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

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.

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Key information

Conditions

Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

3 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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

Primary outcomes

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

Time frame: 1- year

Secondary outcomes

FDI criteria biological

Time frame: 1- year

Biological properties: recurrent caries and adjacent mucosa

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Apr 27, 2026
Registry last updated: Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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