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This randomized clinical trial aims to evaluate and compare the clinical performance of injectable bioactive composite (Beautifil Flow Plus X, Shofu) versus Resin Modified Glass Ionomer (RMGI) in restoring proximal cavities (Class II) in primary molars of children aged 3-8 years over a 12-month follow-up period, using revised FDI criteria.
Dental caries remains the most prevalent chronic disease in children. The choice of restorative material for primary teeth significantly impacts treatment outcomes and longevity. This study compares two fluoride-releasing restorative materials in proximal cavities of primary molars.
Eligible children aged 3-8 years with ICDAS 3 or 4 proximal carious lesions in primary molars will be randomly allocated into two equal groups (24 teeth each):
Group I (Intervention): Restoration with injectable bioactive giomer (Beautifil Flow Plus X F00, Shofu) using BeautiBond Xtreme adhesive Group II (Control): Restoration with Resin Modified Glass Ionomer (RMGI)
Restorations will be clinically evaluated at baseline, 3, 6, and 12 months using revised FDI criteria assessing biological properties (secondary caries, sensitivity, tooth integrity), functional properties (marginal adaptation, proximal contact, occlusal wear, fracture/retention), and aesthetic properties.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RMGIC | Active Comparator | cavity restorations in primary molars using a resin-modified glass ionomer cement. Following standard cavity preparation, the RMGI material will be placed according to the manufacturer's instructions. Clinical performance will be evaluated over the follow-up period in terms of restoration retention, marginal adaptation, secondary caries, postoperative sensitivity, and overall clinical success. |
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| giomer | Experimental | 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. |
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| 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 |
|---|---|---|
| Secondary Caries | Assessed using revised FDI criteria (B1: caries at restoration margin). Evaluated by visual examination and short air drying. Scored on ordinal scale 1-5. | Baseline, 3, 6, and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative sensitivity / pulp status | Presence of caries at restoration margin assessed by visual examination using revised FDI criteria (B1), scored 1-5. | Baseline, 3, 6, and 12 months |
| Marginal Adaptation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nadine Elsayed Ahmed Elshayal | Contact | 01069995861 | nadine.elshayal@dentistry.cu.edu.eg | |
| Dina Mohamed | Contact | dina.ezz@dentistry.cu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Nadine Elshayal | Cairo University | Principal Investigator |
| Dina Ez Mohamed | Cairo University | Principal Investigator |
| Osama Elshahawy |
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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Blinding of operators, patients, parents and outcome assessors was not possible as both materials differ in appearance and application technique.
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| RMGI | Other | Resin-Modified Glass Ionomer (RMGI) is a fluoride-releasing restorative material used for the restoration of carious primary teeth. It combines the properties of conventional glass ionomer cement with resin components to improve mechanical strength, adhesion, and moisture tolerance. In this study, RMGI will be used for restoring cavitated carious lesions in primary teeth following caries removal according to minimally invasive dentistry principles. |
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Quality of marginal seal between restoration and tooth structure assessed using revised FDI criteria (F2), scored 1-5.
| Baseline, 3, 6, and 12 months |
| Proximal Contact Point | Presence and quality of proximal contact between restored tooth and adjacent tooth assessed using revised FDI criteria (F3), scored 1-5 | Baseline, 3, 6, and 12 months |
| Occlusal Wear | Degree of wear of restoration surface under occlusal loading assessed using revised FDI criteria (F5), scored 1-5 | Baseline, 3, 6, and 12 months |
| Fracture and Retention | Presence of cracks, fractures, or loss of restoration assessed using revised FDI criteria (F1), scored 1-5 | Baseline, 3, 6, and 12 months |
| Cairo University |
| Study Director |