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Completed

NCT Number: NCT03254069

Occlusal Bite Force Changes After Placement of Stainless Steel Crowns in Children

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

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Key information

Age range

4 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jordan University of Science and Technology

Irbid, 22110, Jordan

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Stainless Steel Crowns

Device

SSCs were placed on children's primary molars, and bite force was registered prior to the study, and periodically after the study.

Other names: SSCs

Primary outcomes

  1. Maximum Occlusal Bite Force (MOBF)

    Time frame: Six Months post placement

    Occlusal Bite Force will be measured in Newton

Sponsors and collaborators

Lead sponsor

Jordan University of Science and Technology

Other

Collaborators

  • University of Iowa

Registry information

Official study title

Changes in Occlusal Bite Force Following Placement of Stainless Steel Crowns on Primary Molars in Children

Acronym: OBF

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Aug 18, 2017
Registry last updated
Aug 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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