Injectable Bioactive Composite vs Hall Technique for Proximal Cavities in Primary Molars

Clinical Evaluation of Injectable Bioactive Composites vs Hall Technique for Restoring Proximal Cavities in Primary Molars: A Randomized Clinical Trial

This randomized clinical trial compares the survival rate and clinical performance of injectable bioactive giomer composite restorations versus the Hall Technique for managing proximal carious lesions (ICDAS 3-4) in primary molars of children aged 3-8 years over a 12-month follow-up period.

Study Overview

• Status: Not yet recruiting
• Conditions: Dental Caries
• Intervention / Treatment: Other: hall technique; Other: giomer

Detailed Description

Children aged 3-8 years with proximal carious lesions in primary molars will be randomly assigned to receive either an injectable bioactive giomer restoration (Beautifil Flow Plus X, Shofu) or a Hall Technique preformed metal crown. Clinical outcomes will be assessed at baseline, 3, 6, and 12 months using survival rate criteria (Innes et al., 2007) and FDI criteria for biological properties.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• • Generally showing cooperative behaviour that could be managed by the operators.

  • Willing to sign the informed consent.
  • Accepts the follow-up period.
  • Moderate to low caries risk according to cariogram application
  • Posterior primary molar with proximal carious lesion with no sign and symptoms of pulpal involvement.
  • Radiographically (bitewing radiograph) extending to the outer1/3 of dentin
  • ICDAS (3) and ICDAS(4).

Exclusion Criteria:

• • Allergy to any restorative materials.

  • Patients undergoing orthodontic treatment with fixed appliances.
  • Patients with debilitating systemic diseases.
  • Children with special needs.
  • Teeth with previous restorations.
  • Periapical radiolucencies and sensitivity to axial or lateral percussion.
  • Mobile teeth.
  • External or internal resorption.
  • Cervical carious lesions.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Hall Technique; Preformed metal crown (stainless steel) placed over the carious primary molar using the Hall Technique, without caries removal or local anesthesia. A separator will be placed 48 hours prior to the procedure to create space for crown seating. The crown will be cemented with glass ionomer cement (GC Fuji I or equivalent) and seated with firm biting pressure.	Other: hall technique; the hall technique is a minimally invasive method used in paediatric dentistry to manage carious primary molars.it involves sealing the decay under e preformed stainless steel crown
Experimental: Giomer Restoration; Proximal cavity preparation using a high-speed handpiece followed by selective caries removal. Isolation with cotton rolls and sectional matrix system. Application of bioactive self-etch adhesive (BeautiBond Xtreme, Shofu) followed by incremental placement of injectable bioactive giomer composite (Beautifil Flow Plus X F00, Shofu). Each increment light-cured for 20 seconds at 1000-1200 mW/cm². Finishing and polishing performed with fine diamond burs, finishing strips, and polishing discs.	Other: giomer; restoration of proximal cavities in primary molars using an injectable bioactive composite (Giomer) material. Cavities will be prepared following minimally invasive principles, isolated appropriately, and restored according to the manufacturer's instructions using adhesive bonding. Clinical performance will be evaluated in terms of retention, marginal adaptation, secondary caries, postoperative sensitivity, and overall restoration success during the follow-up period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Restoration Survival Rate assessed by clinical and radiographic success/failure criteria (Innes et al., 2007)	1- year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FDI criteria biological	Biological properties: recurrent caries and adjacent mucosa	1- year

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: February 18, 2026
• First Submitted That Met QC Criteria: April 20, 2026
• First Posted (Actual): April 27, 2026

Study Record Updates

• Last Update Posted (Actual): April 27, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: hall technique; giomer; primary molars; proximal cavities
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth Demineralization; Dental Caries
• Other Study ID Numbers: CairoU- Hall Vs Giomer; Cairo University (Other Identifier: Cairo University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No