Periapical PeriodontitisNCT06339905

The Effects of EndoActivator on Postoperative Pain and Root Canal Treatment Success

A study testing Sonic Activation with EndoActivator in people with Periapical Periodontitis and Root Canal Infection, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).

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

This study evaluates postoperative pain and radiographic healing of asymptomatic posterior teeth with chronic apical periodontitis following root-canal treatment performed using EndoActivator for irrigation activation. Read more about this study

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Periapical Periodontitis, Root Canal Infection
What is being tested?: Sonic Activation with EndoActivator
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 140 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 1 Jan 2022to 31 Aug 2023
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 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

18-60 patient's age
Being systemically healthy
Having posterior teeth (molar or premolar) with chronic apical periodontitis lesion (PAI≥3)

Who cannot join

Clinically symptomatic teeth
Patients with complicated systemic disease (ASA 3 - 6)
Teeth with open apex
Teeth having curvature more than 20 degree
Not having enough tooth structure to be isolated with rubber dam
Patients with severe periodontal defects or deep periodontal pockets (probing depth> 4 mm)
A history of taking analgesics 12 hours ago or antibiotics 1 month ago
Patients who cannot come to control sessions

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Istanbul Medipol University, Faculty of Dentistry
Istanbul, Esenler

Other trials in Turkey (Türkiye)

About this study

Official title: Evaluation of the Effects of EndoActivator Use on Postoperative Pain and Root Canal Treatment Success

Read the detailed description

Aim: To evaluate postoperative pain and radiographic healing of asymptomatic posterior teeth with chronic apical periodontitis following root-canal treatment performed using EndoActivator for irrigation activation.

Methodology: In this clinical trial, root-canal treatment was performed on 140 posterior teeth with chronic apical periodontitis. After routine canal preparation, patients were assigned to either a control group treated using conventional needle irrigation (CNI) without activation or to sonic irrigation activation with EndoActivator. All treatment was completed in a single visit. Patients provided self-assessments of the severity of postoperative pain at 1, 2,3 and 7 days using a Verbal Rating Scale (VRS) and Wong Baker Face Scale. Patients were recalled at 12 months for clinical and radiographic examinations. Periapical healing was evaluated using a periapical index (PAI), with scores of 1 or 2 considered to represent treatment success and scores of 3, 4, or 5 to represent treatment failure. Data were analyzed using one-way ANOVA and Kruskal-Wallis tests, with differences of P < 0.05 considered statistically significant.

Conditions: Periapical Periodontitis, Root Canal Infection
Being tested: Sonic Activation with EndoActivator, Control Needle Irrigation
Keywords: Chronic apical periodontitis, irrigation activation, periapical index, postoperative pain, treatment outcome, periapical health
Medical subject headings: Periapical Periodontitis, Pain, Postoperative

What participants receive

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

Sonic Activation with EndoActivatorProcedure or surgery
Also called EndoActivator (Dentsply Tulsa Dental Specialties, Tulsa, OK, USA)
sonic activation
Control Needle IrrigationProcedure or surgery
Also called CNI
control group

Study groups in NCT06339905
Study group	Role	What they receive
Sonic Activation with EndoActivator	Experimental	Sonic irrigation was performed using an EndoActivator sonic handpiece (Dentsply Tulsa Dental Specialties, Tulsa, OK, USA). A suitable-size activator tip was selected and loosely placed at 2 mm from working length, and the device was operated at 10,000 cycles/min using a pumping action to move the tip to produce vertical strokes of 2-3 mm. Receives: Procedure: Sonic Activation with EndoActivator
Conventional needle irrigation (control)	Active comparator	Conventional needle irrigation was performed with short, in-and-out vertical strokes of 2-3 mm at a rate of approximately 100 strokes per minute. Receives: Procedure: Control Needle Irrigation

