Dental Caries, Primary Molars
Conditions
Keywords
stela, Primary molars, Pediatric dentistry, Direct restoration, Cention N, Nanohybrid composite, Resin-modified glass ionomer, FDI criteria
Brief summary
This randomized clinical trial aims to compare the clinical and radiographic performance of four direct restorative materials used for restoring carious primary molars in children. Eligible children aged 4-8 years with posterior primary molars requiring direct restoration will be randomly allocated (1:1:1:1) to receive one of the following materials: an alkasite restorative material (Cention N), a self-cure bulk-fill resin composite (Stela; SDI), a conventional light-cured nanohybrid resin composite (Beautifil II), or a resin-modified glass ionomer cement (Riva Light Cure). Restorations will be evaluated using the Fédération Dentaire Internationale (FDI) World Dental Federation criteria. Postoperative sensitivity will be assessed at 48 hours using a 0-10 visual analogue scale (VAS). Clinical and radiographic follow-up assessments will be conducted at baseline and at scheduled recall visits
Interventions
DEVICECention N
Alkasite restorative material (Cention N) used for direct restoration of carious primary molars according to the manufacturer's instructions.
DEVICEStela, SDI, Australia
Self-cure bulk-fill resin composite (Stela; SDI) used for direct restoration of carious primary molars according to the manufacturer's instructions.
Light-cured nanohybrid resin composite (Beautifil II) used for direct restoration of carious primary molars according to the manufacturer's instructions.
Resin-modified glass ionomer cement (Riva Light Cure) used for direct restoration of carious primary molars according to the manufacturer's instructions.
Sponsors
Al-Azhar University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessment was performed by a blinded assessor who was unaware of group allocation; operator blinding was not feasible due to differences in material handling.
Intervention model description
Four-arm, parallel-group randomized clinical trial (1:1:1:1).
Eligibility
Sex/Gender
ALL
Age
4 Years to 8 Years
Healthy volunteers
No
Inclusion criteria
1. Age 4-8 years old. 2. Primary molars indicated for restorative treatment. 3. No pulp involvement or history of dental pain. 4. Cooperative children (Frankl: +ve or ++ve).
Exclusion criteria
1. Pulp exposure after caries removal or clinical signs of irreversible pulpitis/necrosis. 2. Severe developmental enamel defects or insufficient enamel for bonding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Restoration success based on FDI criteria (clinical and radiographic evaluation) | 6 months |
Contacts
CONTACTHosam Hassan Metwalli
Outcome results
None listed