NCT06227390

Brief Summary

the goal of this clinical trial is to compare clinical and radiographic outcomes of partial pulpotomy in vital primary molars using TheraCal PT®, Biodentin® and NeoPUTTY® MTA , followed by glass ionomer restoration only or glass ionomer restoration and stainless-steel crown.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

October 15, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 26, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 27, 2025

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2025

Completed
Last Updated

November 24, 2025

Status Verified

January 1, 2024

Enrollment Period

1.9 years

First QC Date

December 22, 2023

Last Update Submit

November 19, 2025

Conditions

Pulp Disease, Dental

Keywords

partial pulpotomy

Outcome Measures

Primary Outcomes (1)

  • Evaluate and Compare clinical outcomes of TheraCal PT®, Biodentin® and NeoPUTTY®, followed by glass ionomer restoration only or glass ionomer restoration and stainless-steel crown.in partial pulpotomy in vital primary molars

    method of measurement: presence or absence of pain, swelling, fistula, mobility unit of measurement: yes or no

    1 year

Secondary Outcomes (1)

  • Evaluate and compare Radiographic outcomes of TheraCal PT®, Biodentin® and NeoPUTTY® MTA, followed by glass ionomer restoration only or glass ionomer restoration and stainless-steel crown in partial pulpotomy in vital primary molars

    1year

Study Arms (6)

MTA and stainless-steel crown

EXPERIMENTAL
Procedure: partial pulpotomy

Biodentine® and stainless-steel crown

EXPERIMENTAL
Procedure: partial pulpotomy

TheraCal PT® and stainless-steel crown

EXPERIMENTAL
Procedure: partial pulpotomy

MTA and glass ionomer restoration

EXPERIMENTAL
Procedure: partial pulpotomy

Biodentine® and glass ionomer restoration

EXPERIMENTAL
Procedure: partial pulpotomy

TheraCal PT® and glass ionomer

EXPERIMENTAL
Procedure: partial pulpotomy

Interventions

partial pulpotomyPROCEDURE

2-3 mm of the coronal pulp tissue is removed leaving healthy vital pulp tissue that is dressed with a dental biomaterial that maintains pulpal vitality and promotes repair

Biodentine® and glass ionomer restorationBiodentine® and stainless-steel crownMTA and glass ionomer restorationMTA and stainless-steel crownTheraCal PT® and glass ionomerTheraCal PT® and stainless-steel crown

Eligibility Criteria

Age4 Years - 7 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy patients aged 4-7-years old.
  • Cooperative patients (Frankle scale + and ++)
  • Asymptomatic primary molar with deep caries requiring vital pulp therapy

You may not qualify if:

  • presence of any of the following:
  • History of spontaneous lingering pain, swelling, or sinus tract.
  • Pathological mobility.
  • pain on percussion.
  • Furcation or periapical radiolucency.
  • pathological root resorption

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the British University in Egypt

Cairo, Egypt

Location

MeSH Terms

Conditions

Dental Pulp Diseases

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
demonstrator

Study Record Dates

First Submitted

December 22, 2023

First Posted

January 26, 2024

Study Start

October 15, 2023

Primary Completion

August 27, 2025

Study Completion

August 31, 2025

Last Updated

November 24, 2025

Record last verified: 2024-01

Locations

EG(1)