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Trial record 47 of 83 for:    tooth decay | Recruiting Studies

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

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ClinicalTrials.gov Identifier: NCT03010618
Recruitment Status : Recruiting
First Posted : January 5, 2017
Last Update Posted : July 19, 2017
Sponsor:
Information provided by (Responsible Party):
Mustafa Sarp Kaya, Bezmialem Vakif University

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
Caries, Dental Other: Hall technique stainless steel crowns Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 125 participants
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 : January 24, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Complete canine overbite return [ Time Frame: 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.



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Ages Eligible for Study:   5 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03010618


Locations
Turkey
Bezmialem Vakif University Faculty of Dentistry Department of Pediatric Dentistry Recruiting
Istanbul, Turkey
Contact: Sarp Kaya, DDS,PhD, Pediatric Dentist    0212 453 17 00    dtsarpkaya@hotmail.com   
Principal Investigator: Pınar Kınay Taran, DDS, Pediatric Dentist         
Principal Investigator: Sarp Kaya, DDS,PhD, Pediatric Dentist         
Principal Investigator: Meltem Bakkal, DDS,PhD, Pediatric Dentist         
Bezmialem Vakif University Faculty of Dentistry Department of Pediatric Dentistry Recruiting
Istanbul, Turkey
Contact: Sarp Kaya, DDS,PhD, Pediatric Dentist    00902124531700    dtsarpkaya@hotmail.com   
Principal Investigator: Sarp Kaya, DDS,PhD, Pediatric Dentist         
Principal Investigator: Pınar Kınay Taran, DDS, Pediatric Dentist         
Principal Investigator: Meltem Bakkal, DDS,PhD, Pediatric Dentist         
Sponsors and Collaborators
Bezmialem Vakif University

Publications of Results:
Other Publications:
Responsible Party: Mustafa Sarp Kaya, Specialist, Bezmialem Vakif University
ClinicalTrials.gov Identifier: NCT03010618     History of Changes
Other Study ID Numbers: 6.2016/45
First Posted: January 5, 2017    Key Record Dates
Last Update Posted: July 19, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
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, Bezmialem Vakif University:
hall technique
stainless steel crowns
temporomandibular joint
dental caries
occlusion

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases