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Dental CariesNCT07134114

Occlusal Impact of Hall Crowns in Primary Molars

A study testing Hall Technique in people with Dental Caries and Dental Occlusion, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 7 to 10 yearsHealthy volunteers can take part
What is being tested?
Hall Technique
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Sep 2025to 15 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 to 10 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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,
Show all 22Show fewer
  • 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.
  • Based on Radiographic Examination:
  • Radiolucent lesion associated with dental caries located within the outer one-third to two-thirds of the dentin, with a visible band of normal dentin between the lesion and the pulp,
  • At least two-thirds of root length present,
  • No signs of internal or external pathological or physiological root resorption,
  • Intact lamina dura and normal periodontal ligament space,
  • No periradicular bone loss surrounding the roots,
  • No calcified masses in the pulp chamber.

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ayşe I. Cihan, Professor contact

+905325095961

isilcihan@yahoo.com

Eylül Ü. Aykan contact

+905342820608

eylul.11235@gmail.com

Turkey (Türkiye)1 site, 1 recruiting
  • Ankara Yıldırım Beyazıt University Faculty of Dentistry

    Ankara, Keçiören

    Ayşe Işıl Cihan, Professor, +90 532 509 59 61, isilcihan@yahoo.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: Comparative Evaluation of Occlusal Changes Following Hall Technique Crowns in Different Primary Molar Groups: A Randomized Controlled Clinical 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.

Read the detailed description

The aim of this clinical study is:

  • to evaluate the occlusal changes that occur following the Hall Technique in different primary molar groups.
  • to investigate whether the molar group (first vs. second) and jaw location (maxilla vs. mandible) influence the degree or pattern of occlusal adaptation.

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:

  • Positional change (in mm) between the mesiobuccal, distobuccal, mesiolingual/palatal, and distolingual/palatal cusp tips of the Hall-treated tooth, as well as the cusp tips of the opposing teeth in maximum intercuspation with this tooth.
  • Positional change (in mm) of the cusp tip of the maxillary primary canine on the same side as the treated tooth
  • Positional change (in mm) between the mesiobuccal cusp tips of all permanent first molars,
  • Change in anterior occluso-vertical dimension (in mm)
  • Change in posterior occluso-vertical dimension (in mm)
  • Change (in mm²) in the surface area of maximum occlusal contact regions, based on digital bite registration records.

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.

Being tested
Hall Technique
Keywords
Hall technique, Occlusal adjustment, Intraoral scanning
Medical subject headings
Dental Caries, Bites and Stings

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hall TechniqueProcedure or surgery

    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.
Study groups in NCT07134114
Study groupRoleWhat they receive
Maxillary First Primary MolarExperimentalA 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.
Receives: Procedure: Hall Technique
Maxillary Second Primary MolarActive comparatorA 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.
Receives: Procedure: Hall Technique
Mandibular First Primary MolarActive comparatorA 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.
Receives: Procedure: Hall Technique
Mandibular Second Primary MolarActive comparatorA 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.
Receives: Procedure: Hall Technique

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: From Hall crown placement to 1 month after treatment completion

  2. 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.

    Measured: From Hall crown placement to 1 month after treatment completion

  3. 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.

    Measured: From Hall crown placement to 1 month after treatment completion

  4. 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.

    Measured: From Hall crown placement to 1 month after treatment completion

  5. 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).

    Measured: From Hall crown placement to 1 month after treatment completion

  6. 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).

    Measured: From Hall crown placement to 1 month after treatment completion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2025
  2. Study start15 Sep 2025
  3. Primary completion15 Jul 2026 (estimated)
  4. Study completion15 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07134114
Sponsor's protocol ID
E2-25-11969
Status last verified
Nov 2025
First submitted
14 Aug 2025
Last updated
20 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 39743130
  • 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.

    PubMed 32271658
  • 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.

    PubMed 31991506
  • 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.

    PubMed 24913609
  • 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.

    PubMed 20932395

Questions about this trial

What is this clinical trial studying?

A study testing Hall Technique in people with Dental Caries and Dental Occlusion, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ayşe I. Cihan, Professor (+905325095961, isilcihan@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cusp Tip Displacement (Linear Measurement in mm): (time frame: From Hall crown placement to 1 month after treatment completion). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07134114, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.

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