NCT05747183

Brief Summary

This clinical trial aims to compare the effect of Pro Taper Ultimate and Pro Taper Gold files on post-endodontic pain in molars with symptomatic apical periodontitis. The main question it aims to answer is: If there is a difference in post-endodontic pain intensity following root canal preparation using Pro Taper Ultimate and Pro Taper Gold files in molar diagnosed with symptomatic apical periodontitis? Participants will undergo root canal treatment using Pro Taper Ultimate and Pro Taper Gold files. Researchers will compare \[Pro Taper Ultimate and Pro Taper Gold files\] to see the intensity of post-endodontic pain

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

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

September 12, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 28, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

September 4, 2024

Status Verified

September 1, 2024

Enrollment Period

1.3 years

First QC Date

February 17, 2023

Last Update Submit

September 2, 2024

Conditions

Post Endodontic Pain

Keywords

Post endodontic painProTaper GoldProTaper UltimateRoot canal preparation

Outcome Measures

Primary Outcomes (3)

  • The level of post-endodontic pain

    Evaluation of the pain intensity using the Visual Analogue Scale. The Visual Analogue Scale measures pain intensity. The Visual Analogue Scale consists of a 10cm line, with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could possibly be)

    24 hours

  • The level of post-endodontic pain

    Evaluation of the pain intensity using the Visual Analogue Scale. The Visual Analogue Scale measures pain intensity. The Visual Analogue Scale consists of a 10cm line, with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could possibly be)

    72 hours

  • The level of post-endodontic pain

    Evaluation of the pain intensity using the Visual Analogue Scale. The Visual Analogue Scale measures pain intensity. The Visual Analogue Scale consists of a 10cm line, with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could possibly be)

    1 week

Study Arms (2)

ProTaper Ultimate

EXPERIMENTAL

Root canal preparation using ProTaper Ultimate files.

Procedure: ProTaper Ultimate

ProTaper Gold files

ACTIVE COMPARATOR

Root canal preparation using ProTaper Gold files.

Procedure: ProTaper Gold

Interventions

ProTaper UltimatePROCEDURE

Root canal preparation using ProTaper Ultimate files.

ProTaper Ultimate
ProTaper GoldPROCEDURE

Root canal preparation using ProTaper Gold files.

ProTaper Gold files

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient was diagnosed with symptomatic irreversible pulpits and symptomatic apical periodontitis.
  • years old patients
  • Permanent mandibular first molars.
  • Teeth with a fully matured root.
  • Restorable teeth indicated for endodontic treatment.
  • Healthy patients.

You may not qualify if:

  • Complex root canal morphology
  • Calcified roots.
  • Teeth with internal and external resorption.
  • Medically compromised patients.
  • Restricted mouth openings (trismus).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gulf Medical University

Ajman, 4184, United Arab Emirates

Location

Related Publications (1)

  • Hajwel M, Elemam R, Elsewify T, Eid B. Effect of ProTaper Ultimate and ProTaper Gold on Postoperative Pain in Mandibular First Molars With Symptomatic Irreversible Pulpitis and Symptomatic Apical Periodontitis: A Randomized Control Clinical Trial. Pain Res Manag. 2025 Oct 30;2025:9718875. doi: 10.1155/prm/9718875. eCollection 2025.

    PMID: 41211526DERIVED

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
Assistant Professor of Cell Biology and Researcher

Study Record Dates

First Submitted

February 17, 2023

First Posted

February 28, 2023

Study Start

September 12, 2022

Primary Completion

January 12, 2024

Study Completion

July 1, 2024

Last Updated

September 4, 2024

Record last verified: 2024-09

Locations

AE(1)