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

May 12, 2024 updated by: Ola Yasir Abdulaziz Mahmoud, Cairo University

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: ola yasir mahmoud, master candidate
  • Phone Number: 00201062990481 00971561565339
  • Email: yasirola95@gmail.com

Study Contact Backup

  • Name: mohd ya sir, master candidate
  • Phone Number: 00201003276852 +971555304323
  • Email: moyasir1999@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Alkasite restorative material in primary molar
ARM 1 : ALKASITE RESTORATIVE MATERIAL( INTERVENTION)
Other: ALKASITE RESTORATIVE MATERIAL
Restorative material for primary teeth
Other Names:
  • cention n
Active Comparator: Glass Ionomer Cement in primary molar
ARM2: Glass Ionomer Cement(CONTROL)
Other: Glass Ionomer Cement
Restorative material for primary teeth
Other Names:
  • GIC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
recurrent caries of the tooth
Time Frame: 12 months
Radiograph &Visual inspection using Modified United States Public Health Service Ryge criteria (USPHS
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Director: Sherien Ezz Eldin, Professor, cairo university faculty of pediatric dentistry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

December 23, 2023

First Submitted That Met QC Criteria

December 23, 2023

First Posted (Actual)

January 8, 2024

Study Record Updates

Last Update Posted (Actual)

May 14, 2024

Last Update Submitted That Met QC Criteria

May 12, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • alkasite material

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

study protocol and statistical analysis

IPD Sharing Time Frame

after one year

IPD Sharing Access Criteria

with other investigator including who will work with systematic review , will provide the clinical study report with the documents above

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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