Clinical Performance of Alkasite-based Restorations in Children (Restorations)

Clinical Performance of Alkasite-Based Resin Versus Nanohybrid Composite Resin Restorations for Occlusal Carious Lesions in Primary Molars: A Randomized Clinical Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Alkasite-based Restorations; Nano-hybrid Resin Composite
• Intervention / Treatment: Other: Alkasite-based composite restorations; Other: Nano-hybrid resin composite

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yusra Hashim Khogali, Bachelor's degree in dentistry; Phone Number: +1(438)8766528; Email: Yusra.kheir@dentistry.cu.edu.eg

Study Locations

• Egypt
  • Cairo Governorate
    • Cairo, Cairo Governorate, Egypt
      • Cairo university
      • Contact: Manal Ahmed Elsayed, Dectorate degree
      • Contact: Rana Tarek Bartaw, Master's degree

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Alkasite-based composite restorations; Alkasite-based restorations will be used in the treatment of class I carious lesion in primary molars.; Other Names: Cention N
Active Comparator: 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	Other: Nano-hybrid resin composite; Nanohybrid composite will be used in the restoration of Class I carious lesions in primary molars.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical evaluation of restoration fracture	The secondary outcomes will include the clinical evaluation of restoration fracture at 3, 6, and 12 months. The occurrence of restoration fracture will be evaluated using the United States Public Health Service (USPHS) criteria. Each restoration will be scored as Alpha (A) if no fracture is present and the restoration remains intact. A score of Bravo (B) will indicate minor chipping or superficial fracture that does not compromise function. Charlie (C) will be assigned when a fracture is evident that affects the integrity or function of the restoration, necessitating repair or replacement. Delta (D) will be used for severe fracture resulting in complete loss of the restoration, requiring immediate replacement.	12 months

Collaborators and Investigators

• Sponsor: Cairo University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: December 3, 2025
• First Posted (Estimated): December 4, 2025

Study Record Updates

• Last Update Posted (Estimated): December 4, 2025
• Last Update Submitted That Met QC Criteria: December 3, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Children; clinical performance; Cention N; Alkasite-based Restorations; Nano-hybrid resin composite; secordary caries; Class I
• Other Study ID Numbers: Alkasite filling and caries

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Not determined yet.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No