Evaluation of Hall Technique and Atraumatic Restorative Treatment for Management of Caries in the Primary Dentition
NCT ID: NCT04367649
Last Updated: 2020-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
155 participants
INTERVENTIONAL
2018-11-20
2020-08-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Hall technique
Hall technique
* Orthodontic separators will be used to create space for fitting the stainless crown, then removed after 3-5 days
* Occlusion will be measured assessing the patient's occlusal-vertical dimensions (OVD) using a modified version of van der Zee and van Amerongen method with a millimeter probe measuring the distance from the lowest point of the gingiva, around the lower canine on the vestibular side up to the point where the tip of the upper canine ends in order to assess the degree of overbite after mounting of the crown.
* The correct crown size will be selected. The crown should cover all the cusps and approaches the contact points, with a slight feeling of "spring back." till reaching the gingival margin. Cementation will be done using glass ionomer cement
Atraumatic restorative treatment
Atraumatic restorative treatment
Caries removal using excavators, then restoration using glass ionomer (GIC)
Conventional restorative treatment
Conventional restorative treatment
Complete caries removal using high-speed hand piece, and an excavator to clear carious dentin from the pulpal wall. Then, stainless steel crown preparation, selection of the proper size with the smallest crown size that completely covers the preparation chosen. The correct occlusogingival crown length will be established. Cementation will be done using glass ionomer cement
Interventions
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Hall technique
* Orthodontic separators will be used to create space for fitting the stainless crown, then removed after 3-5 days
* Occlusion will be measured assessing the patient's occlusal-vertical dimensions (OVD) using a modified version of van der Zee and van Amerongen method with a millimeter probe measuring the distance from the lowest point of the gingiva, around the lower canine on the vestibular side up to the point where the tip of the upper canine ends in order to assess the degree of overbite after mounting of the crown.
* The correct crown size will be selected. The crown should cover all the cusps and approaches the contact points, with a slight feeling of "spring back." till reaching the gingival margin. Cementation will be done using glass ionomer cement
Atraumatic restorative treatment
Caries removal using excavators, then restoration using glass ionomer (GIC)
Conventional restorative treatment
Complete caries removal using high-speed hand piece, and an excavator to clear carious dentin from the pulpal wall. Then, stainless steel crown preparation, selection of the proper size with the smallest crown size that completely covers the preparation chosen. The correct occlusogingival crown length will be established. Cementation will be done using glass ionomer cement
Eligibility Criteria
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Inclusion Criteria
* Cooperative children ( positive/ definitely positive) according to Frankl's behavior rating scale.
* Children who are willing to participate in the study
* Primary molar teeth with occlusal or occlusoproximal carious lesions into dentin (International Caries Detection and Assessment System) (ICDAS) codes: 3-5
* Absence of clinical signs or symptoms of irreversible pulpitis
* Absence of fistula or abscess near the selected tooth clinically and radiographically
* Absence of spontaneous pain
* Absence of pulp exposure
* Absence of pathological mobility by placing the points of a pair of tweezers in an occlusal fossa, and gently rocking the tooth bucco-lingually.
Exclusion Criteria
* Tooth mobility
* Spontaneous pain
4 Years
8 Years
ALL
No
Sponsors
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Alexandria University
OTHER
Nourhan M.Aly
OTHER
Responsible Party
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Nourhan M.Aly
Dental Public Health clinical instructor and statistician
Principal Investigators
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Dina Sharaf, M.Sc
Role: PRINCIPAL_INVESTIGATOR
Faculty of Dentistry, Alexandria University, Egypt
Karin ML Dowidar, PhD
Role: STUDY_CHAIR
Faculty of Dentistry, Alexandria University, Egypt
Laila M El Habashy, PhD
Role: STUDY_CHAIR
Faculty of Dentistry, Alexandria University, Egypt
Locations
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Faculty of Dentistry, Alexandria University
Alexandria, , Egypt
Countries
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References
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Santamaria RM, Innes NP, Machiulskiene V, Evans DJ, Splieth CH. Caries management strategies for primary molars: 1-yr randomized control trial results. J Dent Res. 2014 Nov;93(11):1062-9. doi: 10.1177/0022034514550717. Epub 2014 Sep 12.
Gruythuysen RJ, van Strijp AJ, van Palestein Helderman WH, Frankenmolen FW. [Non-restorative treatment of cavities in temporary dentition: effective and child-friendly]. Ned Tijdschr Geneeskd. 2011;155(42):A3489. Dutch.
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.
Santamaria RM, Innes NP, Machiulskiene V, Evans DJ, Alkilzy M, Splieth CH. Acceptability of different caries management methods for primary molars in a RCT. Int J Paediatr Dent. 2015 Jan;25(1):9-17. doi: 10.1111/ipd.12097. Epub 2014 Mar 7.
Frencken JE, Holmgren CJ. Caries management through the Atraumatic Restorative Treatment (ART) approach and glass-ionomers: update 2013. Braz Oral Res. 2014;28:5-8. doi: 10.1590/S1806-83242013000600001. No abstract available.
Innes N, Stewart M, Souster G, Evans D. The Hall Technique; retrospective case-note follow-up of 5-year RCT. Br Dent J. 2015 Oct 23;219(8):395-400. doi: 10.1038/sj.bdj.2015.816.
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.
Innes N, Evans D, Hall N. The Hall Technique for managing carious primary molars. Dent Update. 2009 Oct;36(8):472-4, 477-8. doi: 10.12968/denu.2009.36.8.472.
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.
Frencken JE, Pilot T, Songpaisan Y, Phantumvanit P. Atraumatic restorative treatment (ART): rationale, technique, and development. J Public Health Dent. 1996;56(3 Spec No):135-40; discussion 161-3. doi: 10.1111/j.1752-7325.1996.tb02423.x.
Farag A, van der Sanden WJ, Abdelwahab H, Frencken JE. Survival of ART restorations assessed using selected FDI and modified ART restoration criteria. Clin Oral Investig. 2011 Jun;15(3):409-15. doi: 10.1007/s00784-010-0403-0. Epub 2010 Apr 7.
Other Identifiers
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Hall technique for management
Identifier Type: -
Identifier Source: org_study_id