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

NCT07552129 | Not Yet Recruiting DMC

• 2 other identifiers: CairoU- Hall Vs GiomerCairo University
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Dental Caries

Keywords

hall technique; giomer; primary molars; proximal cavities

Outcome Measures

Primary Outcomes (1)

• Restoration Survival Rate assessed by clinical and radiographic success/failure criteria (Innes et al., 2007)

  1- year

Secondary Outcomes (1)

• FDI criteria biological

  1- year

Study Arms (2)

Hall Technique

ACTIVE COMPARATOR

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

Giomer Restoration

EXPERIMENTAL

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

Interventions

giomer OTHER

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.

Giomer Restoration

hall technique OTHER

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

Hall Technique

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Blinding was not possible for any party (participant, care provider, investigator, or outcomes assessor), as the Hall Technique crown and the giomer restoration are visually distinct and easily identifiable.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 18, 2026
• First Posted: April 27, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share