NCT07186673

Brief Summary

The aim of this study is to compare the clinical and radiographic success of stainless steel crowns placed using the Hall Technique versus the conventional method in the restoration of permanent first molars in children, and to evaluate their effects on occlusal relationships, crown adaptation, and patient satisfaction. Study Outcomes The primary outcome of this study was to evaluate the clinical and radiographic success of stainless steel crowns placed on permanent first molars using the Hall Technique in comparison to the conventional crown placement method. The secondary outcomes included assessment of the marginal fit and adaptation of preformed crowns using both techniques, analysis of changes in occlusal relationships-specifically the vertical dimension of occlusion and overbite-and evaluation of patient satisfaction. Patient satisfaction was measured using a five-point Likert scale at multiple time points: immediately post-treatment, and at one, three, and six months.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 7, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 22, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

November 28, 2025

Status Verified

November 1, 2025

Enrollment Period

5 months

First QC Date

September 7, 2025

Last Update Submit

November 23, 2025

Conditions

Keywords

Hall TechniqueStainless Steel CrownsPermanent First MolarsDental Caries

Outcome Measures

Primary Outcomes (1)

  • Clinical and Radiographic Success

    Clinical and Radiographic Success Definition: Absence of clinical symptoms (pain, swelling, mobility) and absence of radiographic signs of pathology (periapical radiolucency, internal/external resorption).

    Baseline, 1 month, 3 months, and 6 months

Secondary Outcomes (1)

  • - Marginal Fit and Adaptation - Changes in Occlusion ( Overbite) - Patient Satisfaction (Likert Scale)

    Time Frame: Immediately post-treatment, 1 month, 3 months, and 6 months

Study Arms (2)

Hall Technique

EXPERIMENTAL

Permanent first molars are restored using the Hall Technique. No local anesthesia, caries removal, or tooth preparation is performed. Orthodontic separators are placed if needed, followed by stainless steel crown (SSC) cementation using glass ionomer cement.

Device: Stainless steel crown placement using Hall Technique

Conventional Crown Preparation

ACTIVE COMPARATOR

Permanent first molars are restored using the conventional method. Local anesthesia is administered, and the tooth is prepared with occlusal and proximal reduction before placement and cementation of a stainless steel crown using glass ionomer cement.

Device: Stainless steel crown placement using conventional method

Interventions

Preformed stainless steel crowns are placed on permanent first molars without local anesthesia, caries removal, or tooth preparation. Orthodontic separators are used as needed, and crowns are cemented with glass ionomer cement

Hall Technique

Preformed stainless steel crowns are placed after administering local anesthesia and performing standard tooth preparation, including occlusal and proximal reduction. Crowns are cemented with glass ionomer cement.

Conventional Crown Preparation

Eligibility Criteria

Age8 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • No signs or symptoms of irreversible pulpitis
  • Molars with carious lesions affecting two or more surfaces
  • Permanent first molars with developmental defects
  • First molars with an intact dentin layer visible radiographically
  • No signs of internal or external resorption
  • No evidence of periradicular bone resorption

You may not qualify if:

  • Patients with known nickel allergy
  • Severely damaged molars not restorable with preformed crowns
  • First molars without opposing teeth
  • Pulp exposure during caries excavation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Tishreen University

Latakia, Syria

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Nabih Raslan

    Tishreen University

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Model Description: This is a randomized, controlled, split-mouth clinical trial in which each participant receives both interventions: the Hall Technique and the conventional crown preparation method. Each technique is applied to a different permanent first molar within the same child, allowing for direct within-subject comparison. Treatment allocation to the left or right molar is randomized. This design minimizes inter-individual variability and enhances the reliability of outcome comparisons.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2025

First Posted

September 22, 2025

Study Start

November 1, 2025

Primary Completion

April 1, 2026

Study Completion

May 1, 2026

Last Updated

November 28, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

The decision regarding IPD sharing has not been finalized. Will follow institutional and regulatory guidelines.

Locations