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Carious Primary MolarsNCT07295574

Digital Occlusal Analysis and Bite Force Evaluation of the Hall Technique Vs Stainless Steel Crowns in Primary Molars Using T-scan

A study testing Hall Technique Stainless Steel Crown Placement and Conventional Stainless Steel Crown Placement in people with Carious Primary Molars and Bite Force, run by Cairo University at 1 site in Egypt.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 6 to 9 years
What is being tested?
Hall Technique Stainless Steel Crown Placement and Conventional Stainless Steel Crown Placement
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteEgypt
Study dates
Jan 2026to Mar 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 6 to 9 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

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

Lujain Y Wagih Youssef, B.D.S Faculty of Dentistry contact

+201097906344

lujain.yasser@dentistry.cu.edu.eg

Egypt1 site

  • Cairo University

    Cairo, Giza Governorate, 12613

    Prof.Dr. Osama A El Shahawy, PhD, +201005634755, osama.shahawy@dentistry.cu.edu.eg

Other trials in Egypt

About this study

Official title: 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

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.

Read the detailed description

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.

Being tested
Hall Technique Stainless Steel Crown Placement, Conventional Stainless Steel Crown Placement
Keywords
Hall Technique, Stainless Steel Crown, Carious Primary Molars, Digital Occlusal Analysis, T-Scan, Bite Force, Occlusal Force Distribution, Vertical Dimension, Pediatric Dentistry, Minimal Intervention Dentistry, Conventional Crown Preparation, Randomized Clinical Trial

What participants receive

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

  • Hall Technique Stainless Steel Crown PlacementProcedure or surgery

    Children allocated to the intervention group will receive stainless-steel crown (SSC) placement using the Hall technique, without local anesthesia, caries removal, or tooth preparation. An appropriately sized preformed stainless-steel crown (NuSmile®) will be selected based on mesiodistal width and crown fit, and cemented using glass ionomer luting cement. Orthodontic separators may be placed when required to facilitate crown seating. No occlusal adjustment will be performed. Digital occlusal analysis and bite force assessment will be conducted using the T-Scan system, and vertical dimension will be measured using a digital caliper preoperatively, immediately after crown placement, and during the follow-up period according to the study schedule.

  • Conventional Stainless Steel Crown PlacementProcedure or surgery

    Children allocated to the control group will receive conventional stainless-steel crown (SSC) restoration under local anesthesia following complete caries removal and standard tooth preparation, including occlusal reduction and proximal slicing. An appropriately sized preformed stainless-steel crown (NuSmile®) will be selected, adjusted if necessary, and cemented using glass ionomer luting cement. Occlusion will be clinically adjusted to eliminate premature contacts. Digital occlusal analysis and bite force assessment will be performed using the T-Scan system, and vertical dimension will be measured using a digital caliper preoperatively, immediately after crown placement, and during the follow-up period according to the study schedule.

Study groups in NCT07295574
Study groupRoleWhat they receive
Hall Technique Stainless-Steel Crown PlacementExperimentalParticipants in this arm will receive a stainless-steel crown (NuSmile) placed using the Hall Technique, a minimally invasive method that does not require local anesthesia, caries removal, or tooth preparation. The appropriately sized crown will be selected based on mesiodistal measurements and trial fitting, then cemented using glass ionomer luting cement. Orthodontic separators may be placed when contacts are tight. Outcome measurements (T-Scan bite force, vertical dimension, questionnaires) will be taken at baseline, immediately after placement, and at 2- and 4-week follow-ups.
Receives: Procedure: Hall Technique Stainless Steel Crown Placement
Conventional Stainless-Steel Crown RestorationActive comparatorParticipants in this arm will receive a stainless-steel crown (NuSmile) placed using the traditional conventional technique. This includes local anesthesia, complete caries removal, and tooth preparation (occlusal reduction ~1.5 mm, proximal slicing). The crown will be fitted, adjusted for proper occlusion, and cemented using glass ionomer luting cement. Standardized outcome measurements (T-Scan bite force, vertical dimension, questionnaires) will be recorded at baseline, immediately post-operatively, and at 2- and 4-week follow-ups.
Receives: Procedure: Conventional Stainless Steel Crown Placement

What is being measured

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

  1. Mean Bite Force

    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 %.

