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

Primary Purpose

Caries, Dental

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Hall technique stainless steel crowns
Sponsored by
Bezmialem Vakif University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Caries, Dental focused on measuring hall technique, stainless steel crowns, temporomandibular joint, dental caries, occlusion

Eligibility Criteria

5 Years - 8 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Bezmialem Vakif University Faculty of Dentistry Department of Pediatric DentistryRecruiting
  • Bezmialem Vakif University Faculty of Dentistry Department of Pediatric DentistryRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Study Group

Arm Description

Outcomes

Primary Outcome Measures

Complete canine overbite return
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.

Secondary Outcome Measures

Full Information

First Posted
December 31, 2016
Last Updated
July 16, 2017
Sponsor
Bezmialem Vakif University
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1. Study Identification

Unique Protocol Identification Number
NCT03010618
Brief Title
The Effects of Stainless Steel Crowns Applied With Hall Technique on Occlusal Vertical Dimension
Official Title
Hall Teknik Ile Uygulanan Paslanmaz Celik kronların Okluzal Dikey Boyuta Etkilerinin değerlendirilmesi
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 24, 2017 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bezmialem Vakif University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caries, Dental
Keywords
hall technique, stainless steel crowns, temporomandibular joint, dental caries, occlusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
125 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study Group
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Hall technique stainless steel crowns
Intervention Description
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 Measure Information:
Title
Complete canine overbite return
Description
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.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Bezmialem Vakif University Faculty of Dentistry Department of Pediatric Dentistry
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarp Kaya, DDS,PhD, Pediatric Dentist
Phone
0212 453 17 00
Email
dtsarpkaya@hotmail.com
First Name & Middle Initial & Last Name & Degree
Pınar Kınay Taran, DDS, Pediatric Dentist
First Name & Middle Initial & Last Name & Degree
Sarp Kaya, DDS,PhD, Pediatric Dentist
First Name & Middle Initial & Last Name & Degree
Meltem Bakkal, DDS,PhD, Pediatric Dentist
Facility Name
Bezmialem Vakif University Faculty of Dentistry Department of Pediatric Dentistry
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarp Kaya, DDS,PhD, Pediatric Dentist
Phone
00902124531700
Email
dtsarpkaya@hotmail.com
First Name & Middle Initial & Last Name & Degree
Sarp Kaya, DDS,PhD, Pediatric Dentist
First Name & Middle Initial & Last Name & Degree
Pınar Kınay Taran, DDS, Pediatric Dentist
First Name & Middle Initial & Last Name & Degree
Meltem Bakkal, DDS,PhD, Pediatric Dentist

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
18096042
Citation
Innes NP, Evans DJ, Stirrups DR. The Hall Technique; a randomized controlled clinical trial of a novel method of managing carious primary molars in general dental practice: acceptability of the technique and outcomes at 23 months. BMC Oral Health. 2007 Dec 20;7:18. doi: 10.1186/1472-6831-7-18.
Results Reference
background
PubMed Identifier
16703041
Citation
Innes NP, Stirrups DR, Evans DJ, Hall N, Leggate M. A novel technique using preformed metal crowns for managing carious primary molars in general practice - a retrospective analysis. Br Dent J. 2006 Apr 22;200(8):451-4; discussion 444. doi: 10.1038/sj.bdj.4813466.
Results Reference
background
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
background
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
24913609
Citation
Gallagher S, O'Connell BC, O'Connell AC. Assessment of occlusion after placement of stainless steel crowns in children - a pilot study. J Oral Rehabil. 2014 Oct;41(10):730-6. doi: 10.1111/joor.12196. Epub 2014 Jun 10.
Results Reference
result

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

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