Clinical and Radiographic Comparison of SMART Hall and Conventional Hall Techniques in Children With Carious Primary Molars

NCT07792551 | Not Yet Recruiting

• 1 other identifier: SMART Hall
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Brief Summary Dental caries is one of the most common chronic diseases affecting children, particularly in primary molars, and may lead to pain, impaired function, reduced quality of life, and an increased risk of caries in permanent teeth. Managing caries in young children can be challenging because of behavioral and developmental factors, highlighting the need for minimally invasive, child-friendly treatment approaches. The Hall Technique is an effective minimally invasive approach that uses stainless steel crowns to seal carious primary molars without caries removal, tooth preparation, or local anesthesia. It has demonstrated high clinical success and good patient acceptance. However, concerns remain regarding the activity of residual bacteria within deeper carious lesions. The Silver-Modified Atraumatic Restorative Technique (SMART) incorporates silver diamine fluoride (SDF), which has antibacterial and remineralizing properties, before restoration and sealing. This may provide additional caries-arresting and antibacterial benefits compared with the conventional Hall Technique. Although both techniques have shown promising clinical outcomes, there is limited evidence directly comparing the SMART Hall technique with the conventional Hall Technique, particularly regarding long-term clinical and radiographic outcomes. Therefore, the proposed study aims to evaluate whether adding SDF to the Hall Technique improves treatment success in carious primary molars. The findings may help identify an effective, minimally invasive, and child-friendly approach for managing dental caries in pediatric patients.

Conditions

Clinical Effect

Keywords

SMART HALL; Conventional Hall Technique; SDF; Children

Outcome Measures

Primary Outcomes (1)

• Clinical evaluation

  1. Presence of pain on percussion: Measuring device: Clinical examination. Measuring unit: Binary (If present: Yes , if absent: NO) 2. Presence of swelling: Measuring device: Clinical examination. Measuring unit: Binary (If present: Yes , if absent: NO) 3. Presence of fistula: Measuring device: Clinical examination. Measuring unit: Binary (If present: Yes , if absent: NO) 4. Presence of mobility: Measuring device: Clinical examination by the back of the mirror and asking the patient if there is pain on percussion. Measuring unit: (If present: Yes , if absent: NO)

  12 months

Secondary Outcomes (1)

• Radiographic Evaluation

  12 months

Study Arms (2)

SMART Hall Technique, SDF before Conventional Hall Technique.

EXPERIMENTAL

SDF is applied before the Conventional Hall technique to arrest the bacterial action.

Other: SDF with stainless steel crown

Conventional Hall Technique

ACTIVE COMPARATOR

Hall technique will be applied using glass ionomer cement under the stainless steel crown without SDF.

Other: Conventional Hall Technique

Interventions

SDF with stainless steel crown OTHER

Will apply SDF before applying the stainless steel crown with glass ionomer cement without caries removal or local anesthesia.

SMART Hall Technique, SDF before Conventional Hall Technique.

Conventional Hall Technique OTHER

Applying stainless steel crown with glass ionomer cement without SDF and no need for preparation or caries removal or local anesthesia.

Conventional Hall Technique

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 4 to 8 years old.
• One surface carious lesion.
• No signs and symptoms. (e.g., no tooth pain)
• Presence of one or more primary molar(s) with deep carious dentine.
• Tooth-related eligibility criteria:
• Presence of active cavitated carious lesions that can be removed by an excavator are accessible with hand instruments.
• Vital pulp with symptom-free or reversible pulpitis.
• No spontaneous/prolonged pain or percussion pain.
• No abnormal mobility or signs of infection (swelling, fistula, abscess).
• Sufficient tooth structure for stainless steel crown retention.
• Deep caries lesions radiographically extend through at least the inner half of the dentine.
• Presence of a clear band of normal-appearing dentine between the carious lesion and the pulp in a bitewing radiograph.
• More than 2/3 of the roots remaining.
• No internal/external resorption or periapical/furcation pathology.

You may not qualify if:

• \. Presence of severe systemic medical conditions (e.g., uncontrolled diabetes, immunodeficiency disorders).
• \. Use of medications known to interfere with dental treatment or healing, such as anticoagulants or immunosuppressants.
• \. Presence of extensive dental caries or additional oral pathologies requiring urgent or specialized dental care beyond the scope of the study.
• \. Patients allergic/sensitive to nickel since PMCs contain nickel. 5. Cases with significant space loss or reduced mesio-distal width due to interproximal caries (making crown fitting difficult).
• \. Unaffected dentine between lesion and pulp cannot be confirmed clinically/radiographically.
• \. Presence of extensive dental caries or additional oral pathology requiring urgent or specified dental care beyond scope of study.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry, Cairo University, Cairo, Egypt.

Cairo, Cairo Governorate, 11511, Egypt

Location

Related Publications (14)

• Altoukhi DH, El-Housseiny AA. Hall Technique for Carious Primary Molars: A Review of the Literature. Dent J (Basel). 2020 Jan 17;8(1):11. doi: 10.3390/dj8010011.

