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NCT Number: NCT07355920

Use of Alkasite for Postpulpotomy Restoration

The aim of this study will be directed to:

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Pediatric Dentistry Post Pulpotomy Restoration

Age range

4 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Tanta, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Cention Forte

Procedure

25 primary molars were restored with an Alkasite composite Cention-forte after Formocresol pulpotomy.

Other names: alkasite

Tetric® N-Ceram

Procedure

5 primary molars were restored with Tetric® N-Ceram bulk-fill composite after Formocresol pulpotomy.

Other names: bulk-fill composite

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Acronym: Cention-Forte

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 21, 2026
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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