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mountain G, Wood D, Toumba J. Bite force measurement in children with primary dentition. Int J Paediatr Dent. 2011 Mar;21(2):112-8. doi: 10.1111/j.1365-263X.2010.01098.x. Epub 2010 Aug 20.
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citation: Seale NS. Stainless steel crowns improve success rate of root canal treatment in primary teeth. J Evid Based Dent Pract. 2005 Dec;5(4):205-6. doi: 10.1016/j.jebdp.2005.09.011. No abstract available.
citation: Atieh M. Stainless steel crown versus modified open-sandwich restorations for primary molars: a 2-year randomized clinical trial. Int J Paediatr Dent. 2008 Sep;18(5):325-32. doi: 10.1111/j.1365-263X.2007.00900.x. Epub 2008 Mar 6.
citation: Seale NS, Randall R. The use of stainless steel crowns: a systematic literature review. Pediatr Dent. 2015 Mar-Apr;37(2):145-60.
citation: van der Zee V, van Amerongen WE. Short communication: Influence of preformed metal crowns (Hall technique) on the occlusal vertical dimension in the primary dentition. Eur Arch Paediatr Dent. 2010 Oct;11(5):225-7. doi: 10.1007/BF03262751.
citation: Kindelan SA, Day P, Nichol R, Willmott N, Fayle SA; British Society of Paediatric Dentistry. UK National Clinical Guidelines in Paediatric Dentistry: stainless steel preformed crowns for primary molars. Int J Paediatr Dent. 2008 Nov;18 Suppl 1:20-8. doi: 10.1111/j.1365-263X.2008.00935.x.
citation: Owais AI, Shaweesh M, Abu Alhaija ES. Maximum occusal bite force for children in different dentition stages. Eur J Orthod. 2013 Aug;35(4):427-33. doi: 10.1093/ejo/cjs021. Epub 2012 Apr 19.
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