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

August 15, 2017 updated by: Arwa Issa Owais, Jordan University of Science and Technology

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Jordan
      • Irbid, Jordan, 22110
        • Jordan University of Science and Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stainless Steel Crown Arm
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
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
No Intervention: Control Arm
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Occlusal Bite Force (MOBF)
Time Frame: Six Months post placement
Occlusal Bite Force will be measured in Newton
Six Months post placement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jordan University of Science and Technology

Collaborators

University of Iowa

Investigators

  • Principal Investigator: arwa Owais, BDS, Jordan University of Science & Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

April 8, 2016

First Submitted That Met QC Criteria

August 15, 2017

First Posted (Actual)

August 18, 2017

Study Record Updates

Last Update Posted (Actual)

August 18, 2017

Last Update Submitted That Met QC Criteria

August 15, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Occlusal Bite Force

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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