Hall Technique or Modified Hall Technique of Deep Carious Lesions in Primary Molars

NCT05220865 | Completed

• 1 other identifier: E2-21-956
• Study Type: interventional
• Target: 268
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this randomized clinical trial is to compare the clinical/radiographic success of Hall technique and modified Hall technique in the treatment of primary molars with deep dentine carious lesions in children (3-12-year-old). The secondary aim is to examine the effect of marginal ridge breakdown level on treatment success.

Conditions

Dental Caries in Children; Tooth Diseases; Tooth Demineralization; Stomatognathic Diseases

Keywords

Hall Technique; Deep dentine caries; Carious primary molars

Outcome Measures

Primary Outcomes (1)

• Clinical and radiographic success of the treatments

  The clinical evaluation will be performed by one blinded examiner with the criteria as proposed by Innes et al. (2007). Outcome criteria for the clinical and radiographic assessment of restorations and teeth will be as follows: Treatments will be considered as "successful" if the restoration appears satisfactory (no intervention required), no clinical signs or symptoms of pulpal pathology, no pathology visible on radiographs or tooth exfoliated The treatments will be classified as "minor failure" if there is a crown perforation, new caries around margins, restoration loss (tooth restorable) and/or reversible pulpitis treated without requiring pulpotomy or extraction. The treatments will be classified as "major failure" if there is irreversible pulpitis or dental abscess requiring pulpotomy or extraction, inter-radicular radiolucency, restoration loss (tooth unrestorable) and/or internal root resorption (Innes et al., 2007).

  Change from baseline up to 3, 6 and 12 months

Secondary Outcomes (1)

• The effect of the amount of marginal ridge fracture on treatment success

  Change from baseline up to 3, 6 and 12 months

Study Arms (2)

Hall Technique

ACTIVE COMPARATOR

A preformed metal crown will be cemented on the carious primary molar tooth without any tooth preparation and local anesthesia.

Procedure: Hall Technique

Modified Hall Technique

EXPERIMENTAL

In the Modified Hall technique only infected soft dentin tissue will be removed with hand instruments and a preformed metal crown will be placed with Hall technique.

Procedure: Modified Hall Technique

Interventions

Hall Technique PROCEDURE

* Only food scraps or debris will be removed from the caries cavity. * The smallest crown size will be selected that covers all cusps and approaches the contact points with a slight "springback" feel. * If the contact points are tight, orthodontic elastic separators will be placed through the contacts and the SSC will be placed at the second appointment 3-5 days later. * The SSC will be loaded with glass ionomer luting cement and placed evenly on the tooth. * The child will be asked to bite firmly until the crown is pushed down over the tooth. * If the child is unable or unwilling to bite down on the SSC, finger pressure will be used to seat the crown * The child will continue to bite on a cotton roll until the cement hardens * Excess glass ionomer cement will be removed from the crown margins with hand instruments and dental floss.

Hall Technique

Modified Hall Technique PROCEDURE

* Food scraps or debris will be cleaned from the caries cavity and infected soft carious dentin tissue will be excavated with hand instruments. * The smallest crown size will be selected that covers all cusps and approaches the contact points with a slight "springback" feel. * If the contact points are tight, orthodontic elastic separators will be placed through the contacts and the SSC will be placed at the second appointment 3-5 days later. * The SSC will be loaded with glass ionomer luting cement and placed evenly on the tooth. * The child will be asked to bite firmly until the crown is pushed down over the tooth. * If the child is unable or unwilling to bite down on the SSC, finger pressure will be used to seat the crown * The child will continue to bite on a cotton roll until the cement hardens * Excess glass ionomer cement will be removed from the crown margins with hand instruments and dental floss.

Modified Hall Technique

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Medically healthy children
• Participants attending follow-up appointments
• Children having at least one primary molar tooth with deep dentin caries involving occluso proximal surfaces.
• Vital pulp with symptom-free or reversible pulpitis
• Presence of marginal ridge breakdown and accessible cavity with hand instruments,
• Presence of active cavitated carious lesion (Code 3 with Nyvad criteria for caries lesion activity and severity assessment- Nyvad et al., 1999)
• Absence of spontaneous or prolonged pain related with irreversible pulpitis
• Absence of fistula or abscess near the tooth
• Absence of pathological mobility
• Absence of pain on percussion
• Absence of pulp exposure
• Caries lesion located in ½ inner part of dentin radiographically
• Presence of sound dentin layer between the deepest part of the carious lesion and the pulp radiographically
• Absence of periapical or furcation pathologies on radiographs
• Absence of internal and external root resorption on radiographs

You may not qualify if:

• Any systemic disease, physical or mental disorder
• Children or parents who doesn't accept to participate and sign the informed consent
• Clinical or radiographic signs of pulpal or peri-radicular pathology
• Caries cavity which cannot be accessible to hand instruments
• Physiological root resorption more than 1/2 of the root in primary molars

Sponsors & Collaborators

• Ankara Yildirim Beyazıt University: lead

Study Sites (1)

Ankara Yıldırım Beyazıt University Faculty of Dentistry

Ankara, Turkey (Türkiye)

Location

Related Publications (8)

• Boyd DH, Thomson WM, Leon de la Barra S, Fuge KN, van den Heever R, Butler BM, Leov F, Foster Page LA. A Primary Care Randomized Controlled Trial of Hall and Conventional Restorative Techniques. JDR Clin Trans Res. 2021 Apr;6(2):205-212. doi: 10.1177/2380084420933154. Epub 2020 Jun 19.

  PMID: 32559403 BACKGROUND

• Boyd DH, Page LF, Thomson WM. The Hall Technique and conventional restorative treatment in New Zealand children's primary oral health care - clinical outcomes at two years. Int J Paediatr Dent. 2018 Mar;28(2):180-188. doi: 10.1111/ipd.12324. Epub 2017 Aug 8.

  PMID: 28787534 BACKGROUND

• Eden E, Frencken J, Gao S, Horst JA, Innes N. Managing dental caries against the backdrop of COVID-19: approaches to reduce aerosol generation. Br Dent J. 2020 Oct;229(7):411-416. doi: 10.1038/s41415-020-2153-y. Epub 2020 Oct 9.

  PMID: 33037360 BACKGROUND

• GBD 2017 Oral Disorders Collaborators; Bernabe E, Marcenes W, Hernandez CR, Bailey J, Abreu LG, Alipour V, Amini S, Arabloo J, Arefi Z, Arora A, Ayanore MA, Barnighausen TW, Bijani A, Cho DY, Chu DT, Crowe CS, Demoz GT, Demsie DG, Dibaji Forooshani ZS, Du M, El Tantawi M, Fischer F, Folayan MO, Futran ND, Geramo YCD, Haj-Mirzaian A, Hariyani N, Hasanzadeh A, Hassanipour S, Hay SI, Hole MK, Hostiuc S, Ilic MD, James SL, Kalhor R, Kemmer L, Keramati M, Khader YS, Kisa S, Kisa A, Koyanagi A, Lalloo R, Le Nguyen Q, London SD, Manohar ND, Massenburg BB, Mathur MR, Meles HG, Mestrovic T, Mohammadian-Hafshejani A, Mohammadpourhodki R, Mokdad AH, Morrison SD, Nazari J, Nguyen TH, Nguyen CT, Nixon MR, Olagunju TO, Pakshir K, Pathak M, Rabiee N, Rafiei A, Ramezanzadeh K, Rios-Blancas MJ, Roro EM, Sabour S, Samy AM, Sawhney M, Schwendicke F, Shaahmadi F, Shaikh MA, Stein C, Tovani-Palone MR, Tran BX, Unnikrishnan B, Vu GT, Vukovic A, Warouw TSS, Zaidi Z, Zhang ZJ, Kassebaum NJ. Global, Regional, and National Levels and Trends in Burden of Oral Conditions from 1990 to 2017: A Systematic Analysis for the Global Burden of Disease 2017 Study. J Dent Res. 2020 Apr;99(4):362-373. doi: 10.1177/0022034520908533. Epub 2020 Mar 2.

  PMID: 32122215 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

• 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

• Nyvad B, Baelum V. Nyvad Criteria for Caries Lesion Activity and Severity Assessment: A Validated Approach for Clinical Management and Research. Caries Res. 2018;52(5):397-405. doi: 10.1159/000480522. Epub 2018 Mar 5.

  PMID: 29506010 BACKGROUND

• Konukman Turker S, Cihan AI. Two-year outcomes of hall technique and modified hall technique in deep carious lesions of primary molars: a randomized clinical trial. BMC Oral Health. 2026 Jan 12. doi: 10.1186/s12903-026-07667-2. Online ahead of print.

  PMID: 41526924 DERIVED

Related Links

• Cho V, Anthonappa R, King N." Marginal Ridge Breakdown as a Predictor for Pulpal Involvement in Primary Molar". The International Association of Pediatric Dentistry. Global Summit on Early Childhood Caries.

MeSH Terms

Conditions

Tooth Diseases; Tooth Demineralization; Stomatognathic Diseases

Study Officials

• Ayşe I. Orhan, Assoc. Prof.

  Ankara Yıldırım Beyazit University Faculty of Dentistry

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participant, investigator evaluating treatment success at follow-up appointments and biostatistician will be blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 22, 2022
• First Posted: February 2, 2022
• Study Start: February 1, 2022
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2025
• Last Updated: October 6, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)