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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03254069
Other study ID # Occlusal Bite Force
Secondary ID
Status Completed
Phase N/A
First received April 8, 2016
Last updated August 15, 2017
Start date November 2011
Est. completion date December 2012

Study information

Verified date August 2017
Source Jordan University of Science and Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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


Recruitment information / eligibility

Status Completed
Enrollment 44
Est. completion date December 2012
Est. primary completion date November 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 4 Years to 6 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Jordan Jordan University of Science and Technology Irbid

Sponsors (2)

Lead Sponsor Collaborator
Jordan University of Science and Technology University of Iowa

Country where clinical trial is conducted

Jordan, 

References & Publications (13)

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. — View 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: — View Citation

Koc D, Dogan A, Bek B. Bite force and influential factors on bite force measurements: a literature review. Eur J Dent. 2010 Apr;4(2):223-32. — View 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. — View Citation

Ohira A, Ono Y, Yano N, Takagi Y. The effect of chewing exercise in preschool children on maximum bite force and masticatory performance. Int J Paediatr Dent. 2012 Mar;22(2):146-53. doi: 10.1111/j.1365-263X.2011.01162.x. Epub 2011 Jul 22. — View Citation

Oueis H. Factors affecting masticatory performance of Japanese children. Int J Paediatr Dent. 2009 May;19(3):201-5. doi: 10.1111/j.1365-263X.2008.00965.x. Epub 2009 Jan 16. — View 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. — View Citation

Owens S, Buschang PH, Throckmorton GS, Palmer L, English J. Masticatory performance and areas of occlusal contact and near contact in subjects with normal occlusion and malocclusion. Am J Orthod Dentofacial Orthop. 2002 Jun;121(6):602-9. — View Citation

Seale NS, Randall R. The use of stainless steel crowns: a systematic literature review. Pediatr Dent. 2015 Mar-Apr;37(2):145-60. Review. — View 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. — View Citation

Serra MD, Gambareli FR, Gavião MB. A 1-year intraindividual evaluation of maximum bite force in children wearing a removable partial dental prosthesis. J Dent Child (Chic). 2007 Sep-Dec;74(3):171-6. — View Citation

Tsai HH. Maximum bite force and related dental status in children with deciduous dentition. J Clin Pediatr Dent. 2004 Winter;28(2):139-42. — View 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. — View Citation

* Note: There are 13 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Maximum Occlusal Bite Force (MOBF) Occlusal Bite Force will be measured in Newton Six Months post placement
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