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Dental CariesOBFNCT03254069

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

A study testing Stainless Steel Crowns in people with Dental Caries, run by Jordan University of Science and Technology at 1 site in Jordan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 4 to 6 yearsHealthy volunteers can take part
Conditions the study is for
Dental Caries
What is being tested?
Stainless Steel Crowns
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteJordan
Study dates
Nov 2011to Dec 2012
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 6 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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
Show all 10Show fewer
  • No gingival inflammation
  • No para functional habits
  • Exclusion Criteria: did not meet the inclusion criteria stated above
  • -

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Jordan1 site

  • Jordan University of Science and Technology

    Irbid, 22110

Other trials in Jordan

About this study

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

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

Read the 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

Conditions
Dental Caries
Being tested
Stainless Steel Crowns
Medical subject headings
Dental Caries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stainless Steel CrownsDevice

    Also called SSCs

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

Study groups in NCT03254069
Study groupRoleWhat they receive
Stainless Steel Crown ArmExperimentalChildren 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
Receives: Device: Stainless Steel Crowns
Control ArmNo interventionA 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).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Occlusal Bite Force (MOBF)

    Occlusal Bite Force will be measured in Newton

    Measured: Six Months post placement

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2017
  2. Study startNov 2011
  3. Primary completionNov 2012
  4. Study completionDec 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03254069
Sponsor's protocol ID
Occlusal Bite Force
Acronym
OBF
Status last verified
Aug 2017
First submitted
8 Apr 2016
Last updated
18 Aug 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 20731734

  • 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.

    PubMed 20396457

  • 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.

    PubMed 21781200

  • 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.

    PubMed 12080313

  • 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.

    PubMed 19207738

  • 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.

    PubMed 14969373

  • 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.

    PubMed 17138373

  • 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.

    PubMed 18328050

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

    PubMed 25905656

  • 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.

    PubMed 20932395

  • 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.

    PubMed 18808544

  • 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.

    PubMed 22518063

  • 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.

    PubMed 18482509

Questions about this trial

What is this clinical trial studying?

A study testing Stainless Steel Crowns in people with Dental Caries, run by Jordan University of Science and Technology at 1 site in Jordan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Occlusal Bite Force (MOBF) (time frame: Six Months post placement). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03254069, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2017.

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