NCT05057325

Brief Summary

Evaluation of post operative pain after pulpectomy procedures for primary molars with irreversible pulp damage and without periapical radulicency using two different systems (One shape file ( ratation movemont) and wave one gold file ( reciprocation movement)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
164

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2021

Shorter than P25 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

January 10, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2021

Completed
28 days until next milestone

First Posted

Study publicly available on registry

September 27, 2021

Completed
Last Updated

September 27, 2021

Status Verified

August 1, 2021

Enrollment Period

4 months

First QC Date

August 30, 2021

Last Update Submit

September 15, 2021

Conditions

Pulp Necroses

Outcome Measures

Primary Outcomes (1)

  • Post operative pain

    Assessment of pain using 4 piont intensity scale 1 means no pain, 2 means slight pain, 3 means moderate pain and for means sever pain at 6,12, 48,72 hours and 1 week

    1 week

Study Arms (2)

Wave One Gold

EXPERIMENTAL

Receporcating single file used for preparation of root canals in primary molars

Other: Pulpectomy using single file system ( WaveOne Gold file)

One shape

EXPERIMENTAL

Rotation single file used for preparation of root canals in primary molars

Other: Pulpectomy using single file system ( One Shape file)

Interventions

Pulpectomy using single file system ( One Shape file)OTHER

Rotary file instrument for pulpectomy of primary molars ( One shape file)

One shape
Pulpectomy using single file system ( WaveOne Gold file)OTHER

Rotary file instrument for pulpectomy of primary molars ( WaveOne Gold file)

Wave One Gold

Eligibility Criteria

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

You may qualify if:

  • Age of more than 4 years
  • Healthy children
  • Primary molars with irreversible pulp damage

You may not qualify if:

  • Presence of periapical radiolucency realtes to primary molar
  • Uncooperative child

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minia University

Minya, 61111, Egypt

Location

MeSH Terms

Conditions

Dental Pulp Necrosis

Condition Hierarchy (Ancestors)

Dental Pulp DiseasesTooth DiseasesStomatognathic DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

August 30, 2021

First Posted

September 27, 2021

Study Start

January 10, 2021

Primary Completion

May 10, 2021

Study Completion

June 10, 2021

Last Updated

September 27, 2021

Record last verified: 2021-08

Locations

EG(1)