  PMID: 31963463 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

• Santamaria RM, Gomma A, Khole MR, Splieth CH, Alkilzy M. Influence of the Hall Technique on Patient Cooperation: A Retrospective Analysis. J Clin Med. 2025 Jan 7;14(2):304. doi: 10.3390/jcm14020304.

  PMID: 39860309 BACKGROUND

• Alshahrani A, Alamro H, Alanazi F, Alowaidi L, Alhamdan F. Assessment of Knowledge, Attitude, and Teaching of the Hall Technique Among Pediatric Dentistry Faculty in Riyadh, Saudi Arabia. Dent J (Basel). 2025 May 28;13(6):239. doi: 10.3390/dj13060239.

  PMID: 40559142 BACKGROUND

• Mittal M, Chopra R, Kumar A, Kaur IP. Combination of Silver Diamine Fluoride and Hall Technique for Caries Management in Primary Molars: A Randomized Controlled Trial. Int J Clin Pediatr Dent. 2024 Oct;17(10):1114-1120. doi: 10.5005/jp-journals-10005-2980.

  PMID: 39650295 BACKGROUND

• Bhatia HP, Khari PM, Sood S, Sharma N, Singh A. Evaluation of Clinical Effectiveness and Patient Acceptance of Hall Technique for Managing Carious Primary Molars: An In Vivo Study. Int J Clin Pediatr Dent. 2019 Nov-Dec;12(6):548-552. doi: 10.5005/jp-journals-10005-1699.

  PMID: 32440073 BACKGROUND

• Min SN, Duangthip D, Phyo WM, Somboonsavatdee A, Samaranayake L, Detsomboonrat P. A Clinical Trial of 38% Silver Diamine Fluoride With Light Curing in Arresting Dentine Caries in Primary Teeth. Int Dent J. 2025 Jun;75(3):2084-2092. doi: 10.1016/j.identj.2024.12.030. Epub 2025 Jan 30.

  PMID: 39884902 BACKGROUND

• Youssef, L. Y. W., & El Shahawy, O. A. (2025). Digital occlusal analysis and bite force evaluation of Hall technique vs stainless-steel crowns as conventional restoration of carious primary molars using T-scan: A randomized clinical trial (ClinicalTrials.gov Identifier NCT07295574). ClinicalTrials.gov. https://clinicaltrials.gov/study/NCT07295574

  BACKGROUND

• TGP Team. Stainless steel crowns in pediatric dentistry: A complete guide [Internet]. Trinity Group Purchasing; 2026 Feb [cited 2026 Jun 23]. Available from: https://tgpo.io/guides/stainless-steel-crowns-pediatric-guide

  BACKGROUND

• Sharaf, D. A., Dowidar, K., El Habashy, L. M., & Hamed, H. (2021). Hall technique versus the conventional stainless-steel crowns restoring carious primary molar teeth: A randomized controlled clinical trial. Alexandria Dental Journal, 46(3), 174-180. https://adjalexu.journals.ekb.eg/article_206251_9b36dc4aa9ed7d6c9dd0bb44ca3bf387.pdf

  BACKGROUND

• Paranjape, M. N., & Shah, P. P. (2023). Smart Hall's technique: An innovative and minimally invasive novel option for managing carious primary molars-A case report. Asian Pacific Journal of Health Sciences, 10(2), 40-42.

  BACKGROUND

• Kezawie, A., Almonaqel, M.B., Katbeh, I., Kosyreva, T., Alawwad, M., Khasan, A. et al., 2021. A comparison between Hall's technique and the conventional method of managing proximal caries in primary teeth. International Journal of Dentistry and Oral Science, 8(1), pp.1329-1336. https://doi.org/10.19070/2377-8075-21000263

  BACKGROUND

• Katika, S. B. P. (2025). Comparative evaluation of SMART Hall technique vs. conventional SS crown in primary molars: A randomized clinical trial (RCT) (ClinicalTrials.gov Identifier NCT06453005). ClinicalTrials.gov. https://clinicaltrials.gov/study/NCT06453005

  BACKGROUND

• Ayedun OS, Oredugba FA, Sote EO. Comparison of the treatment outcomes of the conventional stainless steel crown restorations and the hall technique in the treatment of carious primary molars. Niger J Clin Pract. 2021 Apr;24(4):584-594. doi: 10.4103/njcp.njcp_460_20.

  PMID: 33851682 BACKGROUND

Related Links

• Related Info

Study Officials

• Rania Abdallah Nasr Nasr

  Professor of Pediatric Dentistry, Faculty of Dentistry, Cairo University.

  STUDY DIRECTOR

• Norhan Omar Ahmad El-Gebaly El-Gebaly

  Lecturer of Pediatric Dentistry and Public Health.

  STUDY DIRECTOR

Central Study Contacts

Rana Amr Abd El-Tawab Shafik A Shafik

CONTACT

+02 01124702071; ramr04320@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Dentist.

Model Details: Will apply SDF before Conventional Hall Technique.

Study Record Dates

• First Submitted: August 21, 2026
• First Posted: August 28, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: August 28, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 12 months

Locations

EG (1)