Hall Technique vs Conventional Crown Restoration in Permanent Molars: Split-Mouth Trial in Children

NCT ID: NCT07186673

Last Updated: 2025-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-30

Study Completion Date

2026-05-31

Brief Summary

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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.

Detailed Description

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Detailed Description of the Study

This clinical study is designed to evaluate and compare the clinical and radiographic effectiveness of the Hall Technique and the conventional crown placement method for restoring permanent first molars in children using a split-mouth design. The study will be conducted at the Department of Pediatric Dentistry, Faculty of Dentistry, Tishreen University.

A total of 10 pediatric patients will be recruited according to specific inclusion and exclusion criteria. Each child will present with at least two eligible permanent first molars requiring full coronal restoration with stainless steel crowns. In the split-mouth design, each child will serve as their own control: one molar will be treated using the Hall Technique (HT), and the contralateral molar will be restored using the conventional method. The allocation of which technique will be applied to which side will be randomized for each patient to minimize bias.

Inclusion criteria will include:

* Permanent first molars with carious lesions affecting two or more surfaces or presenting Molar Incisor Hypomineralization (MIH).
* Absence of clinical signs or symptoms of irreversible pulpitis.
* Radiographic confirmation of an intact dentin layer and absence of internal or external root resorption or periapical pathology.

Exclusion criteria will include:

* Known allergy to nickel.
* Severely broken-down molars not suitable for SSC placement.
* Missing opposing teeth.
* Pulpal exposure during treatment.

In the HT group, stainless steel crowns will be placed without local anesthesia, without caries removal, and without any tooth preparation. Orthodontic separators will be placed if necessary during the first visit, and crown cementation will be performed using glass ionomer cement (GIC) during the follow-up visit.

In the conventional group, local anesthesia will be administered, and standard tooth preparation will be carried out (occlusal and proximal reduction), followed by fitting and cementation of the stainless steel crown using GIC.

Clinical and radiographic evaluations will be conducted at multiple time points: at baseline, 1 week, 1 month, 3 months, and 6 months post-treatment. These evaluations will aim to assess the success of the restoration based on crown integrity, presence of clinical symptoms, and radiographic signs of pulpal or periapical pathology.

Patient satisfaction will be measured using a five-point Likert scale, recorded immediately after treatment and again at 1 month, 3 months, and 6 months.

The primary outcome of the study will be the clinical and radiographic success of the restorations.

The secondary outcomes will include assessment of marginal fit and crown adaptation, changes in occlusal relationships (overbite), and patient satisfaction.

Conditions

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Permanent Molars Dental Caries Tooth Decay Permanent First Molar Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Hall Technique

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.

Group Type EXPERIMENTAL

Stainless steel crown placement using Hall Technique

Intervention Type DEVICE

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

Conventional Crown Preparation

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.

Group Type ACTIVE_COMPARATOR

Stainless steel crown placement using conventional method

Intervention Type DEVICE

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.

Interventions

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Stainless steel crown placement using Hall Technique

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

Intervention Type DEVICE

Stainless steel crown placement using conventional method

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

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

8 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tishreen University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nabih Raslan

Role: STUDY_CHAIR

Tishreen University

Locations

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Faculty of Dentistry, Tishreen University

Latakia, , Syria

Site Status

Countries

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Syria

Central Contacts

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Nabih Raslan, Prof

Role: CONTACT

+963999140762

Ahmad Obaid Alhay

Role: CONTACT

+994311031

Facility Contacts

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Ahmad Obaid Alhay

Role: primary

+963994311031

Nabih Raslan

Role: backup

Other Identifiers

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Hall T in Permanent Molars

Identifier Type: -

Identifier Source: org_study_id

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