About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Hall Technique
Procedure/Surgeryprimary molars undergoing hall technique
Conventional stainless steel crown
Procedure/Surgeryprimary molars undergoing conventional stainless steel crown
Treatment groups
Trial outcomes
Primary outcomes
• 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
Other outcomes
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. 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 direct cost analysis and calculation of the incremental cost-effectiveness ratio (ICER) based on quality-adjusted tooth years (QATY). 4. Gingival and plaque indices will be recorded using the Löe and Silness Gingival Index and Plaque Index. 5. Occlusal status is assessed clinically at each follow-up visit.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.