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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Mean Bite Force
研究概览
简要总结
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.
详细描述
This randomized controlled clinical trial evaluates the effect of two restorative techniques-the Hall Technique and conventional stainless-steel crown (SSC) placement-on digital occlusal parameters and bite force distribution in carious primary molars. The study uses T-Scan digital occlusal analysis to objectively measure changes in occlusion and vertical dimension following restoration.
Children aged 6-9 years presenting with symptomless carious primary molars without pulpal involvement are eligible for inclusion. Participants are randomly assigned (1:1) to receive either an SSC placed using the Hall Technique (no caries removal or tooth preparation) or an SSC placed using the conventional technique (local anesthesia, caries removal, and tooth preparation). All clinical procedures are performed by a single operator to minimize performance bias, and the statistician is blinded during data analysis.
Digital occlusal analysis is conducted using T-Scan Novus to measure bite force percentage and maximum intercuspal position at baseline, immediately after crown placement, and at follow-up visits (2 and 4 weeks). Changes in vertical dimension are evaluated using a digital caliper at the same intervals. Secondary assessments include temporomandibular signs and symptoms, child discomfort, and parental satisfaction using validated questionnaires.
The primary objective is to compare mean biting force between the two restorative techniques over time. Secondary outcomes include changes in vertical dimension, presence of TMD-related symptoms, and subjective evaluations of comfort and esthetics. The study aims to provide clinical evidence regarding differences in occlusal equilibration and functional adaptation between biological minimally invasive management (Hall Technique) and the conventional restorative approach for carious primary molars.
Results from this trial may help guide clinical decision-making regarding restorative methods that optimize occlusion, patient comfort, and treatment acceptance in pediatric dentistry.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Systemically healthy children
- •Age ranging from 6 to 9 years
- •Cooperative behavior (positive rating on the Frankl Behavior Rating Scale)
- •Unrestored carious primary molar
- •Extent of caries radiographically confined to dentin (≤ or > ½ dentin thickness)
- •Tooth must be vital and symptomless, with no clinical or radiographic signs of pulpal pathology
排除标准
- •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
- •Any child showing mobility, bone loss, or signs of pulpal pathology is also excluded from the study.
结局指标
主要结局
Mean Bite Force
时间窗: Baseline (pre-operative), immediate post-operative, 2 weeks post-operative, 4 weeks post-operative
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 %.
次要结局
- Change in Vertical Dimension(Baseline (pre-operative), immediate post-operative, 2 weeks post-operative, 4 weeks post-operative)
- Temporomandibular Joint (TMJ) Assessment(Baseline (pre-operative) and 4 weeks post-operative)
- Child Discomfort Level(Immediate post-operative and 4 weeks post-operative)
- Parental Satisfaction with Esthetics(Immediate post-operative and 4 weeks post-operative)
- Parental Perception of Treatment Impact on the Child(Immediate post-operative and 4 weeks post-operative)
研究者
Lujain Yasser Wagih Youssef
Master's Student, Department of Pediatric Dentistry
Cairo University