Post Operative Pain Following Pulpectomy Versus Pulpotomy... | NCT06903013

Studies
Post Operative Pain Following Pulpectomy Versus Pulpotomy in Primary Molars Wit Irreversible Pulpitis

NCT06903013

Sponsor

Minia University

Status

Not yet recruiting

Last Update Posted

Mar 30, 2025Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Irreversible Pulpitis

Interventions

Non vitalPulp therapy
Vital pulp therapy

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 30, 2025Estimated

Primary Completion Date

Sep 30, 2025Estimated

Completion Date

Oct 30, 2025Estimated

First Submitted Date

Mar 24, 2025

First Submission Date that Met QC Criteria

Mar 24, 2025

First Posted Date

Mar 30, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 24, 2025

Last Update Posted Date

Mar 30, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pulpotomy	Experimental	Vital pulpotomy using regenerative materials	Other: Vital pulp therapy
Pulpectomy	Active Comparator		Other: Non vitalPulp therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Non vitalPulp therapy	Other	Pulp therapy deals about management of inflamed vital dental pulp With complete pulp removal and obturation with resorbable materi	Pulpectomy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Post operative pain	Post operative pain using pain scale after 1,2,7 days	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy individual
Has primary tooth with irreversible pulpitis
Cooperative child

Exclusion Criteria:

Mentally, physically or medically compromised children
Uncooperative children

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

10 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided