Occlusal Impact of Hall Crowns in Primary Molars
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-10
SponsorAnkara Yildirim Beyazıt University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
No skeletal or dental anomalies,
ASA (American Society of Anesthesiologists) physical status classification of I or II ,
Frankl Behavior Rating Scale score of 3 or 4,
In the mixed dentition stage,
Disqualifiers
Individuals with serious systemic or psychological conditions
Participants who fail to attend follow-up appointments
Those who exhibit excessive fear or anxiety reactions and are unable to cooperate during treatment
Trial design
Design model
Parallel
Treatments tested in this trial
Hall Technique
Procedure/SurgeryProcedure: 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: * T0 (Baseline): Immediately before crown placement * T1 (Immediate): Immediately after crown placement * T2 (Two Weeks): Two weeks after crown placement * T3 (One Month): One month after crown placement At each time point (T0-T3), digital scans of both the upper and lower arches will be obtained, and a bite registration will be recorded. These records will be used to generate three-dimensional digital models, which will be analyzed to assess occlusal relationships and monitor changes over time.
Treatment groups
60 Participants
are divided into 4 treatment groupsGroup A: Maxillary First Primary MolarExperimental treatment 1 intervention
Group B: Maxillary Second Primary MolarActive comparator 1 intervention
Group C: Mandibular First Primary MolarActive comparator 1 intervention
Group D: Mandibular Second Primary MolarActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Cusp Tip Displacement (Linear Measurement in mm):
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 completion2
Vertical Positional Change of the Maxillary Primary Canine Cusp Tip (Linear Measurement in mm)
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 completion3
Vertical Positional Change of the Mesiobuccal Cusp Tips of All Permanent First Molars (Linear Measurement in mm)
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 completion4
Anterior Occlusal Vertical Dimension (Linear Measurement in mm)
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 completionSponsors and contacts
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Source ClinicalTrials.gov