This randomized controlled clinical trial aims to compare two restorative techniques for managing carious primary molars in children aged 6-9 years: the Hall Technique and conventional stainless-steel crown (SSC) placement. The study evaluates how each technique affects occlusal force distribution, mean bite force, and vertical dimension changes using the T-Scan digital occlusal analysis system. Additional outcomes include temporomandibular joint assessment, child discomfort levels, and parental satisfaction with treatment. Participants are allocated 1:1 to receive either the Hall Technique or conventional SSC restoration, and outcomes are measured at baseline, immediately after treatment, and at 2- and 4-week follow-ups. The study aims to determine whether the minimally invasive Hall Technique provides comparable occlusal function and patient-centered outcomes when compared to traditional SSC preparation methods.
Systemically healthy children
Age ranging from 6 to 9 years
Cooperative behavior (positive rating on the Frankl Behavior Rating Scale)
Unrestored carious primary molar
Children with special health care needs
Temporomandibular disorders, bruxism or parafunctional habits
pathological facial swelling
periodontal diseases such as gingivitis, drug-induced gingival enlargement, juvenile or aggressive periodontitis
Parallel
Hall Technique Stainless Steel Crown Placement
Procedure/SurgeryChildren allocated to the intervention group will receive stainless-steel crown (SSC) placement using the Hall technique, without local anesthesia, caries removal, or tooth preparation. An appropriately sized preformed stainless-steel crown (NuSmile®) will be selected based on mesiodistal width and crown fit, and cemented using glass ionomer luting cement. Orthodontic separators may be placed when required to facilitate crown seating. No occlusal adjustment will be performed. Digital occlusal analysis and bite force assessment will be conducted using the T-Scan system, and vertical dimension will be measured using a digital caliper preoperatively, immediately after crown placement, and during the follow-up period according to the study schedule.
Conventional Stainless Steel Crown Placement
Procedure/SurgeryChildren allocated to the control group will receive conventional stainless-steel crown (SSC) restoration under local anesthesia following complete caries removal and standard tooth preparation, including occlusal reduction and proximal slicing. An appropriately sized preformed stainless-steel crown (NuSmile®) will be selected, adjusted if necessary, and cemented using glass ionomer luting cement. Occlusion will be clinically adjusted to eliminate premature contacts. Digital occlusal analysis and bite force assessment will be performed using the T-Scan system, and vertical dimension will be measured using a digital caliper preoperatively, immediately after crown placement, and during the follow-up period according to the study schedule.
Mean Bite Force
Occlusal evaluation for bite force will be done using T-Scan III. Changes in bite force at different periods will be assessed using a standardized T-Scan III Software. The obtained bite force will be recorded in percentage concerning the crowned tooth, opposing tooth, right and left side of the arch, during preoperative, postoperative and follow up periods after 2 and 4 weeks. The maximum intercuspal position (MIP) will be measured by changes in the bite force %.
Change in Vertical Dimension
The vertical dimension will be assessed to evaluate any changes in occlusal height following crown placement using either the Hall technique or the conventional stainless steel crown technique. Measurements will be taken using a digital caliper at four time points: preoperatively, immediately after crown placement, at 2 weeks, and at 4 weeks postoperatively. The vertical distance of the overbite will be measured in millimeters between the maxillary and mandibular canines while the child is in maximum intercuspal position. This outcome is used to detect temporary occlusal discrepancies and to monitor the process of occlusal re-equilibration over time following crown placement.
Temporomandibular Joint (TMJ) Assessment
Temporomandibular joint status will be evaluated using a standardized questionnaire based on the American Academy of Pediatric Dentistry (AAPD) guidelines. The assessment consists of binary (yes/no) questions addressing symptoms such as pain during chewing, jaw clicking, difficulty in mouth opening, jaw locking, or discomfort around the ears and cheeks. This outcome is measured to detect any functional disturbance associated with changes in occlusion after stainless steel crown placement by either technique.
Child Discomfort Level
The level of discomfort experienced by the child after crown placement will be assessed using the Wong-Baker FACES Pain Rating Scale. This validated tool allows children to express their perceived pain using facial expressions representing increasing levels of discomfort, ranging from 0 (no pain, smiling face) to 10 (worst pain, crying face), with intermediate scores of 2, 4, 6, and 8 corresponding to increasing pain intensity. This outcome helps compare patient tolerance and comfort between the minimally invasive Hall technique and the conventional stainless ste
Parental Satisfaction with Esthetics
Parental satisfaction with the esthetic appearance of the crown will be assessed using a structured questionnaire based on a five-point Likert scale. Parents will be asked to rate the size, shape, color, and overall appearance of the crown, with responses ranging from 1 (very dissatisfied), 2 (dissatisfied), 3 (neutral), 4 (satisfied), to 5 (very satisfied).
Map coordinates are unavailable for these locations. Locations are shown below instead.
EgyptClick on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
