Periapical PeriodontitisNCT03990584

Effects of Irrigation Activation on Clinical Outcomes of Root Canal Treatment

A study testing three irrigation activation methods and conventional needle irrigation 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 different methods of irrigation activation. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Periapical Periodontitis, Root Canal Infection
What is being tested?: three irrigation activation methods and conventional needle irrigation
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 150 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 1 Feb 2018to 1 May 2019
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

a non-contributory medical history
must have an asymptomatic, necrotic premolar or molar with periapical lesions of > 2.0 x 2.0 mm around one or both roots
must be diagnosed as chronic apical periodontitis

Who cannot join

Those with clinical symptoms (acute pain)
have periapical radiolucency of >5 mm
no previous endodontic treatment
no severe periodontal disease in the related tooth
non-restorable tooth
use of any analgesics within the previous 3 days or antibiotics within the previous month

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: Effects of Irrigation Activation on Clinical Outcomes of Root Canal Treatment in Posterior Teeth With Chronic Apical Periodontitis

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 different methods of irrigation activation.

Methodology: In this prospective clinical trial, root-canal treatment was performed on 162 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 one of 3 treatment groups, each of which was treated using a different activation protocol during the final irrigation [manual dynamic irrigation (MDI), passive ultrasonic irrigation (PUI), sonic irrigation (SI)]. All treatment was completed in a single visit. Patients provided self-assessments of the severity of postoperative pain at 24h, 48h and 7 days using a modified 4-step visual analogue scale (VAS). Patients were recalled at 12 months for clinical and radiographic examinations. Periodontal 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: three irrigation activation methods, conventional needle irrigation
Keywords: Chronic apical periodontitis, irrigation activation methods, periapical index, postoperative pain, treatment outcome
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.

three irrigation activation methodsProcedure or surgery
Also called passive ultrasonic irrigation (Irrisafe; Satelec Acteon, Mérignac, France), sonic irrigation (Dentsply Tulsa Dental Specialties, Tulsa, OK, USA), manual dynamic irrigation (Kerr Dental, USA)
passive ultrasonic irrigation, sonic irrigation, manual dynamic irrigation
conventional needle irrigationProcedure or surgery
conventional needle irrigation

Study groups in NCT03990584
Study group	Role	What they receive
three irrigation activation methods	Experimental	Manual dynamic irrigation was performed using a well-fitting gutta-percha cone inserted to WL with in-and-out vertical strokes of 5 mm at a rate of approximately 100 strokes per minute in order to hydrodynamically displace the irrigant. Passive ultrasonic irrigation was performed using a non-cutting size 25 file attached to a piezoelectric ultrasonic unit. 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: three irrigation activation methods
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: conventional 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 modified visual analogue scale (VAS) with 4 levels, as follows: 1, no pain; 2, slight pain (mild discomfort, no treatment needed); 3, moderate pain (pain required analgesics for relief); 4, severe pain (pain and/or swelling not relieved by simple analgesics and required unscheduled visit). Patients were provided forms and asked to record preoperative pain as well as pain at 24 hours, 48 hours and 1 week postoperatively, and to note down the number of analgesics taken. Patients returned their completed forms at their 1-week follow-up visits.
Measured: 24 hours, 48 hours and 1 week postoperatively
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. If scores varied among roots in the same tooth, the highest score was recorded for that tooth. Similarly, if scores varied between observers for the same tooth, the higher score was recorded.
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,1 day after 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 Feb 20181 May 2019

First posted19 Jun 2019
Study start1 Feb 2018
Primary completion1 May 2018
Study completion1 May 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)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: 150 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03990584
Sponsor's protocol ID: 10840098-604.01.01-E34148
Status last verified: Jun 2019
First submitted: 14 Jun 2019
Last updated: 19 Jun 2019
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, we want to share our data

Publications

Andrabi SM, Kumar A, Zia A, Iftekhar H, Alam S, Siddiqui S. Effect of passive ultrasonic irrigation and manual dynamic irrigation on smear layer removal from root canals in a closed apex in vitro model. Journal of Investigative and Clinical Dentistry 5: 188-93, 2014. Akerblom A, Hasselgren G. The prognosis for endodontic treatment of obliterated root canals. Journal of Endodontics 14: 565-7, 1998. Attar S, Bowles WR, Baisden MK, Hodges JS, McClanahan SB. Evaluation of pretreatment analgesia and endodontic treatment for postoperative endodontic pain. Journal of Endodontics 34: 652-5, 2008. Brito PR, Souza LC, Machado de Oliveira JC et al. Comparison of the effectiveness of three irrigation techniques in reducing intracanal Enterococcus faecalis populations: an in vitro study. Journal of Endodontics 35: 1422-7, 2009. Brynolf I (1967) A histological and roentgenological study of the periapical region of human upper incisors. Odontologisk Revy 18, 1-176.1-176. Cameron JA (1988) The effect of ultrasonic endodontics on the temperature of the root canal wall. Journal of Endodontics 14, 554-8. Card SJ, Sigurdsson A, Ørstavik D, Trope M . The effectiveness of increased apical enlargement in reducing intracanal bacteria. Journal of Endodontics 28: 779-83, 2002. de Gregorio C, Estevez R, Cisneros R, Heilborn C, Cohenca N . Effect of EDTA, sonic, and ultrasonic activation on the penetration of sodium hypochlorite into simulated lateral canals: an in vitro study. Journal of Endodontics 35: 891-5, 2009. de Gregorio C, Estevez R, Cisneros R, Paranjpe A, Cohenca N . Efficacy of different irrigation and activation systems on the penetration of sodium hypochlorite into simulated lateral canals and up to working length: an in vitro study. Journal of Endodontics 36: 1216-1221, 2010. Desai P, Himel V .Comparative safety of various intracanal irrigation systems. Journal of Endodontics 35: 545-9, 2009.