What is being measured

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

change from baseline postoperative pain at 1 week
Pain was measured using a Verbal Rating Scale with 4 levels, as follows: 0, no pain; 1, slight pain (mild discomfort, no treatment needed); 2, moderate pain (pain required analgesics for relief); 3, severe pain (pain and/or swelling not relieved by simple analgesics and required unscheduled visit) and Wong Baker Face Scale with six different facial expression. Patients were provided forms and asked to record preoperative pain as well as pain at 1,2,3 and 7 days postoperatively, and to note down the number of analgesics taken. Patients returned their completed forms at their 1-week follow-up visits.
Measured: 1,2,3 and 7 days
change from baseline periapical index at 1 year
Periapical tissue was evaluated using a 5-point periapical index (PAI) (Ørstavik et al. 1986) and scored as follows: 1: Normal periapical structures; 2: Small changes in bone structures; 3: Changes in bone structure with some mineral loss; 4: Periodontitis with well-defined radiolucent area; 5: Severe periodontitis with exacerbating features.
Treatment was considered successful if the patient had no discomfort, no percussion/palpation pain, no sinus tract, no mobility or associated soft-tissue swelling, and a PAI score of ≤ 2. Treatment was considered a failure if the patient could not perform normal masticatory functions, experienced discomfort and percussive pain upon examination, and/or had a PAI score of ≥ 3 .
Measured: Clinical and radiographic examinations were performed on the 1 day of treatment, and 1 year after treatment.]

Timeline

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

1 Jan 202231 Aug 2023

First posted1 Apr 2024
Study start1 Jan 2022
Primary completion31 Aug 2022
Study completion31 Aug 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Periapical PeriodontitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Factorial
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 140 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06339905
Sponsor's protocol ID: 10840098-772.02-5564
Status last verified: May 2024
First submitted: 25 Mar 2024
Last updated: 6 May 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: After its publication in a journal, the investigators want to share their data.

Publications

Orstavik D. Time-course and risk analyses of the development and healing of chronic apical periodontitis in man. Int Endod J. 1996 May;29(3):150-5. doi: 10.1111/j.1365-2591.1996.tb01361.x.
PubMed 9206419
Ramamoorthi S, Nivedhitha MS, Divyanand MJ. Comparative evaluation of postoperative pain after using endodontic needle and EndoActivator during root canal irrigation: A randomised controlled trial. Aust Endod J. 2015 Aug;41(2):78-87. doi: 10.1111/aej.12076. Epub 2014 Sep 4.
PubMed 25195661
Swimberghe RCD, Buyse R, Meire MA, De Moor RJG. Efficacy of different irrigation technique in simulated curved root canals. Lasers Med Sci. 2021 Aug;36(6):1317-1322. doi: 10.1007/s10103-021-03263-8. Epub 2021 Feb 23.
PubMed 33624186
Brito PR, Souza LC, Machado de Oliveira JC, Alves FR, De-Deus G, Lopes HP, Siqueira JF Jr. Comparison of the effectiveness of three irrigation techniques in reducing intracanal Enterococcus faecalis populations: an in vitro study. J Endod. 2009 Oct;35(10):1422-7. doi: 10.1016/j.joen.2009.07.001.
PubMed 19801244

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
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Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)
Not yet recruiting
PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth
Pulp Necrosis, Apical Periodontitis
Not yet recruiting
Influence of Continuous Rotation Versus Reciprocation Motion of MG3 Blue Rotary File on Postoperative Pain and Intracanal Bacterial Reduction of Teeth With Necrotic Pulps.
Necrotic Pulps With no Apical Periodontitis

All Periapical Periodontitis trials

Study at a glance

From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Effects of EndoActivator Use on Postoperative Pain and Root Canal Treatment Success
ClinicalTrials.gov ID: NCT06339905
Acronym / sponsor ID: 10840098-772.02-5564
Conditions: Periapical Periodontitis, Root Canal Infection
Keywords: Chronic apical periodontitis, irrigation activation, periapical index, postoperative pain, treatment outcome, periapical health
Study type: Interventional
Recruitment status: Completed
Enrolment: 140 participants (actual)
Lead sponsor: Istanbul Medipol University HospitalUniversity, hospital or other
Study start: 1 Jan 2022 (actual)
Primary completion: 31 Aug 2022 (actual)
Study completion: 31 Aug 2023 (actual)
First posted: 1 Apr 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Sonic Activation with EndoActivator	Experimental	Procedure: Sonic Activation with EndoActivatorSonic irrigation was performed using an EndoActivator sonic handpiece (Dentsply Tulsa Dental Specialties, Tulsa, OK, USA). A suitable-size activator tip was selected and loosely placed at 2 mm from working length, and the device was operated at 10,000 cycles/min using a pumping action to move the tip to produce vertical strokes of 2-3 mm.
Conventional needle irrigation (control)	Active comparator	Procedure: Control Needle IrrigationConventional needle irrigation was performed with short, in-and-out vertical strokes of 2-3 mm at a rate of approximately 100 strokes per minute.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

