Clinical Performance of Alkasite-based Restorations in Children

NCT ID: NCT07263555

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-01
• Study Completion Date: 2027-02-28

Brief Summary

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.

Detailed 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.

Conditions

Alkasite-based Restorations; Nano-hybrid Resin Composite

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Alkasite-based Restorations (Cention N)

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

Group Type: EXPERIMENTAL

Alkasite-based composite restorations

Intervention Type: OTHER

Alkasite-based restorations will be used in the treatment of class I carious lesion in primary molars.

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

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

Group Type: ACTIVE_COMPARATOR

Nano-hybrid resin composite

Intervention Type: OTHER

Nanohybrid composite will be used in the restoration of Class I carious lesions in primary molars.

Interventions

Alkasite-based composite restorations

Alkasite-based restorations will be used in the treatment of class I carious lesion in primary molars.

Intervention Type: OTHER

Nano-hybrid resin composite

Nanohybrid composite will be used in the restoration of Class I carious lesions in primary molars.

Intervention Type: OTHER

Other Intervention Names

Cention N

Eligibility 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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Yusra hashim Mohamed kheir khogali

Master's degree student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cairo University

Cairo, Cairo Governorate, Egypt

Countries

Egypt

Central Contacts

Yusra Hashim Khogali, Bachelor's degree in dentistry

Role: CONTACT

Yusra.kheir@dentistry.cu.edu.eg

+1(438)8766528

Facility Contacts

Manal Ahmed Elsayed, Dectorate degree

Role: primary

Rana Tarek Bartaw, Master's degree

Role: backup

References

Attia, R., Sabry, R., Elafefy, A., & Essa, M. (2022). Clinical Performance of Alkasite Dental Material and High Viscosity Glass Ionomer Restorations in Class I Cavities. Comparative Study for One Year Follow Up. Egyptian Dental Journal, 68(4), 3881-3894.

Reference Type: BACKGROUND

Arora D, Jain M, Suma Sogi HP, Shahi P, Gupta I, Sandhu M. In vivo evaluation of clinical performance of Cention N and glass ionomer cement in proximal restorations of primary molars. J Indian Soc Pedod Prev Dent. 2022 Jan-Mar;40(1):23-29. doi: 10.4103/jisppd.jisppd_108_21.

Reference Type: RESULT

PMID: 35439879 (View on PubMed)

Other Identifiers

Alkasite filling and caries

Identifier Type: -

Identifier Source: org_study_id