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

Primary Purpose

Dental Caries

Status
Completed
Phase
Not Applicable
Locations
Jordan
Study Type
Interventional
Intervention
Stainless Steel Crowns
Sponsored by
Jordan University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries

Eligibility Criteria

4 Years - 6 Years (Child)All SexesAccepts Healthy Volunteers

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

-

Sites / Locations

  • Jordan University of Science and Technology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Stainless Steel Crown Arm

Control Arm

Arm Description

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

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).

Outcomes

Primary Outcome Measures

Maximum Occlusal Bite Force (MOBF)
Occlusal Bite Force will be measured in Newton

Secondary Outcome Measures

Full Information

First Posted
April 8, 2016
Last Updated
August 15, 2017
Sponsor
Jordan University of Science and Technology
Collaborators
University of Iowa
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1. Study Identification

Unique Protocol Identification Number
NCT03254069
Brief Title
Occlusal Bite Force Changes After Placement of Stainless Steel Crowns in Children
Acronym
OBF
Official Title
Changes in Occlusal Bite Force Following Placement of Stainless Steel Crowns on Primary Molars in Children
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jordan University of Science and Technology
Collaborators
University of Iowa

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stainless Steel Crown Arm
Arm Type
Experimental
Arm Description
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
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Stainless Steel Crowns
Other Intervention Name(s)
SSCs
Intervention Description
SSCs were placed on children's primary molars, and bite force was registered prior to the study, and periodically after the study.
Primary Outcome Measure Information:
Title
Maximum Occlusal Bite Force (MOBF)
Description
Occlusal Bite Force will be measured in Newton
Time Frame
Six Months post placement

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
arwa Owais, BDS
Organizational Affiliation
Jordan University of Science & Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jordan University of Science and Technology
City
Irbid
ZIP/Postal Code
22110
Country
Jordan

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
20731734
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.
Results Reference
result
PubMed Identifier
20396457
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.
Results Reference
result
PubMed Identifier
21781200
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.
Results Reference
result
PubMed Identifier
12080313
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. doi: 10.1067/mod.2002.122829.
Results Reference
result
PubMed Identifier
19207738
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.
Results Reference
result
PubMed Identifier
14969373
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. doi: 10.17796/jcpd.28.2.j42870t47q4n1715.
Results Reference
result
PubMed Identifier
17138373
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.
Results Reference
result
PubMed Identifier
18328050
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.
Results Reference
result
PubMed Identifier
25905656
Citation
Seale NS, Randall R. The use of stainless steel crowns: a systematic literature review. Pediatr Dent. 2015 Mar-Apr;37(2):145-60.
Results Reference
result
PubMed Identifier
20932395
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.
Results Reference
result
PubMed Identifier
18808544
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.
Results Reference
result
PubMed Identifier
22518063
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.
Results Reference
result
PubMed Identifier
18482509
Citation
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.
Results Reference
result

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

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