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Clinical Trials/NCT06195449
NCT06195449CompletedNot Applicable

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

Cairo University1 site in 1 country24 target enrollmentStarted: April 1, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
24
Locations
1
Primary Endpoint
recurrent caries of the tooth

Study Overview

Brief Summary

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

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Masking Description

Statistician

Eligibility Criteria

Ages
5 Years to 7 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Alkasite restorative material in primary molar

Experimental

ARM 1 : ALKASITE RESTORATIVE MATERIAL( INTERVENTION)

Intervention: ALKASITE RESTORATIVE MATERIAL (Other)

Glass Ionomer Cement in primary molar

Active Comparator

ARM2: Glass Ionomer Cement(CONTROL)

Intervention: Glass Ionomer Cement (Other)

Outcomes

Primary Outcomes

recurrent caries of the tooth

Time Frame: 12 months

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

Secondary Outcomes

  • Anatomic Form of the tooth(12 months)
  • Color match of the restoration(12 months)
  • Marginal Adaptation of the tooth(12 months)
  • Marginal Discoloration of the tooth(12 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ola Yasir Abdulaziz Mahmoud

principal investigator

Cairo University

Study Sites (1)

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