Actively Recruiting

Phase Not Applicable
Age: 7Years - 10Years
All Genders
Healthy Volunteers
ID07134114

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

Led by Ankara Yildirim Beyazıt University · Updated on 2025-11-20

60

Participants Needed

1

Research Sites

21 weeks

Total Duration

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AI-Summary

What this Trial Is About

Researchers are evaluating the occlusal changes that happen after placing Hall crowns on different primary molar groups in children aged 7 to 10 years. The study aims to compare these changes among maxillary and mandibular first and second primary molars and to understand how the molar group and jaw location affect occlusal adaptation using digital model analysis. This study is a randomized controlled clinical trial conducted at a pediatric dentistry clinic. In this study, 60 children with at least two carious primary molars will receive a Hall crown on one randomly selected molar without local anesthesia or tooth preparation. The crown is a preformed stainless-steel crown cemented with glass ionomer cement. Participants are divided into four groups based on the treated molar: maxillary first or second molar and mandibular first or second molar. Digital intraoral scans will be taken before crown placement, immediately after, at two weeks, and at one month to assess occlusal changes. Participants will have digital scans and bite registrations taken at four time points to measure changes in tooth and cusp tip positions, occlusal vertical dimensions, and contact areas. Statistical analysis will compare these measurements among groups over time. All other necessary dental treatments will be completed before crown placement to avoid interference. The total participation lasts about one month with follow-up scans to monitor occlusal adaptation.

CONDITIONS

Brief Title

Occlusal Impact of Hall Crowns in Primary Molars

Who Can Participate

Age: 7Years - 10Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 7 to 10 years
  • No skeletal or dental anomalies
  • ASA 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
  • No acute dental pain or emergency treatment needed
  • At least two primary molars with carious lesions scored 3, 4, or 5 by ICDAS
  • Presence of an antagonist tooth for the treated molar
  • Verbal and written informed consent from participant and guardian
  • No history of prolonged or spontaneous pain suggesting irreversible pulpitis
  • No sensitivity to percussion or palpation
  • No pathological or physiological tooth mobility
  • No signs of swelling, fistula, or discoloration
  • Sufficient tooth structure to retain a stainless steel crown
  • Radiolucent carious lesion within outer one-third to two-thirds of dentin
  • At least two-thirds of root length present
  • No root resorption or bone loss
  • Intact lamina dura and normal periodontal ligament space
  • No calcified masses in the pulp chamber
Not Eligible

You will not qualify if you...

  • Serious systemic or psychological conditions
  • Failure to attend follow-up appointments
  • Excessive fear or anxiety preventing cooperation during treatment

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Baseline Assessment

Duration - 1 week

Participants undergo dental treatment to eliminate occlusal interferences and have a baseline digital intraoral scan taken prior to crown placement.

1 visit (in-person)

Treatment

Duration - Single day procedure

Participants receive a preformed stainless-steel crown placed on a primary molar using the Hall Technique without local anesthesia or caries removal.

1 visit (in-person)

Post-treatment Monitoring

Duration - 1 month

Participants have digital intraoral scans and bite registrations performed immediately after crown placement, at two weeks, and at one month to monitor occlusal changes.

3 visits (in-person) at immediate, 2 weeks, and 1 month post-treatment

Trial Site Locations

Total: 1 location

1

Ankara Yıldırım Beyazıt University Faculty of Dentistry

Ankara, Keçiören, Turkey (Türkiye)

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Research Team

A

Ayşe I. Cihan, Professor

E

Eylül Ü. Aykan

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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Published Research Related To This Trial

Evaluation of Changes in the Occlusion and Occlusal Vertical Dimension in Children Following the Placement of Preformed Metal Crowns Using the Hall Technique.

Rose Maria Joseph, Ashwin P Rao, N Srikant...

https://pubmed.ncbi.nlm.nih.gov/32271658

Short communication: Influence of preformed metal crowns (Hall technique) on the occlusal vertical dimension in the primary dentition.

V van der Zee, W E van Amerongen

https://pubmed.ncbi.nlm.nih.gov/20932395