Clinical Performance of Alkasite-based Restorations in Children

This randomized clinical trial aims to evaluate and compare the clinical performance of an alkasite-based resin restorative material (Cention N®) and a nanohybrid composite resin (TPH Spectra ST Universal Composite) in restoring occlusal carious lesions (Class I) in primary molars among children aged 4-6 years. Participants will be randomly allocated in a 1:1 ratio into two parallel groups and followed for a period of 12 months. The primary outcome will be the incidence of secondary caries assessed at 3, 6, and 12 months using the United States Public Health Service (USPHS) criteria, which grades restorations from Alpha (ideal/excellent) to Delta (failure). Secondary outcomes will include the evaluation of restoration fracture, marginal adaptation, marginal discoloration, surface roughness, and retention, all assessed at the same intervals using the same USPHS criteria.

Inclusion criteria

• • Children aged 4-6 years of both sexes.

• Cooperative children.
• Apparently medically fit children according to parental history.
• Children whose parents agree to sign the informed consent.
• Children whose parents will be able to attend the follow-up.

Teeth:

• Primary molars with occlusal carious lesions (Class I), indicated for direct restorations.
• Teeth without signs of pulpal involvement, abscess, or fractures.

Exclusion criteria

Children:

• Children with systemic or mental disorders.
• Children whose parents refused to sign the informed consent.
• Noncompliant parent.
• Uncooperative children.

Teeth:

• Teeth with deep caries involving the pulp or clinical signs of pulpal infection (e.g., swelling, sinus, fistula, pathological mobility).
• Teeth with periapical pathology, internal or external root resorption, or mobility.
• Non-restorable teeth or lacking sufficient structure for restoration