Occlusal Impact of Hall Crowns in Primary Molars

NCT07134114 | Recruiting

• 1 other identifier: E2-25-11969
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dental Caries; Dental Occlusion; Pediatric Dentistry

Keywords

Hall technique; Occlusal adjustment; Intraoral scanning

Outcome Measures

Primary Outcomes (6)

• 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).

  From Hall crown placement to 1 month after treatment completion

• 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.

  From Hall crown placement to 1 month after treatment completion

• 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.

  From Hall crown placement to 1 month after treatment completion

• 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.

  From Hall crown placement to 1 month after treatment completion

• Posterior Occlusal Vertical Dimension (Linear Measurement in mm)

  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).

  From Hall crown placement to 1 month after treatment completion

• Change in Maximum Occlusal Contact Area (mm²)

  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).

  From Hall crown placement to 1 month after treatment completion

Study Arms (4)

Maxillary First Primary Molar

EXPERIMENTAL

A preformed metal crown will be placed and cemented on the carious maxillary first primary molar using the Hall Technique, without any tooth preparation or administration of local anesthesia.

Procedure: Hall Technique

Maxillary Second Primary Molar

ACTIVE COMPARATOR

A preformed metal crown will be placed and cemented on the carious maxillary second primary molar using the Hall Technique, without any tooth preparation or administration of local anesthesia.

Procedure: Hall Technique

Mandibular First Primary Molar

ACTIVE COMPARATOR

A preformed metal crown will be placed and cemented on the carious mandibular first primary molar using the Hall Technique, without any tooth preparation or administration of local anesthesia.

Procedure: Hall Technique

Mandibular Second Primary Molar

ACTIVE COMPARATOR

A preformed metal crown will be placed and cemented on the carious mandibular second primary molar using the Hall Technique, without any tooth preparation or administration of local anesthesia.

Procedure: Hall Technique

Interventions

Hall Technique PROCEDURE

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: * 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.

Mandibular First Primary Molar; Mandibular Second Primary Molar; Maxillary First Primary Molar; Maxillary Second Primary Molar

Eligibility Criteria

• Age: 7 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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,
• Fully erupted permanent first molars in occlusal contact at maximum intercuspation
• No acute dental pain or need for emergency treatment,
• Presence of at least two primary molars with carious lesions scored as 3, 4, or 5 according to the ICDAS (International Caries Detection and Assessment System),
• Presence of an antagonist tooth for the molar planned to receive Hall Technique,
• Provision of verbal and written informed consent by the participant and legal guardian after reading or listening to the consent form and fully understanding its content.
• Based on Clinical Examination:
• No history of prolonged pain in response to thermal or chemical stimuli, or spontaneous pain suggestive of irreversible pulpitis,
• No sensitivity to percussion or palpation,
• Absence of both pathological and physiological mobility,
• No signs of swelling, fistula, or discoloration,
• Sufficient remaining tooth structure to retain a preformed stainless steel crown.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara Yildirim Beyazıt University: lead

Study Sites (1)

Ankara Yıldırım Beyazıt University Faculty of Dentistry

Ankara, Keçiören, Turkey (Türkiye)

RECRUITING

Related Publications (5)

• Akyildiz BM, Al-Yaseen W, Innes N, Zhurov A, Tas A, Sonmez I. Longitudinal observational digital analysis of occlusion in Hall Technique. J Dent. 2025 Feb;153:105547. doi: 10.1016/j.jdent.2024.105547. Epub 2024 Dec 30.

  PMID: 39743130 BACKGROUND

• Joseph RM, Rao AP, Srikant N, Karuna YM, Nayak AP. Evaluation of Changes in the Occlusion and Occlusal Vertical Dimension in Children Following the Placement of Preformed Metal Crowns Using the Hall Technique. J Clin Pediatr Dent. 2020;44(2):130-134. doi: 10.17796/1053-4625-44.2.12.

  PMID: 32271658 BACKGROUND

• Kaya MS, Kinay Taran P, Bakkal M. Temporomandibular dysfunction assessment in children treated with the Hall Technique: A pilot study. Int J Paediatr Dent. 2020 Jul;30(4):429-435. doi: 10.1111/ipd.12620. Epub 2020 Feb 12.

  PMID: 31991506 BACKGROUND

• Gallagher S, O'Connell BC, O'Connell AC. Assessment of occlusion after placement of stainless steel crowns in children - a pilot study. J Oral Rehabil. 2014 Oct;41(10):730-6. doi: 10.1111/joor.12196. Epub 2014 Jun 10.

  PMID: 24913609 BACKGROUND

• van der Zee V, van Amerongen WE. Short communication: Influence of preformed metal crowns (Hall technique) on the occlusal vertical dimension in the primary dentition. Eur Arch Paediatr Dent. 2010 Oct;11(5):225-7. doi: 10.1007/BF03262751.

  PMID: 20932395 BACKGROUND

MeSH Terms

Conditions

Dental Caries; Bites and Stings

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Study Officials

• Ayşe I. Cihan, Professor

  Ankara Yıldırım Beyazit University Faculty of Dentistry

  STUDY CHAIR

Central Study Contacts

Ayşe I. Cihan, Professor

CONTACT

+905325095961; isilcihan@yahoo.com

Eylül Ü. Aykan

CONTACT

+905342820608; eylul.11235@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The biostatistician performing the data analysis will be blinded to group allocation. The clinician performing treatment and model analysis will not be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: August 21, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)