Clinical Performance of Alkasite-based Restorations in Children

NCT07263555 | Not Yet Recruiting

• 1 other identifier: Alkasite filling and caries
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Alkasite-based Restorations; Nano-hybrid Resin Composite

Keywords

Alkasite-based Restorations; Cention N; Nano-hybrid resin composite; clinical performance; secordary caries; Children; Class I

Outcome Measures

Primary Outcomes (1)

• Incidence of secondary caries

  The primary outcome of this study will be the evaluation of secondary caries incidence at 3, 6, and 12 months following restoration. Assessment will be carried out using the United States Public Health Service (USPHS) criteria, with restorations scored on a scale ranging from Alpha (clinically excellent) to Delta (clinically unacceptable. Each restoration will be scored as Alpha (A) if there is no evidence of secondary caries and the tooth-restoration interface remains intact. A score of Bravo (B) will indicate a questionable or suspicious area, such as slight marginal staining without definite cavitation. Charlie (C) will be assigned when definite secondary caries are observed, including softness or cavitation at the restoration margin, necessitating replacement of the restoration. Delta (D) will be used for severe carious lesions extending beneath the restoration, requiring immediate intervention.

  12 months

Secondary Outcomes (1)

• clinical evaluation of restoration fracture

  12 months

Study Arms (2)

Alkasite-based Restorations (Cention N)

EXPERIMENTAL

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

Other: Alkasite-based composite restorations

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

ACTIVE COMPARATOR

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

Other: Nano-hybrid resin composite

Interventions

Alkasite-based composite restorations OTHER

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

Also known as: Cention N

Alkasite-based Restorations (Cention N)

Nano-hybrid resin composite OTHER

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

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

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Cairo Governorate, Egypt

Location

Related Publications (2)

• 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.

  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.

  PMID: 35439879 RESULT

Central Study Contacts

Yusra Hashim Khogali, Bachelor's degree in dentistry

CONTACT

+1(438)8766528; Yusra.kheir@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The children, outcome assessors, and the statistician will be blinded to the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master's degree student

Model Details: The included children with class I cavity carious lesions will be assigned to either alkasite-based restoration (Intervention group) or Nano-hybrid resin composite (Comparison group)

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 4, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: December 4, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)