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Post Operative PainNCT06668662

Comparison of Post-operative Pain After Use of Endo-activator and Conventional Irrigation During Endodontic Treatment in Symptomatic Periapical Periodontitis

A study testing Endoactivator and Conventional irrigation in people with Post Operative Pain and Endodontic Treatment, run by Jinnah Sindh Medical University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Endoactivator and Conventional irrigation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 sitePakistan
Study dates
1 Sep 2023to 31 Mar 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Sindh Institute of Oral Health Sciences Jinnah Sindh Medical University Karachi

    Karachi, Sindh, 75510

Other trials in Pakistan

About this study

Official title: 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).

Read the detailed description

Adequate cleaning of root canal system, along with complete eradication of infected, necrotic pulp remnants, persistent microorganisms, and complete sealing of root canal space is key to successful root canal treatment. Activated irrigation is a method that is used to agitate and increase efficacy of irrigant flow to irregularities of root canal spaces as lateral canals and isthmus by chemo-mechanical or various other energy forms and it is one of the irrigation methods used in this study. It has been shown that EndoActivatorTM system produces the effectual irrigation in all spaces of root canal including as lateral canals, isthmuses and the chances of extrusion of irrigant is less than that compared by means of conventional irrigation methods.Thirty seconds use of activated irrigation solution appeared to be more effective in disinfecting root canal compared with an standard irrigation regimen. The most relevant preferred method of activating the irrigant is by using a non-cutting oscillating ultrasonic tip.

NaOCl is the widely used irrigation solution during chemo-mechanical instrumentation as it has a broad range of antibacterial effect and a high capacity of organic tissue dissolution. It has the dissolution capacity when used in concentrations as low as 2.5%, resulting in decreased antibiofilm effect and removal of organic part of smear layer. Similarly, use of EDTA during the preparation removes the organic part of smear layer resulting in exposure of dentinal tubule and for better penetration of NaOCl for disinfection.1 The same protocol and irrigation techniques were followed in our study to maximize the benefit of NaOCl and EDTA during endodontic treatment.

Many studies have examined effects of different various irrigation methods in relation with endodontic procedures on post-operative pain that corroborate with results of this current study. In this study, working length was determined by use of apex locator i.e. electronic measurement device for root canal length which was then confirmed by digital radiograph. This protocol was followed to ensure that preparation was confined within root canal space, and prevent chances of over instru¬mentation that is considered to be one of those major leading cause of post-operative pain.

The Endoactivator System results in minimal extrusion of irritants and irrigate simulated lateral canals at 4.5 and 2 mm from desired working length as compare to that with conventional methods resulting in better irrigation and decreased post-operative pain among different variables.The highest values of post-operative pain were recorded after 6 hours of treatment that potentially decreased in the follow-up periods until almost disappeared after the time interval of one week. In studies evaluation regarding duration of post-operative pain after root canal treatment was noted in regard with above mentioned aggrement.

Studies by Gondim et al and Topçuoğlu et al also reported lower values of pain in Endovac group com¬pared to conventional needle irrigation showing sig¬nificantly marked results after 6 hours followed by 48 hours-time interval. The chances of extrusion of debris apically was greater resulting in increased level of pain with conventional needle-syringe irrigation due to positive pressure of conventional irrigation.

Nivedhitha S 4 in their study concluded that postoperative pain in patients when irrigation was done by means of endoactivator significantly reduced from 6 hours (35.7 ±17.2) to 7 days (4.8±7.4). Topçuoğlu, concluded that after 24 hours, pain in the conventional irrigation group was higher 3.96± 1.95 while endo activator caused mild pain 2.36±1.32.9 Gündoğar in his study concluded that postoperative pain at 48 hours in conventional irrigation group was 0.23±0.63 while that in the endoactivator group was 0.07±0.37.2 Similarly, in the present study canals irrigated by means of endoactivator reported less post-operative pain as compared to canals irrigated with conventional irrigation.

In the present study, the pain score at 6 hours was 4.82±2.690, while at 24 hours was 3.13±2.62 and reduced significantly at 7 days to 1.55±1.789.

The study is aimed to evaluate comparison related to post-operative pain after use of Endoactivator and conventional irrigation during endodontic treatment in symptomatic periapical periodontitis. The VAS scale is a common acceptable method for measuring postoperative pain in research related to dentistry. This scale was described in detail to the patient before recording their pain intensity on the VAS scale so as to reduce significant chances of errors that patients could make while describing their pain intensity. Therefore, patients were made familiar to the VAS and were assisted accordingly in recording their preoperative and postoperative pain conditions. 20 A recent systematic review by Romualdo et al21 stated that apical extrusion of irrigant was considerably less when using apical negative pressure compared in case of using positive pressure techniques. The conclusive findings elaborated that the negative apical pressure decreases the chances of apical extrusion. In the present study, less pain scores were seen in group of endoactivator as compared to those in conventional irrigation group in first 6 hours. These results may be related to fact that chances of extrusion are less in endoactivator group in comparison to the conventional irrigation group. Tang et al 22 in his study also compared the level of post-endodontic pain after single-visit root canal treatment after 24 hours and after one week time interval. However, level of pain was markedly lower in ultrasonic groups compared to the conventional irrigation group at 24 hours and one week after the procedure.

In the first 6 hours after treatment, the greatest post-operative pain scores were seen in both groups, while subsequent observation time points at 24 hours and 7 days showed significant reduction in pain level in both the study groups. Studies that have evaluated postoperative pain after endodontic treatment have reported similar results. 1,4 Pak and White4 in a systematical review concluded that the prevalence of pain diminished from 40% at 24 hours post-endodontic treatment to 11% at the 7th post-operative day.

One of the strengths of this study was random allocation of patients to groups to minimize confounders. Single operator carrying out all the procedures helped to avoid technical errors and standardize the endodontic procedure. Standard protocols for root canal treatment were adhered to in both the study groups for effective root canal treatment to ensure that the post-operative pain could be attributed only to the difference in irrigation protocols.

Despite of certain strengths, the present study focused primarily on vital pulp of single-rooted teeth with fully formed apices, treated in single visit. Therefore, these results may not directly apply to cases involving multi-rooted teeth or immature apices. Moreover, pain is often difficult to measure and can be attributed to multiple variables, so the pinning only one specific cause of pain is quite difficult. In future, studies can be carried out on multirooted teeth with necrotic pulp, treated in multiple visits to evaluate the effect of endoactivator irrigation or other sonic irrigation methods to assess their effect on post endodontic pain incidence.

CONCLUSION:

This study found that intensity and severity of post-operative pain occurring in patients presenting with symptomatic periapical periodontitis was significantly reduced by use of endoactivator when used with 2.5% NaOCl 7 days after single-visit endodontic treatment.

Being tested
Endoactivator, Conventional irrigation
Keywords
Conventional irrigation, Endoactivator, Post- operative pain, symptomatic periapical periodontitis, Visual Analogue Scale
Medical subject headings
Pain, Postoperative, Periapical Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EndoactivatorDevice

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

  • Conventional irrigationDevice

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

Study groups in NCT06668662
Study groupRoleWhat they receive
endoactivatorActive comparatorEndoactivator is an irrigation technique which will help to reduce post-operative pain in patients following endodontic treatment.
Receives: Device: Endoactivator
Conventional irrigationActive comparatorConventional irrigation is an irrigation technique which will help to reduce post-operative pain in patients following endodontic treatment.
Receives: Device: Conventional irrigation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 6 hours, 24 hours, and at 7 days

  2. 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.

    Measured: 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.

  3. 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.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2024
  2. Study start1 Sep 2023
  3. Primary completion31 Mar 2024
  4. Study completion31 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06668662
Sponsor's protocol ID
JSMU/IRB/2023/714
Status last verified
Oct 2024
First submitted
30 Oct 2024
Last updated
31 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • 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.

Questions about this trial

What is this clinical trial studying?

A study testing Endoactivator and Conventional irrigation in people with Post Operative Pain and Endodontic Treatment, run by Jinnah Sindh Medical University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparison of post-operative pain after use of Endo-activator and conventional irrigation during endodontic treatment in symptomatic periapical periodontitis: a randomized control trial. (time frame: 6 hours, 24 hours, and at 7 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06668662, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2024.

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