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Starting soon Not applicable

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

NCT07792551 · tracked via the Priya Life Science Egypt tracker
Phase
Not applicable
Started
2026-10-01
Last updated
2026-08-28

Condition(s) studied

Clinical Effect

Investigational drug(s) / intervention(s)

SDF with stainless steel crownConventional Hall Technique

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

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

Study 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.

Eligibility

Sex
ALL
Min age
4 Years
Max age
8 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Patient-related inclusion criteria: 1. Children aged 4 to 8 years old. 2. One surface carious lesion. 3. No signs and symptoms. (e.g., no tooth pain) 4. Presence of one or more primary molar(s) with deep carious dentine. Tooth-related eligibility criteria: 1. Presence of active cavitated carious lesions that can be removed by an excavator are accessible with hand instruments. 2. Vital pulp with symptom-free or reversible pulpitis. 3. No spontaneous/prolonged pain or percussion pain. 4. No abnormal mobility or signs of infection (swelling, fistula, abscess). 5. Sufficient tooth structure for stainless steel crown retention. 6. Deep caries lesions radiographically extend through at least the inner half of the dentine. 7. Presence of a clear band of normal-appearing dentine between the carious lesion and the pulp in a bitewing radiograph. 8. More than 2/3 of the roots remaining. 9. No internal/external resorption or periapical/furcation pathology. Exclusion Criteria: * 1\. Presence of severe systemic medical conditions (e.g., uncontrolled diabetes, immunodeficiency disorders). 2\. Use of medications known to interfere with dental treatment or healing, such as anticoagulants or immunosuppressants. 3\. Presence of extensive dental caries or additional oral pathologies requiring urgent or specialized dental care beyond the scope of the study. 4\. 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). 6\. Unaffected dentine between lesion and pulp cannot be confirmed clinically/radiographically. 7\. Presence of extensive dental caries or additional oral pathology requiring urgent or specified dental care beyond scope of study.

Primary outcome measure(s)

  • Clinical evaluation — 12 months
    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)

Trial sites (1)

FacilityCityRegionStatus
Faculty of Dentistry, Cairo University, Cairo, Egypt. Cairo Cairo Governorate
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07792551 on ClinicalTrials.gov ↗ ← All trials in Egypt