Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| Cairo University | Other Identifier | Cairo University |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Restoration Survival Rate assessed by clinical and radiographic success/failure criteria (Innes et al., 2007) | 1- year |
| Measure | Description | Time Frame |
|---|---|---|
| FDI criteria biological | Biological properties: recurrent caries and adjacent mucosa | 1- year |
Not provided
Inclusion Criteria:
• Generally showing cooperative behaviour that could be managed by the operators.
Exclusion Criteria:
• Allergy to any restorative materials.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
|
| 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 |
|