NCT07355920

Brief Summary

The aim of this study will be directed to: Evaluate the clinical performance of alkasite composite as a final restoration for pulpotomized primary molars.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 30, 2024

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 12, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 21, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

January 23, 2026

Status Verified

December 1, 2025

Enrollment Period

1.7 years

First QC Date

January 12, 2026

Last Update Submit

January 21, 2026

Conditions

Pediatric DentistryPost Pulpotomy Restoration

Keywords

cention fortetetric n ceramalkasite

Outcome Measures

Primary Outcomes (1)

  • Clinical evaluation of the final restoration according to USPHS Criteria

    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

Study Arms (2)

Group I: Study group :Alkasite( cention forte )

EXPERIMENTAL

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

Procedure: Cention Forte

Group II :Control group: Tetric N-Ceram

ACTIVE COMPARATOR

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

Procedure: Tetric® N-Ceram

Interventions

Cention FortePROCEDURE

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

Also known as: alkasite
Group I: Study group :Alkasite( cention forte )
Tetric® N-CeramPROCEDURE

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

Also known as: bulk-fill composite
Group II :Control group: Tetric N-Ceram

Eligibility Criteria

Age4 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Tanta, Egypt

Location

Related Publications (1)

  • Kaur K, Suneja B, Jodhka S, Saini RS, Chaturvedi S, Bavabeedu SS, Alhamoudi FH, Cicciu M, Minervini G. Comparison between Restorative Materials for Pulpotomised Deciduous Molars: A Randomized Clinical Study. Children (Basel). 2023 Feb 1;10(2):284. doi: 10.3390/children10020284.

    PMID: 36832414BACKGROUND

Study Officials

  • Faten Abu Taleb

    faculty of dentistry Tanta university

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 12, 2026

First Posted

January 21, 2026

Study Start

August 30, 2024

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

January 23, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)