Ankara Yıldırım Beyazıt University Faculty of Dentistry
Ankara, Keçiören, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07134114
Hall Technique is a non-invasive restorative approach for managing carious primary molars, increasingly used in pediatric dentistry due to its simplicity and patient tolerance. This study aims to evaluate and compare the occlusal changes that occur following Hall crown placement on different primary molar groups (maxillary first molar, maxillary second molar, mandibular first molar, mandibular second molar) using digital model analysis.
Interested in participating?
Request Info7 year–10 year
All sexes
Interventional
Not applicable
Ankara, Keçiören, Turkey (Türkiye)
Location status: Recruiting
The aim of this clinical study is:
A total of 60 healthy children aged between 7 and 10 years will be recruited from the Pediatric Dentistry Clinic at Ankara Yıldırım Beyazıt University, Faculty of Dentistry. Patients must have at least two primary molars requiring restorative treatment and meet all inclusion criteria.
After obtaining informed consent from parents and assent from the child, one eligible primary molar per participant will be randomly selected for Hall crown placement using a computer-generated allocation system. Based on the selected tooth, participants will be stratified into four groups: Group 1 (Maxillary first primary molar), Group 2 (Maxillary second primary molar), Group 3 (Mandibular first primary molar), and Group 4 (Mandibular second primary molar). Following group allocation, all other necessary dental treatments-including conventional restorations, endodontic procedures, and preventive interventions-will be completed to eliminate potential occlusal interferences.
One week after the completion of all dental treatments other than the Hall Technique, a baseline digital intraoral scan will be obtained using the Trios 3 scanner (3Shape, Copenhagen, Denmark), prior to crown placement on the designated primary molar. The Hall Technique will then be applied without local anesthesia or any caries removal. Debris will be gently cleared from the cavity, and airway protection will be ensured using gauze or elastoplast fixation. An appropriately sized preformed stainless-steel crown will be filled with glass ionomer cement (3M Ketac Cem) and seated on the tooth. The child will be instructed to bite firmly to ensure crown placement, or finger pressure will be used if necessary. Excess cement will be removed and interproximal contacts will be cleaned with dental floss. Digital intraoral scans will be repeated at three additional time points: immediately after crown placement (T1), at two weeks (T2), and at one month (T3) post-treatment. Superimposition and occlusal analysis will be conducted using Trios CAD (Computer-Aided Design) software to evaluate changes in occlusal parameters over time.
Following parameters will be quantitatively assessed:
Statistical analysis will involve comparing changes in linear (mm) and surface area (mm²) measurements across the four study groups at multiple time intervals (T0-T1, T0-T2, T0-T3, T1-T2, T1-T3, and T2-T3). Data distribution will be assessed using the Shapiro-Wilk test. Group comparisons will be performed using ANOVA, Kruskal-Wallis, chi-square, and two-way mixed ANOVA or F1-LD-F1 design, as appropriate. Bonferroni correction will be applied for post hoc tests, and p ≤ 0.05 will be considered statistically significant. Analyses will be conducted using SPSS v.23 and R software.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Inclusion criteria
for Participants
Inclusion criteria
for Tooth
Based on Clinical Examination:
Based on Radiographic Examination:
Exclusion criteria
Procedure: Hall Technique A preformed stainless-steel crown will be placed on a primary molar using the Hall Technique. This approach does not require local anesthesia, caries removal, or tooth preparation.
Digital Scan and Bite Registration Schedule:
Time frame: From Hall crown placement to 1 month after treatment completion
The positional changes of the mesiobuccal, distobuccal, mesiolingual/palatal, and distolingual/palatal cusp tips of the crowned primary molar, as well as the cusp tips of the opposing teeth in maximum intercuspation with this tooth, will be measured by comparing the distances between each cusp tip across time points: T0 (immediately before crown placement), T1 (immediately after crown placement), T2 (two weeks after crown placement), and T3 (one month after crown placement).
Time frame: From Hall crown placement to 1 month after treatment completion
The vertical distance of the cusp tip of the maxillary primary canine located on the same side as the treated tooth will be measured at each time point: T0 (immediately before crown placement), T1 (immediately after crown placement), T2 (two weeks after crown placement), and T3 (one month after crown placement). The measurements will be compared within the same tooth across time points to assess any vertical displacement over time.
Time frame: From Hall crown placement to 1 month after treatment completion
The vertical positions of the mesiobuccal cusp tips of all permanent first molars will be measured at each time point: T0 (immediately before crown placement), T1 (immediately after crown placement), T2 (two weeks after crown placement), and T3 (one month after crown placement). Intra-tooth comparisons will be performed to evaluate any vertical changes over time.
Time frame: From Hall crown placement to 1 month after treatment completion
The anterior occlusal vertical dimension will be assessed by measuring the vertical distance between the cusp tip of the maxillary primary canine and the cusp tip of the mandibular primary or permanent canine on the same side as the treated tooth. This measurement will be performed in maximum intercuspation at all time points: T0 (immediately before crown placement), T1 (immediately after crown placement), T2 (two weeks after crown placement), and T3 (one month after crown placement). If the mandibular primary or permanent canine on the same side is not present or cannot be measured, the corresponding canine on the contralateral side will be used.
Time frame: From Hall crown placement to 1 month after treatment completion
The posterior occlusal vertical dimension will be evaluated by measuring the vertical distance between the mesiobuccal cusp tips of the opposing maxillary and mandibular permanent first molars on the same side as the treated tooth. This measurement will be taken in maximum intercuspation at all time points: T0 (immediately before crown placement), T1 (immediately after crown placement), T2 (two weeks after crown placement), and T3 (one month after crown placement).
Time frame: From Hall crown placement to 1 month after treatment completion
The change in maximum occlusal contact areas (in mm²) will be analyzed based on bite registration records. Since the Trios 3 software does not allow direct quantitative measurement of occlusal contact areas, the analysis will be performed using the color-coded occlusal contact maps generated by the software. Specifically, the red zones representing the areas of maximum contact will be identified from the screenshots, and their surface areas will be measured using the ImageJ software. This analysis will be two-dimensional, based on calibrated screenshots, and will provide a comparative assessment of occlusal contact area changes across different time points: T0 (immediately before crown placement), T1 (immediately after crown placement), T2 (two weeks after crown placement), and T3 (one month after crown placement).
Contact information is provided by the study sponsor or research team.
Ayşe I. Cihan, Professor
CONTACT
Eylül Ü. Aykan
CONTACT
Ankara Yildirim Beyazıt University
Other
Comparative Evaluation of Occlusal Changes Following Hall Technique Crowns in Different Primary Molar Groups: A Randomized Controlled Clinical Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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