NCT03254069

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

April 8, 2016

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

August 18, 2017

Completed
Last Updated

August 18, 2017

Status Verified

August 1, 2017

Enrollment Period

1 year

First QC Date

April 8, 2016

Last Update Submit

August 15, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Maximum Occlusal Bite Force (MOBF)

    Occlusal Bite Force will be measured in Newton

    Six Months post placement

Study Arms (2)

Stainless Steel Crown Arm

EXPERIMENTAL

Children with SSCs placed and followed longitudinal. Consent was obtained from all parents and verbal assent was obtained. The following data was collected: Demographic Data of the Children, clinical examination, radiographs, treatment planning, details of stainless steel crowns placement, OBF measurements were made before the SSC placement and periodically post placement

Device: Stainless Steel Crowns

Control Arm

NO INTERVENTION

A second group consisted of twenty-two children (11 females and 11 males; a mean age of 5.20 ± 0.36 years) were selected to act as a control sample and received no dental treatment. MOBF was recorded in these subjects at T0 and T5 (6 months after).

Interventions

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

Also known as: SSCs
Stainless Steel Crown Arm

Eligibility Criteria

Age4 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jordan University of Science and Technology

Irbid, 22110, Jordan

Location

Related Publications (13)

  • 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.

  • 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.

  • 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.

  • 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. doi: 10.1067/mod.2002.122829.

  • 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.

  • Tsai HH. Maximum bite force and related dental status in children with deciduous dentition. J Clin Pediatr Dent. 2004 Winter;28(2):139-42. doi: 10.17796/jcpd.28.2.j42870t47q4n1715.

  • 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.

  • 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.

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

  • 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.

  • 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.

  • 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.

  • Serra MD, Gambareli FR, Gaviao 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.

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • arwa Owais, BDS

    Jordan University of Science & Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 8, 2016

First Posted

August 18, 2017

Study Start

November 1, 2011

Primary Completion

November 1, 2012

Study Completion

December 1, 2012

Last Updated

August 18, 2017

Record last verified: 2017-08

Locations