NCT03010618

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
125

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 31, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 5, 2017

Completed
19 days until next milestone

Study Start

First participant enrolled

January 24, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

July 19, 2017

Status Verified

July 1, 2017

Enrollment Period

2.9 years

First QC Date

December 31, 2016

Last Update Submit

July 16, 2017

Conditions

Keywords

hall techniquestainless steel crownstemporomandibular jointdental cariesocclusion

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Study Group

OTHER
Other: Hall technique stainless steel crowns

Interventions

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.

Study Group

Eligibility Criteria

Age5 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Bezmialem Vakif University Faculty of Dentistry Department of Pediatric Dentistry

Istanbul, Turkey (Türkiye)

RECRUITING

Bezmialem Vakif University Faculty of Dentistry Department of Pediatric Dentistry

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (5)

  • 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.

    PMID: 18096042BACKGROUND
  • 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.

    PMID: 16703041BACKGROUND
  • 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.

    PMID: 18808544BACKGROUND
  • 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.

  • 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.

MeSH Terms

Conditions

Dental CariesBites and Stings

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic DiseasesPoisoningChemically-Induced DisordersWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist

Study Record Dates

First Submitted

December 31, 2016

First Posted

January 5, 2017

Study Start

January 24, 2017

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

July 19, 2017

Record last verified: 2017-07

Locations