Clinical Performance of Four Restorative Materials in Primary Molars
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cention N, Stela, SDI, Australia, Beautifil II, Shofu, Japan, Resin modified glass ionomer cement.
- Who it may be relevant to
- Registry conditions: Dental Caries, Primary Molars. Basic parameters: 4 years — 8 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Clinical Evaluation of an Alkasite Restoration Material (Cention N) and Self-cure Composite (Stela; SDI) Compared to Conventional Composite and Resin-modified Glass Ionomer in Primary Molars: A Randomized Clinical Trial
Overview
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
- Device Cention N
Alkasite restorative material (Cention N) used for direct restoration of carious primary molars according to the manufacturer's instructions. - Device Stela, SDI, Australia
Self-cure bulk-fill resin composite (Stela; SDI) used for direct restoration of carious primary molars according to the manufacturer's instructions. - Device Beautifil II, Shofu, Japan
Light-cured nanohybrid resin composite (Beautifil II) used for direct restoration of carious primary molars according to the manufacturer's instructions. - Device Resin modified glass ionomer cement
Resin-modified glass ionomer cement (Riva Light Cure) used for direct restoration of carious primary molars according to the manufacturer's instructions.
Primary outcome measures
- Restoration success based on FDI criteria (clinical and radiographic evaluation) [Time frame: 6 months]
- Restoration success based on FDI criteria (clinical and radiographic evaluation) [Time frame: 6 months]
Eligibility criteria
Inclusion criteria
- Age 4-8 years old.
- Primary molars indicated for restorative treatment.
- No pulp involvement or history of dental pain.
- Cooperative children (Frankl: +ve or ++ve).
Exclusion criteria
- Pulp exposure after caries removal or clinical signs of irreversible pulpitis/necrosis.
- Severe developmental enamel defects or insufficient enamel for bonding.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07504393 · AAU-PEDO-1394-5575