    Measured: Baseline (pre-operative), immediate post-operative, 2 weeks post-operative, 4 weeks post-operative

Secondary outcomes (5)

  1. Change in Vertical Dimension

    The vertical dimension will be assessed to evaluate any changes in occlusal height following crown placement using either the Hall technique or the conventional stainless steel crown technique. Measurements will be taken using a digital caliper at four time points: preoperatively, immediately after crown placement, at 2 weeks, and at 4 weeks postoperatively. The vertical distance of the overbite will be measured in millimeters between the maxillary and mandibular canines while the child is in maximum intercuspal position. This outcome is used to detect temporary occlusal discrepancies and to monitor the process of occlusal re-equilibration over time following crown placement.

    Measured: Baseline (pre-operative), immediate post-operative, 2 weeks post-operative, 4 weeks post-operative

  2. Temporomandibular Joint (TMJ) Assessment

    Temporomandibular joint status will be evaluated using a standardized questionnaire based on the American Academy of Pediatric Dentistry (AAPD) guidelines. The assessment consists of binary (yes/no) questions addressing symptoms such as pain during chewing, jaw clicking, difficulty in mouth opening, jaw locking, or discomfort around the ears and cheeks. This outcome is measured to detect any functional disturbance associated with changes in occlusion after stainless steel crown placement by either technique.

    Measured: Baseline (pre-operative) and 4 weeks post-operative

  3. Child Discomfort Level

    The level of discomfort experienced by the child after crown placement will be assessed using the Wong-Baker FACES Pain Rating Scale. This validated tool allows children to express their perceived pain using facial expressions representing increasing levels of discomfort, ranging from 0 (no pain, smiling face) to 10 (worst pain, crying face), with intermediate scores of 2, 4, 6, and 8 corresponding to increasing pain intensity. This outcome helps compare patient tolerance and comfort between the minimally invasive Hall technique and the conventional stainless ste

    Measured: Immediate post-operative and 4 weeks post-operative

  4. Parental Satisfaction with Esthetics

    Parental satisfaction with the esthetic appearance of the crown will be assessed using a structured questionnaire based on a five-point Likert scale. Parents will be asked to rate the size, shape, color, and overall appearance of the crown, with responses ranging from 1 (very dissatisfied), 2 (dissatisfied), 3 (neutral), 4 (satisfied), to 5 (very satisfied).

    Measured: Immediate post-operative and 4 weeks post-operative

  5. Parental Perception of Treatment Impact on the Child

    Parents will evaluate the overall impact of the treatment on their child using a structured questionnaire with a five-point Likert scale, with responses ranging from 1 (not at all satisfied) to 5 (very much satisfied). The questionnaire will assess the following aspects: improvement in the child's oral health after crown placement, parents' concern about the appearance of the teeth before crowns, whether the child avoided smiling before crowns, whether the child smiled after crowns, and whether the crowns improved the overall appearance of the child's teeth. This outcome helps assess the psychosocial and functional impact of both the Hall technique and the conventional stainless steel crown technique from the caregiver's perspective.

    Measured: Immediate post-operative and 4 weeks post-operative

Timeline

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

  1. First posted19 Dec 2025
  2. Study startJan 2026 (estimated)
  3. Primary completionMar 2026 (estimated)
  4. Study completionMar 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
Model description
This study is designed as a prospective, parallel group, randomized controlled clinical trial with a 1:1 allocation ratio, comparing two restorative techniques for carious primary molars: the Hall Technique (intervention) and the conventional stainless-steel crown (control).
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
22 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07295574
Sponsor's protocol ID
HT-SSC-TSCAN-RCT-2025
Status last verified
Dec 2025
First submitted
3 Dec 2025
Last updated
19 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Umapathy Thimmegowda and Radhakrishnan, A. (2023). Application of Tekscan in Pediatric Dentistry:AReview.pp.132-142. doi:Hall techniquetps://doi.org/10.9734/bpi/cidhr/v1/6603a

  • Schuler IM, Hiller M, Roloff T, Kuhnisch J, Heinrich-Weltzien R. Clinical success of stainless steel crowns placed under general anaesthesia in primary molars: an observational follow up study. J Dent. 2014 Nov;42(11):1396-403. doi: 10.1016/j.jdent.2014.06.009. Epub 2014 Jun 30.

