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

Not Applicable

Not yet recruiting

• Conditions: Permanent Molars; Dental Caries; Tooth Decay; Permanent First Molar Caries

• Registration Number: NCT07186673
• Lead Sponsor: Tishreen University

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2025-09
• Study Start: 2025-09-01
• Study First Submitted: 2025-09-07
• Study First Submitted QC: 2025-09-18
• Last Update Submitted: 2025-09-18
• Study First Posted: 2025-09-22
• Last Update Posted: 2025-09-22
• Primary Completion: 2026-03
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Clinical and Radiographic Success	Baseline, 1 month, 3 months, and 6 months	Clinical and Radiographic Success Definition: Absence of clinical symptoms (pain, swelling, mobility) and absence of radiographic signs of pathology (periapical radiolucency, internal/external resorption).

Secondary Outcome Measures

Name	Time	Method
- Marginal Fit and Adaptation - Changes in Occlusion ( Overbite) - Patient Satisfaction (Likert Scale)	Time Frame: Immediately post-treatment, 1 month, 3 months, and 6 months	Secondary Outcome Measures; Marginal Fit and Adaptation of Crown Definition: Clinical assessment of marginal adaptation (good, acceptable, poor).; Time Frame: Post-treatment, 1 month, 3 months, and 6 months; Changes in Occlusion (Overbite) Definition: Measurement of changes in vertical dimension of occlusion and overbite using clinical examination.; Time Frame: Post-treatment, 1 month, 3 months, and 6 months; Patient Satisfaction (Five-Point Likert Scale) Definition: Patient-reported satisfaction using a 5-point Likert scale (1 = very dissatisfied, 5 = very satisfied). Higher scores indicate greater satisfaction.; Time Frame: Immediately post-treatment, 1 month, 3 months, and 6 months

Trial Locations

Locations (1)

Faculty of Dentistry, Tishreen University; 🇸🇾 Latakia, Syria