Dental Caries
Conditions
Keywords
Randomized Clinical Trial, Primary Dentition, Giomer, RMGI, FDI criteria
Brief summary
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.
Detailed description
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.
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.
OTHERRMGI
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.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Blinding of operators, patients, parents and outcome assessors was not possible as both materials differ in appearance and application technique.
Eligibility
Sex/Gender
ALL
Age
3 Years to 8 Years
Healthy volunteers
No
Inclusion criteria
* Children aged 3-8 years of both genders * Cooperative behavior manageable by operators * Willing to sign informed consent * Accepts the follow-up period * Moderate to low caries risk according to Cariogram application * Posterior primary molar with proximal carious lesion (ICDAS 3 or 4) with no signs or symptoms of pulpal involvement * Radiographically extending to outer 1/3 of dentin
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 or sensitivity to percussion * Mobile teeth * External or internal resorption * Cervical carious lesions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Caries | Baseline, 3, 6, and 12 months | Assessed using revised FDI criteria (B1: caries at restoration margin). Evaluated by visual examination and short air drying. Scored on ordinal scale 1-5. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative sensitivity / pulp status | Baseline, 3, 6, and 12 months | Presence of caries at restoration margin assessed by visual examination using revised FDI criteria (B1), scored 1-5. |
| Marginal Adaptation | Baseline, 3, 6, and 12 months | Quality of marginal seal between restoration and tooth structure assessed using revised FDI criteria (F2), scored 1-5. |
| Proximal Contact Point | Baseline, 3, 6, and 12 months | Presence and quality of proximal contact between restored tooth and adjacent tooth assessed using revised FDI criteria (F3), scored 1-5 |
| Occlusal Wear | Baseline, 3, 6, and 12 months | Degree of wear of restoration surface under occlusal loading assessed using revised FDI criteria (F5), scored 1-5 |
| Fracture and Retention | Baseline, 3, 6, and 12 months | Presence of cracks, fractures, or loss of restoration assessed using revised FDI criteria (F1), scored 1-5 |
Contacts
CONTACTNadine Elsayed Ahmed Elshayal
CONTACTDina Mohamed
PRINCIPAL_INVESTIGATORNadine Elshayal
Cairo University
PRINCIPAL_INVESTIGATORDina Ez Mohamed
Cairo University
STUDY_DIRECTOROsama Elshahawy
Cairo University
Outcome results
None listed