    PubMed 24994618

  • Herkar PP, Anantharaj A, Praveen P, Shankarappa PR, Sudhir R. A comparative study of conventional and Hall techniques of crown placement using finite element stress analysis. J Indian Soc Pedod Prev Dent. 2022 Jul-Sep;40(3):302-310. doi: 10.4103/jisppd.jisppd_173_22.

    PubMed 36260472

  • Rahate I, Fulzele P, Thosar N. Comparative evaluation of clinical performance, child and parental satisfaction of Bioflx, zirconia and stainless steel crowns in pediatric patients. F1000Res. 2023 Dec 21;12:756. doi: 10.12688/f1000research.133464.2. eCollection 2023.

    PubMed 38911945

  • Hu S, BaniHani A, Nevitt S, Maden M, Santamaria RM, Albadri S. Hall technique for primary teeth: A systematic review and meta-analysis. Jpn Dent Sci Rev. 2022 Nov;58:286-297. doi: 10.1016/j.jdsr.2022.09.003. Epub 2022 Sep 27.

    PubMed 36185501

  • Boyd DH, Thomson WM, Leon de la Barra S, Fuge KN, van den Heever R, Butler BM, Leov F, Foster Page LA. A Primary Care Randomized Controlled Trial of Hall and Conventional Restorative Techniques. JDR Clin Trans Res. 2021 Apr;6(2):205-212. doi: 10.1177/2380084420933154. Epub 2020 Jun 19.

    PubMed 32559403

  • Ayedun OS, Oredugba FA, Sote EO. Comparison of the treatment outcomes of the conventional stainless steel crown restorations and the hall technique in the treatment of carious primary molars. Niger J Clin Pract. 2021 Apr;24(4):584-594. doi: 10.4103/njcp.njcp_460_20.

    PubMed 33851682

  • Araujo MP, Uribe S, Robertson MD, Mendes FM, Raggio DP, Innes NPT. The Hall Technique and exfoliation of primary teeth: a retrospective cohort study. Br Dent J. 2020 Feb;228(3):213-217. doi: 10.1038/s41415-020-1251-1.

    PubMed 32060464

  • Amlani DV, Brizuela M. Stainless Steel Crowns in Primary Dentition. 2023 Mar 19. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK574547/

    PubMed 34662061

  • Nair K, Chikkanarasaiah N, Poovani S, Thumati P. Digital occlusal analysis of vertical dimension and maximum intercuspal position after placement of stainless steel crown using hall technique in children. Int J Paediatr Dent. 2020 Nov;30(6):805-815. doi: 10.1111/ipd.12647. Epub 2020 May 7.

    PubMed 32248585

  • Maheshkumar K, Chowdhary N, Chowdharry R, Vundela RR, Sonnahalli NK, Anuraaga AT. Bite force evaluation at maximal intercuspal position: An in vivo comparative study between stainless steel and zirconia crowns on primary molar teeth. J Indian Soc Pedod Prev Dent. 2023 Apr-Jun;41(2):89-97. doi: 10.4103/jisppd.jisppd_156_23.

    PubMed 37635466

  • Bhatia HP, Khari PM, Sood S, Sharma N, Singh A. Evaluation of Clinical Effectiveness and Patient Acceptance of Hall Technique for Managing Carious Primary Molars: An In Vivo Study. Int J Clin Pediatr Dent. 2019 Nov-Dec;12(6):548-552. doi: 10.5005/jp-journals-10005-1699.

    PubMed 32440073

  • Aishwarya N, Nagarathna C, Poovani S, Thumati P. Comparison of Bite Force and the Influencing Factors Pre- and Post-cementation of Stainless Steel Crown in Children Using T-Scan. Int J Clin Pediatr Dent. 2021 Jan-Feb;14(1):46-50. doi: 10.5005/jp-journals-10005-1900.

    PubMed 34326583

Questions about this trial

What is this clinical trial studying?

A study testing Hall Technique Stainless Steel Crown Placement and Conventional Stainless Steel Crown Placement in people with Carious Primary Molars and Bite Force, run by Cairo University at 1 site in Egypt.

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 6 inclusion and 5 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: opening soon, as of the sponsor's last update on 19 Dec 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 Egypt. 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 Lujain Y Wagih Youssef, B.D.S Faculty of Dentistry (+201097906344, lujain.yasser@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Bite Force (time frame: Baseline (pre-operative), immediate post-operative, 2 weeks post-operative, 4 weeks post-operative). 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 NCT07295574, which also lists 13 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 19 Dec 2025.

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