Injectable Bioactive Composite vs Hall Technique for Proximal Cavities in Primary Molars
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: giomer, hall technique.
- Who it may be relevant to
- Registry conditions: Dental Caries. Basic parameters: 3 years — 8 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Clinical Evaluation of Injectable Bioactive Composites vs Hall Technique for Restoring Proximal Cavities in Primary Molars: A Randomized Clinical Trial
Overview
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.
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.
Interventions
- 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. - 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
Primary outcome measures
- Restoration Survival Rate assessed by clinical and radiographic success/failure criteria (Innes et al., 2007) [Time frame: 1- year]
Secondary outcome measures (1)
- FDI criteria biological [Time frame: 1- year]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07552129 · CairoU- Hall Vs Giomer · Cairo University