A Study Comparing the Hall Technique and Conventional Stainless-Steel Crowns in Carious Primary Molars : Clinical Outcomes, Anxiety, Time, and Cost-Effectiveness

NCT07648654 | Recruiting DMC

• 1 other identifier: Minia University 138
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Tooth decay is a widely experienced condition associated with the oral health of children, particularly in posterior teeth. This is attributed to their intricate texture which is commonly encountered during the oral hygiene measures . Caring for posterior teeth affected by tooth decay in children is vital to ensure stability in tooth occlusion, minimizing pain, preventing infections, and facilitating mastication and communication. However, the success of tooth restorations is questionable, particularly due to secondary decay, fracture, loss of retention, and marginal problems. Stainless steel crowns are deemed one of the most durable and reliable treatment options in pediatric dentistry, especially for multi-surface lesions or structurally damaged molars. In a conventional approach to placing SSCs, caries needs to be removed, teeth prepared, and in most cases, local anesthesia is administered. These approaches can be quite time-consuming and may exacerbate dental anxiety in children who report previous negative dental experiences. In the last couple of decades, there has been a gradual move toward minimal invasive dentistry (MID) in caries management. This philosophy emphasizes the importance of maintaining sound tooth structure and adopts biological methods instead of traditional operative methods . This is further consolidated by consensus guidelines that recommend either non- selective or selective caries removal methods for the purpose of minimizing patient discomfort and limiting the invasiveness of treatment. Moreover, practitioners highlight the need for early intervention and the application of less invasive methods where clinically indicated. HT represents a biologically based, minimally invasive approach within the MID framework. This approach involves cementing a preformed metal crown over a carious posterior tooth without local anesthesia, caries excavation, or tooth preparation to seal the lesion from the oral environment. Despite several studies demonstrating favorable results of HT, there is still a lack of well-documented evidence on RCTs comparing clinical and radiographic outcomes, patient anxiety, treatment duration, and cost-effectiveness between HT and conventional SSC placement. The aim of the study, therefore, was to establish whether the Hall Technique, compared to the conventional stainless-steel crown technique, is efficient in managing carious posterior teeth in children aged 5-8 years. Outcomes included crown survival, anxiety levels of the patient, treatment time required, and cost-effectiveness over a period of 3 months.

Conditions

Hall Technique

Keywords

Hall Technique, Stainless-steel crowns, Preformed metal crowns, Dental anxiety.

Outcome Measures

Primary Outcomes (1)

• • Clinical and radiographic success (crown survival) assessed at 1, 2 and 3 months.

  * Major failures: Irreversible pulpitis, pulpal necrosis, abscess formation, inter- radicular radiolucency, or crown loss requiring replacement. * Minor failures: Reversible pulpitis, crown perforation, or development of new caries requiring intervention

  1,2,3 months

Other Outcomes (1)

• 1. Patient anxiety will be assessed using the Facial Image Scale (FIS) pre-treatment, immediately post-treatment, and during follow-ups. 2. Treatment time will be measured in minutes using a stopwatch. 3. Cost-effectiveness will be evaluated through dire

  1,2,3 months

Study Arms (2)

Hall technique

EXPERIMENTAL

molars undergo hall technique

Procedure: Hall Technique

Conventional stainless steel crown

ACTIVE COMPARATOR

molars recieving conventional stainless steel crown

Procedure: Conventional stainless steel crown

Interventions

Hall Technique PROCEDURE

primary molars undergoing hall technique

Hall technique

Conventional stainless steel crown PROCEDURE

primary molars undergoing conventional stainless steel crown

Conventional stainless steel crown

Eligibility Criteria

• Age: 5 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Only patients aged between 5-8 years old will be included in the study. The following criteria is used to determine eligibility to be part of the study:
• Only participants with one or two asymptomatic, vital primary molars following completion of treatment, will be able to participate in the clinical study .The posterior teeth may have multi-surface caries within the proximal and occlusal surfaces of the teeth, either one or both surfaces have been involved with caries and results in complete coronal coverage of the tooth.
• The posterior teeth included must show evidence of caries on x-rays (ICDAS 0-3), but with no evidence of pulp involvement/radicular pathology.
• All included teeth must be able to be restored and possess sufficient structure for retention of a preformed metal crown (PMC).
• Participants will be eligible if they demonstrate cooperation (i.e. Frankl behaviour rating 3-4) during examination/anesthesia/surgery.

You may not qualify if:

• o Any clinical symptoms or signs associated with pulpal pathology which could include sinus tract, spontaneous pain, tenderness to percussion or pathological mobility.
• Radiographic evidence of pulp involvement, furcation radiolucency or pathological root resorption exceeding one-third (1/3) of the root length were also considered.
• There are certain medical or systemic conditions/contra-indicators for routine dental treatment.
• Target teeth which have been previously restored have additional requirements.
• A follow-up appointment cannot occur because the parent/guardian will not be able to bring the child in for any follow-up appointments is another issue.

Sponsors & Collaborators

• MTI University: lead

Study Sites (1)

Pedodontics clinic - Faculty of Dentistry _ MTI University

Cairo, 11585, Egypt

RECRUITING

Central Study Contacts

Esraa Aly

CONTACT

+201006788341; esraahamed84@live.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Because the nature of the interventions made operator and participant blinding impractical, outcome assessors and the statistician were blinded to group allocation to minimize assessment and analysis bias. Participants self-reported their anxiety to minimize observer bias.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Pediatric Dentistry & Dental Public health

Study Record Dates

• First Submitted: June 7, 2026
• First Posted: June 15, 2026
• Study Start: May 25, 2026
• Primary Completion: May 25, 2026
• Study Completion (Estimated): August 25, 2026
• Last Updated: June 15, 2026

Record last verified: 2026-05

Locations

EG (1)