Dental Caries
Conditions
Keywords
hall technique, giomer, primary molars, proximal cavities
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.
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
OTHERgiomer
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.
OTHERhall 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
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
3 Years to 8 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Restoration Survival Rate assessed by clinical and radiographic success/failure criteria (Innes et al., 2007) | 1- year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| FDI criteria biological | 1- year | Biological properties: recurrent caries and adjacent mucosa |
Outcome results
None listed