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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03010618
Other study ID # 6.2016/45
Secondary ID
Status Recruiting
Phase N/A
First received December 31, 2016
Last updated July 16, 2017
Start date January 24, 2017
Est. completion date December 2019

Study information

Verified date July 2017
Source Bezmialem Vakif University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 125
Est. completion date December 2019
Est. primary completion date December 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 5 Years to 8 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Turkey Bezmialem Vakif University Faculty of Dentistry Department of Pediatric Dentistry Istanbul
Turkey Bezmialem Vakif University Faculty of Dentistry Department of Pediatric Dentistry Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

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. — View 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. — View 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. — View 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. Review. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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