Use of Alkasite for Postpulpotomy Restoration (Cention-Forte)

January 21, 2026 updated by: Manar Taha Mokhtar Hamed Elsayed, Tanta University

Clinical Evaluation of Alkasite Composite as a Final Restoration for Pulpotomized Primary Molars.

The aim of this study will be directed to:

Evaluate the clinical performance of alkasite composite as a final restoration for pulpotomized primary molars.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

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 Locations

  • Egypt
      • Tanta, Egypt
        • The clinical study was carried out at the clinic of Pediatric and Preventive Dentistry Department, Faculty of dentistry, Tanta university.

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

Yes

Description

Inclusion Criteria:

  • Deep carious vital primary molars at site 1, 2, and size 3 according to the SI/STA classification of caries.
  • Healthy children free from systemic diseases.
  • Cooperative patient: Frankel rating 3,4.

Radiographically:

  • Deep caries approximating the pulp.
  • Roots with no more than one-third physiologic resorption.
  • Normal lamina dura and periodontal ligament space.

Exclusion Criteria:

  • Patients with bruxism.
  • Clinical signs or symptoms of irreversible pulpitis or pulp degeneration.
  • Parents refuse treatment.

Radiographically:

  • Furcation involvement.
  • periapical lesion.
  • Pathologic resorption (internal or external).

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group I: Study group :Alkasite( cention forte )
25 primary molars were restored with an Alkasite composite Cention-forte after Formocresol pulpotomy.
Procedure: Cention Forte
25 primary molars were restored with an Alkasite composite Cention-forte after Formocresol pulpotomy.
Other Names:
  • alkasite
Active Comparator: Group II :Control group: Tetric N-Ceram
25 primary molars were restored with Tetric® N-Ceram bulk-fill composite after Formocresol pulpotomy.
Procedure: Tetric® N-Ceram
5 primary molars were restored with Tetric® N-Ceram bulk-fill composite after Formocresol pulpotomy.
Other Names:
  • bulk-fill composite

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical evaluation of the final restoration according to USPHS Criteria
Time Frame: at 3, 6, and 9 months
Clinical evaluation of the final restoration is done according to the modified united states public health service USPHS Criteria for direct clinical evaluation of restoration
at 3, 6, and 9 months

Collaborators and Investigators

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

Sponsor

Tanta University

Investigators

  • Study Chair: Faten Abu Taleb, faculty of dentistry Tanta university

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 (Actual)

August 30, 2024

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

January 12, 2026

First Submitted That Met QC Criteria

January 12, 2026

First Posted (Actual)

January 21, 2026

Study Record Updates

Last Update Posted (Actual)

January 23, 2026

Last Update Submitted That Met QC Criteria

January 21, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • #P-PED-6-24-2204

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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