Evaluation of Hall Technique and Atraumatic Restorative Treatment for Management of Caries in the Primary Dentition

NCT04367649 | Completed

• 1 other identifier: Hall technique for management
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Dental Caries

Outcome Measures

Primary Outcomes (14)

• Success of the crown (for Hall and conventional techniques)

  The presence of a satisfactory crown will be checked. Loss of the crown, perforated crown or restoration fracture are considered failures.

  1 week

• Success of the crown (for Hall and conventional techniques)

  The presence of a satisfactory crown will be checked. Loss of the crown, perforated crown or restoration fracture are considered failures.

  1 month

• Success of the crown (for Hall and conventional techniques)

  The presence of a satisfactory crown will be checked. Loss of the crown, perforated crown or restoration fracture are considered failures.

  6 months

• Success of the crown (for Hall and conventional techniques)

  The presence of a satisfactory crown will be checked. Loss of the crown, perforated crown or restoration fracture are considered failures.

  12 months

• Success of the atraumatic restorative technique

  Scoring of the restoration between 0-9. 0: Present, satisfactory. 1: Present, slight deficiency at cavity margin of less than 0.5 mm. 2: Present, slight deficiency at cavity margin of 0.5 mm or more. 3: Present, fracture in restoration. 4: Present, fracture in tooth. 5: Present, overextension of approximal margin of 0.5 mm or more. 6: Not present, most or all of restoration missing. 7: Not present, other restorative treatment performed. 8: Not present, tooth is not present. 9: Unable to diagnose. Success scores are 0 and 1, while failure scores are 2-8.

  1 week

• Success of the atraumatic restorative technique

  Scoring of the restoration between 0-9. 0: Present, satisfactory. 1: Present, slight deficiency at cavity margin of less than 0.5 mm. 2: Present, slight deficiency at cavity margin of 0.5 mm or more. 3: Present, fracture in restoration. 4: Present, fracture in tooth. 5: Present, overextension of approximal margin of 0.5 mm or more. 6: Not present, most or all of restoration missing. 7: Not present, other restorative treatment performed. 8: Not present, tooth is not present. 9: Unable to diagnose. Success scores are 0 and 1, while failure scores are 2-8.

  1 month

• Success of the atraumatic restorative technique

  Scoring of the restoration between 0-9. 0: Present, satisfactory. 1: Present, slight deficiency at cavity margin of less than 0.5 mm. 2: Present, slight deficiency at cavity margin of 0.5 mm or more. 3: Present, fracture in restoration. 4: Present, fracture in tooth. 5: Present, overextension of approximal margin of 0.5 mm or more. 6: Not present, most or all of restoration missing. 7: Not present, other restorative treatment performed. 8: Not present, tooth is not present. 9: Unable to diagnose. Success scores are 0 and 1, while failure scores are 2-8.

  6 months

• Success of the atraumatic restorative technique

  Scoring of the restoration between 0-9. 0: Present, satisfactory. 1: Present, slight deficiency at cavity margin of less than 0.5 mm. 2: Present, slight deficiency at cavity margin of 0.5 mm or more. 3: Present, fracture in restoration. 4: Present, fracture in tooth. 5: Present, overextension of approximal margin of 0.5 mm or more. 6: Not present, most or all of restoration missing. 7: Not present, other restorative treatment performed. 8: Not present, tooth is not present. 9: Unable to diagnose. Success scores are 0 and 1, while failure scores are 2-8.

  12 months

• Treatment (restoration) survival

  ART restorations, Hall technique and conventional restorations will be scored as satisfactory will be considered "successful," while those presented minor and/or major failures will be considered as "failed."

  1 week

• Treatment (restoration) survival

  ART restorations, Hall technique and conventional restorations will be scored as satisfactory will be considered "successful," while those presented minor and/or major failures will be considered as "failed."

  1 month

• Treatment (restoration) survival

  ART restorations, Hall technique and conventional restorations will be scored as satisfactory will be considered "successful," while those presented minor and/or major failures will be considered as "failed."

  6 months

• Treatment (restoration) survival

  ART restorations, Hall technique and conventional restorations will be scored as satisfactory will be considered "successful," while those presented minor and/or major failures will be considered as "failed."

  12 months

• Radiographic evaluation of the treatment

  Digital postoperative periapical radiographs will be obtained using a paralleling device to allow for exact and reproducible alignment of the dental film and the X-ray tube at the different follow up intervals. Teeth will be considered radiographically successful if they showed no evidence of radicular radiolucency, internal or external root resorption or periodontal ligament space widening

  6 months

• Radiographic evaluation of the treatment

  Digital postoperative periapical radiographs will be obtained using a paralleling device to allow for exact and reproducible alignment of the dental film and the X-ray tube at the different follow up intervals. Teeth will be considered radiographically successful if they showed no evidence of radicular radiolucency, internal or external root resorption or periodontal ligament space widening

  12 months

Secondary Outcomes (9)

• Child satisfaction

  immediately after completion of the dental treatment procedures

• Assessment of oral cleanliness (plaque)

  1 week

• Assessment of oral cleanliness (plaque)

  1 month

• Assessment of oral cleanliness (plaque)

  6 months

• Assessment of oral cleanliness (plaque)

  12 months

Study Arms (3)

Hall technique

EXPERIMENTAL

Other: Hall technique

Atraumatic restorative treatment

ACTIVE COMPARATOR

Other: Atraumatic restorative treatment

Conventional restorative treatment

SHAM COMPARATOR

Other: Conventional restorative treatment

Interventions

Hall technique OTHER

* 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

Hall technique

Atraumatic restorative treatment OTHER

Caries removal using excavators, then restoration using glass ionomer (GIC)

Atraumatic restorative treatment

Conventional restorative treatment OTHER

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

Conventional restorative treatment

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Nourhan M.Aly: lead
• Alexandria University: collaborator

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, 21512, Egypt

Location

Related Publications (11)

• 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.

  PMID: 25216660 BACKGROUND

• 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.

  PMID: 22027459 BACKGROUND

• 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: 16703041 BACKGROUND

• 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.

  PMID: 24602167 BACKGROUND

• 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.

  PMID: 24402057 BACKGROUND

• 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.

  PMID: 26494348 BACKGROUND

• 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: 18096042 BACKGROUND

• 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.

  PMID: 19927456 BACKGROUND

• 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.

  PMID: 20932395 BACKGROUND

• 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.

  PMID: 8915958 BACKGROUND

• 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.

  PMID: 20372951 BACKGROUND

MeSH Terms

Interventions

Dental Atraumatic Restorative Treatment

Intervention Hierarchy (Ancestors)

Dentistry

Study Officials

• Dina Sharaf, M.Sc

  Faculty of Dentistry, Alexandria University, Egypt

  PRINCIPAL INVESTIGATOR

• Karin ML Dowidar, PhD

  Faculty of Dentistry, Alexandria University, Egypt

  STUDY CHAIR

• Laila M El Habashy, PhD

  Faculty of Dentistry, Alexandria University, Egypt

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dental Public Health clinical instructor and statistician

Study Record Dates

• First Submitted: April 25, 2020
• First Posted: April 29, 2020
• Study Start: November 20, 2018
• Primary Completion: November 29, 2019
• Study Completion: August 30, 2020
• Last Updated: November 4, 2020

Record last verified: 2020-11

Locations

EG (1)