Clinical Evaluation of Injectable Bioactive Composites Versus Resin Modified Glass Ionomer for Restoring Proximal Cavities in Primary Molars: A Randomized Clinical Tria
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Cairo University
- Enrollment
- 50
- Primary Endpoint
- Secondary Caries
Overview
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.
Study Design
- Study Type
- Interventional
- 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 Criteria
- Ages
- 3 Years to 8 Years (Child)
- Sex
- All
- Accepts 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
Arms & Interventions
RMGIC
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.
Intervention: giomer (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.
Intervention: RMGI (Other)
Outcomes
Primary Outcomes
Secondary Caries
Time Frame: 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 Outcomes
- Postoperative sensitivity / pulp status(Baseline, 3, 6, and 12 months)
- Marginal Adaptation(Baseline, 3, 6, and 12 months)
- Proximal Contact Point(Baseline, 3, 6, and 12 months)
- Occlusal Wear(Baseline, 3, 6, and 12 months)
- Fracture and Retention(Baseline, 3, 6, and 12 months)
Investigators
Nadine elsayed Elshayal
Master's Student
Cairo University