NCT06668662

Brief Summary

Introduction: The adequate removal of microorganisms, infected or necrotic pulp tissues and complete adequate seal of root canal system along with debridement is key to success of endodontic treatment. The objective of this study was to compare frequency of pain after using Endo Activator and conventional irrigation in patients presenting with symptomatic periapical periodontitis following endodontic treatment by means of Visual Analog Scale. Methods: This study was designed as single blind, randomized control trial. Sixty patients with symptomatic teeth requiring endodontic canal treatment were recruited by probability random sampling into two groups based on irrigation protocols used during endodontic treatment: conventional needle and endo activator irrigation system. The post-operative pain of patients was recorded via a telephone call at 6 hours, 24 hours, and at 7 days on the visual analogue scale (VAS).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

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

September 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 30, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 31, 2024

Completed
Last Updated

October 31, 2024

Status Verified

October 1, 2024

Enrollment Period

7 months

First QC Date

October 30, 2024

Last Update Submit

October 30, 2024

Conditions

Keywords

Conventional irrigationEndoactivatorPost- operative painsymptomatic periapical periodontitisVisual Analogue Scale

Outcome Measures

Primary Outcomes (3)

  • Comparison of post-operative pain after use of Endo-activator and conventional irrigation during endodontic treatment in symptomatic periapical periodontitis: a randomized control trial.

    Introduction: The adequate removal of microorganisms, infected or necrotic pulp tissues and complete adequate seal of root canal system along with debridement is key to success of endodontic treatment. The objective of this study was to compare frequency of pain after using Endo Activator and conventional irrigation in patients presenting with symptomatic periapical periodontitis following endodontic treatment by means of Visual Analog Scale. Methods: This study was designed as single blind, randomized control trial .Sixty patients with symptomatic teeth requiring endodontic canal treatment were recruited by probability random sampling into two groups based on irrigation protocols used during endodontic treatment: conventional needle and endo activator irrigation system. The post-operative pain of patients was recorded via a telephone call at 6 hours, 24 hours, and at 7 days on the visual analogue scale (VAS).

    6 hours, 24 hours, and at 7 days

  • Endoactivator

    conventional endodontic needle 4 mL of 2.5% NaOCl was delivered into pulp chamber and then an Endoactivator tip (size #15.02) (DENTSPLY/ Tulsa Dental Specialties, OK) was placed loosely 2 mm short of working length, and activated at 20000 Hz in each canal, moving in a constant in and out motion. The NaOCl was agitated for one minute with approximately 2-3 mm vertical strokes.

    The patients were contacted via telephone after 6 hours, 24 hours and 7 days to ask and record their postoperative pain on visual analogue scale that consist of 10cm line anchored by 1 denoting mild and 10 being most severe.

  • Conventional irrigation

    by placing the needle 2 mm short of desired working length, 4 mL of 2.5% NaOCl was placed into each canal for 40 secs with an approximate flow rate of 0.1 mL/s.

    The patients were contacted via telephone after 6 hours, 24 hours and 7 days to ask and record their postoperative pain on visual analogue scale that consist of 10cm line anchored by 1 denoting mild and 10 being most severe.

Study Arms (2)

endoactivator

ACTIVE COMPARATOR

Endoactivator is an irrigation technique which will help to reduce post-operative pain in patients following endodontic treatment.

Device: Endoactivator

Conventional irrigation

ACTIVE COMPARATOR

Conventional irrigation is an irrigation technique which will help to reduce post-operative pain in patients following endodontic treatment.

Device: Conventional irrigation

Interventions

Endoactivator is an irrigation technique which will help to reduce post-operative pain in patients following endodontic treatment.

endoactivator

Conventional irrigation is an irrigation technique which will help to reduce post-operative pain in patients following endodontic treatment.

Conventional irrigation

Eligibility Criteria

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

You may qualify if:

  • Patients not taking any sedative or analgesics medication 48 hours prior to presenting to the dental clinic
  • The teeth that were included were tender to percussion and palpation but had a sound periodontium and no inflammatory exudate or pus drainage.

You may not qualify if:

  • Patients with any systemic diseases,
  • retreatment cases,
  • or teeth with calcified canals were excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sindh Institute of Oral Health Sciences Jinnah Sindh Medical University Karachi

Karachi, Sindh, 75510, Pakistan

Location

Related Publications (1)

  • 1. Salim A, Darrag A, Ghoneim W. Post-Operative Pain after Single-Visit Endodontic treatment using different root canal irrigation activating techniques. Egypt Dent J. 2021;67(4):3719-30.

    RESULT

MeSH Terms

Conditions

Pain, PostoperativePeriapical Periodontitis

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsPeriapical DiseasesJaw DiseasesStomatognathic DiseasesPeriodontal DiseasesMouth DiseasesPeriodontitis

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

October 30, 2024

First Posted

October 31, 2024

Study Start

September 1, 2023

Primary Completion

March 31, 2024

Study Completion

March 31, 2024

Last Updated

October 31, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will share

Locations