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

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

All Periapical Periodontitis trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Irrigation Activation on Clinical Outcomes of Root Canal Treatment in Posterior Teeth With Chronic Apical Periodontitis
ClinicalTrials.gov ID: NCT03990584
Acronym / sponsor ID: 10840098-604.01.01-E34148
Conditions: Periapical Periodontitis, Root Canal Infection
Keywords: Chronic apical periodontitis, irrigation activation methods, periapical index, postoperative pain, treatment outcome
Study type: Interventional
Recruitment status: Completed
Enrolment: 150 participants (actual)
Lead sponsor: Istanbul Medipol University HospitalUniversity, hospital or other
Study start: 1 Feb 2018 (actual)
Primary completion: 1 May 2018 (actual)
Study completion: 1 May 2019 (actual)
First posted: 19 Jun 2019 (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
three irrigation activation methods	Experimental	Procedure: three irrigation activation methodsManual dynamic irrigation was performed using a well-fitting gutta-percha cone inserted to WL with in-and-out vertical strokes of 5 mm at a rate of approximately 100 strokes per minute in order to hydrodynamically displace the irrigant. Passive ultrasonic irrigation was performed using a non-cutting size 25 file attached to a piezoelectric ultrasonic unit. 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.
Conventional needle irrigation (control)	Active comparator	Procedure: conventional 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 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

a non-contributory medical history
must have an asymptomatic, necrotic premolar or molar with periapical lesions of > 2.0 x 2.0 mm around one or both roots
must be diagnosed as chronic apical periodontitis

Key exclusion criteria (6 listed)

Those with clinical symptoms (acute pain)
have periapical radiolucency of >5 mm
no previous endodontic treatment
no severe periodontal disease in the related tooth
non-restorable tooth

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
three irrigation activation methodsAlso: passive ultrasonic irrigation (Irrisafe; Satelec Acteon, Mérignac, France), sonic irrigation (Dentsply Tulsa Dental Specialties, Tulsa, OK, USA), manual dynamic irrigation (Kerr Dental, USA)passive ultrasonic irrigation, sonic irrigation, manual dynamic irrigation	Procedure or surgery	three irrigation activation methods
conventional needle irrigationconventional needle irrigation	Procedure or surgery	Conventional needle irrigation (control)

Primary outcome

change from baseline postoperative pain at 1 week
Time frame: 24 hours, 48 hours and 1 week postoperatively
Pain was measured using a modified visual analogue scale (VAS) with 4 levels, as follows: 1, no pain; 2, slight pain (mild discomfort, no treatment needed); 3, moderate pain (pain required analgesics for relief); 4, severe pain (pain and/or swelling not relieved by simple analgesics and required unscheduled visit). Patients were provided forms and asked to record preoperative pain as well as pain at 24 hours, 48 hours and 1 week 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,1 day after 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. If scores varied among roots in the same tooth, the highest score was recorded for that tooth. Similarly, if scores varied between observers for the same tooth, the higher score was recorded. 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 19 Jun 2019.
BackgroundAndrabi SM, Kumar A, Zia A, Iftekhar H, Alam S, Siddiqui S. Effect of passive ultrasonic irrigation and manual dynamic irrigation on smear layer removal from root canals in a closed apex in vitro model. Journal of Investigative and Clinical Dentistry 5: 188-93, 2014. Akerblom A, Hasselgren G. The prognosis for endodontic treatment of obliterated root canals. Journal of Endodontics 14: 565-7, 1998. Attar S, Bowles WR, Baisden MK, Hodges JS, McClanahan SB. Evaluation of pretreatment analgesia and endodontic treatment for postoperative endodontic pain. Journal of Endodontics 34: 652-5, 2008. Brito PR, Souza LC, Machado de Oliveira JC et al. Comparison of the effectiveness of three irrigation techniques in reducing intracanal Enterococcus faecalis populations: an in vitro study. Journal of Endodontics 35: 1422-7, 2009. Brynolf I (1967) A histological and roentgenological study of the periapical region of human upper incisors. Odontologisk Revy 18, 1-176.1-176. Cameron JA (1988) The effect of ultrasonic endodontics on the temperature of the root canal wall. Journal of Endodontics 14, 554-8. Card SJ, Sigurdsson A, Ørstavik D, Trope M . The effectiveness of increased apical enlargement in reducing intracanal bacteria. Journal of Endodontics 28: 779-83, 2002. de Gregorio C, Estevez R, Cisneros R, Heilborn C, Cohenca N . Effect of EDTA, sonic, and ultrasonic activation on the penetration of sodium hypochlorite into simulated lateral canals: an in vitro study. Journal of Endodontics 35: 891-5, 2009. de Gregorio C, Estevez R, Cisneros R, Paranjpe A, Cohenca N . Efficacy of different irrigation and activation systems on the penetration of sodium hypochlorite into simulated lateral canals and up to working length: an in vitro study. Journal of Endodontics 36: 1216-1221, 2010. Desai P, Himel V .Comparative safety of various intracanal irrigation systems. Journal of Endodontics 35: 545-9, 2009.
Individual participant dataSharing planned: Yes. After its publication in a journal, we want to share our 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?

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 6 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 19 Jun 2019. 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: 24 hours, 48 hours and 1 week postoperatively). 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 NCT03990584, 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 19 Jun 2019.