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

Not Applicable

Not yet recruiting

• Conditions: Tooth Decay
• Interventions: Other: ALKASITE RESTORATIVE MATERIAL; Other: Glass Ionomer Cement

• Registration Number: NCT06195449
• Lead Sponsor: Cairo University

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 Timeline

• Study First Submitted: 2023-12-23
• Study First Submitted QC: 2023-12-23
• Study First Posted: 2024-01-08
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-12
• Last Update Posted: 2024-05-14
• Study Start: 2024-06-01
• Primary Completion: 2024-10-01
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• 1. Children having carious primary molars without pulp exposure and normal radiograph.

  2. Children between age 5 and 7 years. 3. Both male and female are included. 4. Cooperative Children.

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Exclusion Criteria

• 1. Patients with systemic diseases. 2. Parent refuse to participate.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Alkasite restorative material in primary molar	ALKASITE RESTORATIVE MATERIAL	ARM 1 : ALKASITE RESTORATIVE MATERIAL( INTERVENTION)
Glass Ionomer Cement in primary molar	Glass Ionomer Cement	ARM2: Glass Ionomer Cement(CONTROL)

Primary Outcome Measures

Name	Time	Method
recurrent caries of the tooth	12 months	Radiograph \&Visual inspection using Modified United States Public Health Service Ryge criteria (USPHS

Secondary Outcome Measures

Name	Time	Method
Anatomic Form of the tooth	12 months	by Visual Inspection and Explorer using Modified United States Public Health Service Ryge criteria (USPHS)
Color match of the restoration	12 months	Visual Inspection using Modified United States Public Health Service Ryge criteria (USPHS)
Marginal Discoloration of the tooth	12 months	by Visual Inspection using Modified United States Public Health Service Ryge criteria (USPHS)
Marginal Adaptation of the tooth	12 months	by Visual Inspection and Explorer using Modified United States Public Health Service Ryge criteria (USPHS)