NCT06903013

Brief Summary

Study will evaluate and compare post operative pain for primary molars with irreversible pulpitis after pulpotomy and pulpuectomy

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Status
not yet 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

First Submitted

Initial submission to the registry

March 24, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 30, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

March 30, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2025

Completed
Last Updated

March 30, 2025

Status Verified

March 1, 2025

Enrollment Period

6 months

First QC Date

March 24, 2025

Last Update Submit

March 24, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Post operative pain

    Post operative pain using pain scale after 1,2,7 days

    6 months

Study Arms (2)

Pulpotomy

EXPERIMENTAL

Vital pulpotomy using regenerative materials

Other: Vital pulp therapy

Pulpectomy

ACTIVE COMPARATOR
Other: Non vitalPulp therapy

Interventions

Pulp therapy deals about management of inflamed vital dental pulp With complete pulp removal and obturation with resorbable materi

Pulpectomy

Pulp therapy through partial root removal and using of regenerative capping material

Pulpotomy

Eligibility Criteria

Age4 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Healthy individual
  • Has primary tooth with irreversible pulpitis
  • Cooperative child

You may not qualify if:

  • Mentally, physically or medically compromised children
  • Uncooperative children

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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
Lecturer

Study Record Dates

First Submitted

March 24, 2025

First Posted

March 30, 2025

Study Start

March 30, 2025

Primary Completion

September 30, 2025

Study Completion

October 30, 2025

Last Updated

March 30, 2025

Record last verified: 2025-03