18-60 patient's age
Being systemically healthy
Having posterior teeth (molar or premolar) with chronic apical periodontitis lesion (PAI≥3)

Key exclusion criteria (8 listed)

Clinically symptomatic teeth
Patients with complicated systemic disease (ASA 3 - 6)
Teeth with open apex
Teeth having curvature more than 20 degree
Not having enough tooth structure to be isolated with rubber dam

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Sonic Activation with EndoActivatorAlso: EndoActivator (Dentsply Tulsa Dental Specialties, Tulsa, OK, USA)sonic activation	Procedure or surgery	Sonic Activation with EndoActivator
Control Needle IrrigationAlso: CNIcontrol group	Procedure or surgery	Conventional needle irrigation (control)

Primary outcome

change from baseline postoperative pain at 1 week
Time frame: 1,2,3 and 7 days
Pain was measured using a Verbal Rating Scale with 4 levels, as follows: 0, no pain; 1, slight pain (mild discomfort, no treatment needed); 2, moderate pain (pain required analgesics for relief); 3, severe pain (pain and/or swelling not relieved by simple analgesics and required unscheduled visit) and Wong Baker Face Scale with six different facial expression. Patients were provided forms and asked to record preoperative pain as well as pain at 1,2,3 and 7 days postoperatively, and to note down the number of analgesics taken. Patients returned their completed forms at their 1-week follow-up visits.
change from baseline periapical index at 1 year
Time frame: Clinical and radiographic examinations were performed on the 1 day of treatment, and 1 year after treatment.]
Periapical tissue was evaluated using a 5-point periapical index (PAI) (Ørstavik et al. 1986) and scored as follows: 1: Normal periapical structures; 2: Small changes in bone structures; 3: Changes in bone structure with some mineral loss; 4: Periodontitis with well-defined radiolucent area; 5: Severe periodontitis with exacerbating features. Treatment was considered successful if the patient had no discomfort, no percussion/palpation pain, no sinus tract, no mobility or associated soft-tissue swelling, and a PAI score of ≤ 2. Treatment was considered a failure if the patient could not perform normal masticatory functions, experienced discomfort and percussive pain upon examination, and/or had a PAI score of ≥ 3 .

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
Background: PubMed 9206419Orstavik D. Time-course and risk analyses of the development and healing of chronic apical periodontitis in man. Int Endod J. 1996 May;29(3):150-5. doi: 10.1111/j.1365-2591.1996.tb01361.x.
Background: PubMed 25195661Ramamoorthi S, Nivedhitha MS, Divyanand MJ. Comparative evaluation of postoperative pain after using endodontic needle and EndoActivator during root canal irrigation: A randomised controlled trial. Aust Endod J. 2015 Aug;41(2):78-87. doi: 10.1111/aej.12076. Epub 2014 Sep 4.
Background: PubMed 33624186Swimberghe RCD, Buyse R, Meire MA, De Moor RJG. Efficacy of different irrigation technique in simulated curved root canals. Lasers Med Sci. 2021 Aug;36(6):1317-1322. doi: 10.1007/s10103-021-03263-8. Epub 2021 Feb 23.
Background: PubMed 19801244Brito PR, Souza LC, Machado de Oliveira JC, Alves FR, De-Deus G, Lopes HP, Siqueira JF Jr. Comparison of the effectiveness of three irrigation techniques in reducing intracanal Enterococcus faecalis populations: an in vitro study. J Endod. 2009 Oct;35(10):1422-7. doi: 10.1016/j.joen.2009.07.001.
Individual participant dataSharing planned: Yes. After its publication in a journal, the investigators want to share their data.

Related trials for Periapical Periodontitis

Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
Recruiting
Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)
Not yet recruiting
PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth
Pulp Necrosis, Apical Periodontitis
Not yet recruiting
Influence of Continuous Rotation Versus Reciprocation Motion of MG3 Blue Rotary File on Postoperative Pain and Intracanal Bacterial Reduction of Teeth With Necrotic Pulps.
Necrotic Pulps With no Apical Periodontitis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Seyda Ersahan, PhD principal investigator

Istanbul Medipol University Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Sonic Activation with EndoActivator in people with Periapical Periodontitis and Root Canal Infection, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).

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 3 inclusion and 8 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 6 May 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 Turkey (Türkiye). 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?

change from baseline postoperative pain at 1 week (time frame: 1,2,3 and 7 days). The study lists 2 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 NCT06339905, which also lists 4 linked publications.

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 6 May 2024.