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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06195449
Acronym
GIC
Enrollment
24
Registered
2024-01-08
Start date
2024-06-01
Completion date
2024-12-31
Last updated
2024-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tooth Decay

Keywords

Alkasite restorative material, cention N, GIC, Primary molars

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.

Interventions

OTHERALKASITE RESTORATIVE MATERIAL

Restorative material for primary teeth

Restorative material for primary teeth

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Statistician

Eligibility

Sex/Gender
ALL
Age
5 Years to 7 Years
Healthy volunteers
No

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.

Exclusion criteria

* 1\. Patients with systemic diseases. 2. Parent refuse to participate.

Design outcomes

Primary

MeasureTime frameDescription
recurrent caries of the tooth12 monthsRadiograph &Visual inspection using Modified United States Public Health Service Ryge criteria (USPHS

Secondary

MeasureTime frameDescription
Color match of the restoration12 monthsVisual Inspection using Modified United States Public Health Service Ryge criteria (USPHS)
Marginal Discoloration of the tooth12 monthsby Visual Inspection using Modified United States Public Health Service Ryge criteria (USPHS)
Marginal Adaptation of the tooth12 monthsby Visual Inspection and Explorer using Modified United States Public Health Service Ryge criteria (USPHS)
Anatomic Form of the tooth12 monthsby Visual Inspection and Explorer using Modified United States Public Health Service Ryge criteria (USPHS)

Contacts

Primary Contactola yasir mahmoud, master candidate
yasirola95@gmail.com00971561565339
Backup Contactmohd ya sir, master candidate
moyasir1999@gmail.com+971555304323

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026