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Not yet recruiting NCT07263555

Clinical Performance of Alkasite-based Restorations in Children

No phase Interventional Alkasite-based Restorations Nano-hybrid Resin Composite

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Alkasite-based composite restorations, Nano-hybrid resin composite.
Who it may be relevant to
Registry conditions: Alkasite-based Restorations, Nano-hybrid Resin Composite. Basic parameters: 4 years — 6 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Other Alkasite-based composite restorations
    Alkasite-based restorations will be used in the treatment of class I carious lesion in primary molars.
  • Other Nano-hybrid resin composite
    Nanohybrid composite will be used in the restoration of Class I carious lesions in primary molars.

Primary outcome measures

  • Incidence of secondary caries [Time frame: 12 months]
Secondary outcome measures (1)
  • clinical evaluation of restoration fracture [Time frame: 12 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Cairo University — Cairo

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. PMID 35439879

Identifiers

NCT: NCT07263555 · Alkasite filling and caries

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