Clinical trial NCT04367649: Evaluation of Hall Technique and Atraumatic Restorative Treatment for Management of Caries in the Primary Dentition
Official title: Evaluation of Hall Technique and Atraumatic Restorative Treatment for Management of Caries in the Primary Dentition (A Randomized Controlled Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Dental Caries
Lead sponsor: University of Alexandria
Sponsor class: OTHER
Collaborators: name: Alexandria University
First posted: 2020-04-29
Enrollment: 155
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the present study is to evaluate both Hall technique and atraumatic restorative technique in comparison to the conventional restorative technique in the management of carious lesions in primary molars.

Detailed description: This study is a three arm randomized controlled clinical trial. Eligible children will be selected from the outpatient clinic of Pediatric Dentistry and Public Health Department, Faculty of Dentistry, Alexandria University after securing necessary consents. One hundred and fifty five teeth will be randomly allocated into 3 groups fifty two each. Group I will be assigned to Hall technique Group II will be assigned to atraumatic restorative treatment using Glass ionomer cement, and Group III will be assigned to a conventional restoration and will serve as a control.

Eligibility criteria: Inclusion Criteria:

* Children free of any systemic disease or special health care needs.
* Cooperative children ( positive/ definitely positive) according to Frankl's behavior rating scale.
* Children who are willing to participate in the study
* Tooth inclusion criteria:

  * 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:

* Clinical signs and symptoms of irreversible pulpilitis.
* Tooth mobility
* Spontaneous pain

Primary outcomes:
measure: Success of the crown (for Hall and conventional techniques)
timeFrame: 1 week
measure: Success of the crown (for Hall and conventional techniques)
timeFrame: 1 month
measure: Success of the crown (for Hall and conventional techniques)
timeFrame: 6 months
measure: Success of the crown (for Hall and conventional techniques)
timeFrame: 12 months
measure: Success of the atraumatic restorative technique
timeFrame: 1 week
measure: Success of the atraumatic restorative technique
timeFrame: 1 month
measure: Success of the atraumatic restorative technique
timeFrame: 6 months
measure: Success of the atraumatic restorative technique
timeFrame: 12 months
measure: Treatment (restoration) survival
timeFrame: 1 week
measure: Treatment (restoration) survival
timeFrame: 1 month
measure: Treatment (restoration) survival
timeFrame: 6 months
measure: Treatment (restoration) survival
timeFrame: 12 months
measure: Radiographic evaluation of the treatment
timeFrame: 6 months
measure: Radiographic evaluation of the treatment
timeFrame: 12 months
Secondary outcomes:
measure: Child satisfaction
timeFrame: immediately after completion of the dental treatment procedures
measure: Assessment of oral cleanliness (plaque)
timeFrame: 1 week
measure: Assessment of oral cleanliness (plaque)
timeFrame: 1 month
measure: Assessment of oral cleanliness (plaque)
timeFrame: 6 months
measure: Assessment of oral cleanliness (plaque)
timeFrame: 12 months
measure: Assessment of the gingival condition
timeFrame: 1 week
measure: Assessment of the gingival condition
timeFrame: 1 month
measure: Assessment of the gingival condition
timeFrame: 6 months
measure: Assessment of the gingival condition
timeFrame: 12 months
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Dina Sharaf, M.Sc
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Karin ML Dowidar, PhD
role: STUDY_CHAIR
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Laila M El Habashy, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
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.
citation: 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.
citation: 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.
citation: 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.
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.
citation: 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.
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.
citation: 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.
citation: 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.