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

Hall Teknik Ile Uygulanan Paslanmaz Celik kronların Okluzal Dikey Boyuta Etkilerinin değerlendirilmesi

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.

Study Overview

• Status: Unknown
• Conditions: Caries, Dental
• Intervention / Treatment: Other: Hall technique stainless steel crowns

• Study Type: Interventional
• Enrollment (Anticipated): 125
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Recruiting
    • Bezmialem Vakif University Faculty of Dentistry Department of Pediatric Dentistry
    • Principal Investigator: Pınar Kınay Taran, DDS, Pediatric Dentist
    • Principal Investigator: Sarp Kaya, DDS,PhD, Pediatric Dentist
    • Principal Investigator: Meltem Bakkal, DDS,PhD, Pediatric Dentist
    • Contact: Sarp Kaya, DDS,PhD, Pediatric Dentist; Phone Number: 00902124531700; Email: dtsarpkaya@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 days

Collaborators and Investigators

• Sponsor: Bezmialem Vakif University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2017
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: December 31, 2016
• First Submitted That Met QC Criteria: January 4, 2017
• First Posted (Estimate): January 5, 2017

Study Record Updates

• Last Update Posted (Actual): July 19, 2017
• Last Update Submitted That Met QC Criteria: July 16, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: occlusion; dental caries; temporomandibular joint; hall technique; stainless steel crowns
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: 6.2016/45

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No