Clinical Performance of Alkasite-based Restorations in Children

Cairo University (CU)

Status: Not yet enrolling

Conditions: Alkasite-based Restorations; Nano-hybrid Resin Composite

Treatments: Other: Alkasite-based composite restorations; Other: Nano-hybrid resin composite

Study type: Interventional

Funder types: Other

Identifiers

NCT07263555

Alkasite filling and caries

Details and patient eligibility

About

The aim of this study is to evaluate and compare the clinical performance of alkasite-based resin and nanohybrid composite resin materials in the restoration of occlusal carious lesions in primary molars of children.

Full description

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 4 to 6 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

50 participants in 2 patient groups

Alkasite-based Restorations (Cention N)

Experimental group

Description:

The children assigned to this intervention group will have alkasite-based restorations for the treatment of Class I carious lesion in primary molars.

Treatment:

Other: Alkasite-based composite restorations

Nano-hybrid composite resin restoration (TPH Spectra ST Universal Composite).

Active Comparator group

Description:

The children assigned to the comparator group will undergo class I cavity restorations using nano-hybrid resin composite

Treatment:

Other: Nano-hybrid resin composite