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Completed

NCT Number: NCT06195449

Clinical and Radiographic Evaluation of Alkasite Restorative Material Versus Glass Ionomer Cement

To evaluate the clinical and radiographic performance of Alkasite restorative material versus glass ionomer in restoration of primary molars.

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Key information

Age range

5 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University dental hospital

Cairo, Cairo Governorate, Egypt

About this study

Restorations replacements are mostly caused by the existence of caries lesions surrounding the restorations, which are commonly referred to as secondary caries .

Secondary or recurrent caries is characterized as "lesions that occur at the edges of previously placed dental restorations" or "caries that develop in association with dental restorations or sealants" (CARS).Proper seal at the tooth surface restoration interface is essential . That's why the most frequently material used is (GIC) with the advantage of chemical adhesion to tooth structure, superior esthetics, and long-term fluoride release providing cariostatic effect, but it has the disadvantage of slow setting rate, low fracture toughness, susceptibility to moisture contamination, dehydration during initial phase of setting, and poor wear resistance.

Resin Modified Glass Ionomer and Composite have always been the preferred material for restoration although several modifications have been made recently to improve its properties, Cent ion N is one of the recent ones.

Cent ion N is a tooth-colored basic filling material for direct restoration. It belongs to the material of Alka sites, with high flexural strength. It also has calcium and fluoride releasing properties comparable to conventional GIC, besides it is quick and easy to use.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children having carious primary molars without pulp exposure and normal radiograph.
  • Children between age 5 and 7 years.
  • Both male and female are included.
  • Cooperative Children.

Exclusion criteria

  • Patients with systemic diseases.
  • Parent refuse to participate.

Treatment and study plan

ALKASITE RESTORATIVE MATERIAL

Other

Restorative material for primary teeth

Other names: cention n

Glass ionomer cement

Other

Restorative material for primary teeth

Other names: GIC

Primary outcomes

  1. recurrent caries of the tooth

    Time frame: 12 months

    Radiograph &Visual inspection using Modified United States Public Health Service Ryge criteria (USPHS

Secondary outcomes

  1. Color match of the restoration

    Time frame: 12 months

    Visual Inspection using Modified United States Public Health Service Ryge criteria (USPHS)

  2. Marginal Discoloration of the tooth

    Time frame: 12 months

    by Visual Inspection using Modified United States Public Health Service Ryge criteria (USPHS)

  3. Marginal Adaptation of the tooth

    Time frame: 12 months

    by Visual Inspection and Explorer using Modified United States Public Health Service Ryge criteria (USPHS)

  4. Anatomic Form of the tooth

    Time frame: 12 months

    by Visual Inspection and Explorer using Modified United States Public Health Service Ryge criteria (USPHS)

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Clinical and Radiographic Evaluation of Alkasite Restorative Material Versus Glass Ionomer Cement in Restoration of Primary Molars: Randomized Clinical Trial.

Acronym: GIC

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 8, 2024
Registry last updated
Aug 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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