Clinical and Radiographic Evaluation of Alkasite Restorative Material Versus Glass Ionomer Cement in Restoration of Primary Molars: Randomized Clinical Trial.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Cairo University
- 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
ARM 1 : ALKASITE RESTORATIVE MATERIAL( INTERVENTION)
Intervention: ALKASITE RESTORATIVE MATERIAL (Other)
Glass Ionomer Cement in primary molar
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
Ola Yasir Abdulaziz Mahmoud
principal investigator
Cairo University
