NCT06573710

Brief Summary

The aim of this clinical trial is : To evaluate effect of different techniques of irrigant activation:

  1. 1.LASER activation
  2. 2.sonic activation
  3. 3.ultrasonic activation
  4. 4.passive needle irrigation
  5. 5.Postoperative pain in vital teeth (Randomized controlled trial)
  6. 6.Amount of apical extrusion (In vitro study) Participants will describe their preoperative pain and postoperative pain level at fixed time interval Research will compare postoperative pain accompanied with different irrigant activation techniques and correlate it to amount of debris extrusion

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 27, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

August 27, 2024

Status Verified

August 1, 2024

Enrollment Period

8 months

First QC Date

August 24, 2024

Last Update Submit

August 24, 2024

Conditions

Keywords

irrigant , ultrasonic, LASER , sonic

Outcome Measures

Primary Outcomes (1)

  • Evaluation of postoperative pain

    visual analogue scale

    8,24,48 hours and one week

Secondary Outcomes (1)

  • Frequency of analgesic intake

    8,24,48 hours and one week

Study Arms (4)

Sonic activation

EXPERIMENTAL
Device: sonic activator

LASER activation

EXPERIMENTAL
Device: LASER activation

Ultrasonic activation

EXPERIMENTAL
Device: Ultrasonic activation

passive irrigation with Endodontic needle

ACTIVE COMPARATOR
Device: passive irrigation with Endodontic needle

Interventions

Polyamide EDDY tips 28mm long is inserted in the canal 2mm short of the working length operated at 6,000 Hz. Activation is done for three cycles each for 20sec. The tip is moved vertically in up and down motion, 1ml is used for each activation cycle followed by 2ml 17% EDTA20

Sonic activation

Diode laser 980nm is used to activate the irrigant using fiber optic tip of (200micrometer) and power of 1.5w continuous mode. The tip is placed 2 mm shorter than the working length. Laser irradiation is done for each canal for 20 secs repeated over three cycles for total time of 60 secs and 10 secs pauses between each cycle

LASER activation

ED60tip is used with ultrasonic device operated on mode E and inserted in the canal 2mm short of the working. Activation is done for three cycles each for 20 sec. The tip is moved vertically in up and down motion,1ml is used for each activation cycle followed by 2ml 17% EDTA

Ultrasonic activation

Each canal is irrigated with side vented endodontic needle 30G Placed 2mm short of the working length with total time of 60 secs followed by 2ml 17% EDTA

passive irrigation with Endodontic needle

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age group 18-50 years
  • Males and females
  • Lower molars with symptomatic irreversible pulpitis without apical periodontitis

You may not qualify if:

  • Patients with uncontrolled health conditions
  • Immunocompromised patients
  • Teeth with periodontal diseases
  • Teeth with calcified canals
  • pregnant patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, Egypt

RECRUITING

Central Study Contacts

Omnia Hani Mohamed Tawfik

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2024

First Posted

August 27, 2024

Study Start

February 1, 2024

Primary Completion

October 1, 2024

Study Completion

November 1, 2024

Last Updated

August 27, 2024

Record last verified: 2024-08

Locations