The Effects of Stainless Steel Crowns Applied With Hall Technique on Occlusal Vertical Dimension

Sponsor
Bezmialem Vakif University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03010618
Collaborator
(none)
125
2
1
34.2
62.5
1.8

Study Details

Study Description

Brief Summary

In recent years restoring carious of fractured primary teeth with stainless steel crowns (SSC) has became more popular than ever. On the other hand the traditional operative approach of complete removal of caries is steadily losing support due to successful results with materials of high microleakage resistance.

Treatment time and pain control in asymptomatic teeth has always been a problem in children. Hall technique is a minimally invasive treatment protocol that doesn't require local anesthesia, use of rotating devices for caries removal to restore primary teeth with SSC.

But this protocol also raised questions in the scientific community about its possible effects on the dentition and temporomandibular joint (TMJ) for causing primary occlusal contact and increasing vertical dimension.

The aim of our research is to study the effects of Hall technique's premature occlusal contact on TMJ.

Condition or Disease Intervention/Treatment Phase
  • Other: Hall technique stainless steel crowns
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
125 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Hall Teknik Ile Uygulanan Paslanmaz Celik kronların Okluzal Dikey Boyuta Etkilerinin değerlendirilmesi
Actual Study Start Date :
Jan 24, 2017
Anticipated Primary Completion Date :
Dec 1, 2019
Anticipated Study Completion Date :
Dec 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Other: Study Group

Other: Hall technique stainless steel crowns
Primary carious tooth will be treated with stainless steel crowns without local anesthesia or caries removal and the increase in the occlusal vertical dimension will be monitored in two subsequent appointments with measuring canine overbite.

Outcome Measures

Primary Outcome Measures

  1. Complete canine overbite return [30 days]

    The length of overbite between upper and lower canines will be measured at beginning of the study with marking the overlapping contact point of the upper left canine and length of a straight line to the tip of the lower left canine will be recorded in mm with a standard WHO gingival probe. Full return to this level will be considered as "Complete canine overbite return" and failure to reach this level will in 30 days will require the patient to be scheduled for an extra recall in every 2 weeks until overbite returns to the pretreatment level.

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Years to 8 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • No systemical illness

  • Willing to come to control appointments

  • No symptoms of pulpal inflammation

  • To have at least 1, 3 at most dentin caries primary teeth without infection, mobility, Angle class I profile and molar relation

  • Willing to participate the study

Exclusion Criteria:
  • History of diagnosed systemic illness

  • Anterior/ posterior crossbite

  • Presence of dental pain

  • Root resorption exceeding 2/3's of the treated tooth

  • Gingival inflammation, periodontal disease

  • Signs of parafunctionism, bruxism

  • Facial asymmetry

  • Signs or symptoms of temporomandibular disfunction

  • Not willing to participate

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bezmialem Vakif University Faculty of Dentistry Department of Pediatric Dentistry Istanbul Turkey
2 Bezmialem Vakif University Faculty of Dentistry Department of Pediatric Dentistry Istanbul Turkey

Sponsors and Collaborators

  • Bezmialem Vakif University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Mustafa Sarp Kaya, Specialist, Bezmialem Vakif University
ClinicalTrials.gov Identifier:
NCT03010618
Other Study ID Numbers:
  • 6.2016/45
First Posted:
Jan 5, 2017
Last Update Posted:
Jul 19, 2017
Last Verified:
Jul 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mustafa Sarp Kaya, Specialist, Bezmialem Vakif University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 19, 2017