Effects of Different NiTi Systems on Postoperative Pain and Operation Time in Nonsurgical Endodontic Retreatment

NCT07783945 | Completed

• 1 other identifier: ADUDHF2023/05
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, randomized, single-center, single-blind clinical trial evaluated the effects of different nickel-titanium retreatment and final shaping systems on postoperative pain and operation time during single-visit nonsurgical endodontic retreatment of mandibular first molars. Participants were allocated to four groups according to the combination of the retreatment system used for root canal filling removal and the rotary or reciprocating system used for final root canal shaping. Postoperative pain, analgesic consumption, and operation time were assessed and compared among the groups.

Conditions

Non-surgical Retreatment

Keywords

Non-surgical retreatment; Operation time; Postoperative pain; Visual analog scale

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain Intensity

  Postoperative pain intensity was assessed using a 100-mm visual analog scale, where 0 indicated no pain and 100 indicated the worst imaginable pain. Pain scores were compared among the four instrumentation groups.

  At 6, 12, 24, and 48 hours and on postoperative days 3, 4, 5, 6, and 7 after treatment.

Secondary Outcomes (1)

• Operation Time

  During the single-visit nonsurgical endodontic retreatment procedure.

Study Arms (4)

PTUR + ProTaper Next

EXPERIMENTAL

Root canal filling materials were removed using the ProTaper Universal Retreatment system. Final root canal shaping was performed using the ProTaper Next rotary instrumentation system.

Device: ProTaper Universal Retreatment System; Device: ProTaper Next

PTUR + One RECI

EXPERIMENTAL

Root canal filling materials were removed using the ProTaper Universal Retreatment system. Final root canal shaping was performed using the One RECI reciprocating instrumentation system.

Device: ProTaper Universal Retreatment System; Device: One RECI

REMOVER + ProTaper Next

EXPERIMENTAL

Root canal filling materials were removed using the MicroMega REMOVER system. Final root canal shaping was performed using the ProTaper Next rotary instrumentation system.

Device: MicroMega REMOVER; Device: ProTaper Next

REMOVER + One RECI

EXPERIMENTAL

Root canal filling materials were removed using the MicroMega REMOVER system. Final root canal shaping was performed using the One RECI reciprocating instrumentation system.

Device: MicroMega REMOVER; Device: One RECI

Interventions

ProTaper Universal Retreatment System DEVICE

A nickel-titanium rotary retreatment system used for the removal of existing root canal filling materials during nonsurgical endodontic retreatment.

PTUR + One RECI; PTUR + ProTaper Next

MicroMega REMOVER DEVICE

A nickel-titanium rotary retreatment instrument used for the removal of existing root canal filling materials during nonsurgical endodontic retreatment.

REMOVER + One RECI; REMOVER + ProTaper Next

ProTaper Next DEVICE

A nickel-titanium rotary instrumentation system used for final root canal shaping following the removal of existing root canal filling materials.

PTUR + ProTaper Next; REMOVER + ProTaper Next

One RECI DEVICE

A nickel-titanium reciprocating instrumentation system used for final root canal shaping following the removal of existing root canal filling materials.

PTUR + One RECI; REMOVER + One RECI

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients between 18- 65 years of ages
• Patients who agree to participate this study
• Patients had not used analgesic or antibiotics in last 7 days
• Mandibular molar teeth that have been endodontically treated only once
• Asymptomatic teeth with previous endodontic treatment but exhibiting inadequate root canal filling on radiographic examination.
• Teeth, although asymptomatic, but with newly developed periapical radiolucency within two years compared to the radiographic findings present 2 years ago at the time of root canal treatment was done.
• Teeth with periapical radiolucency, but with increased or unchanged according to pre-treatment radiography.
• Absence of a history of allergy to local anesthetics, medications, resin-based restorative materials or nickel.

You may not qualify if:

• Pregnant patients and patients in lactation period
• Having used corticosteroids in the last 6 months.
• Individuals with systemic diseases (endocarditis, immune system diseases, etc.) requiring antibiotic prophylaxis
• Having received immunosuppressive therapy within the last week
• Gingival recession exceeding 3 mm, deep periodontal pocketing, tooth mobility, or progressive periodontal disease
• The presence of a foreign body in the root canal that prevents entry (broken file, post, etc.)
• Fracture or crack in the root
• Teeth that cannot reach the working length due to calcification in the root canal and step formation
• Teeth that cannot be restored due to excessive loss of material in the coronal structure
• The presence of more than one adjacent tooth requiring endodontic treatment that may cause reflected pain in the same patient.
• Teeth that develop any complications (breakage of endodontic file, perforation, inability to determine the working length with the apex finder) during the removal of the canal filling material.

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (1)

Aydın Adnan Menderes University, Faculty of Dentistiry

Aydin, Ege, 09000, Turkey (Türkiye)

Location

Related Publications (6)

• Nagendrababu V, Duncan HF, Bjorndal L, Kvist T, Priya E, Jayaraman J, Pulikkotil SJ, Pigg M, Rechenberg DK, Vaeth M, Dummer PMH. PRIRATE 2020 guidelines for reporting randomized trials in Endodontics: a consensus-based development. Int Endod J. 2020 Jun;53(6):764-773. doi: 10.1111/iej.13294. Epub 2020 Apr 23.

  PMID: 32196696 BACKGROUND

• Shahi S, Asghari V, Rahimi S, Lotfi M, Samiei M, Yavari H, Shakouie S, Nezafati S. Postoperative Pain after Endodontic Treatment of Asymptomatic Teeth Using Rotary Instruments: A Randomized Clinical Trial. Iran Endod J. 2016 Winter;11(1):38-43. doi: 10.7508/iej.2016.01.008. Epub 2015 Dec 24.

  PMID: 26843876 BACKGROUND

• Rahbani Nobar B, Dianat O, Rahbani Nobar B, Shirvani A, Zargar N, Kazem M, Tordik P. Effect of Rotary and Reciprocating Instrumentation Motions on Postoperative Pain Incidence in Non-Surgical Endodontic Treatments: A Systematic Review and Meta-Analysis. Eur Endod J. 2021 Apr;6(1):3-14. doi: 10.14744/eej.2020.51523. Epub 2021 Feb 2.

  PMID: 33609019 BACKGROUND

• Canakci BC, Er O, Genc Sen O, Sut N. The effect of two rotary and two reciprocating NiTi systems on postoperative pain after root canal retreatment on single-rooted incisor teeth: A randomized controlled trial. Int Endod J. 2021 Nov;54(11):2016-2024. doi: 10.1111/iej.13609. Epub 2021 Aug 29.

  PMID: 34383324 BACKGROUND

• Eyuboglu TF, Ozcan M. Postoperative pain intensity associated with the use of different nickel-titanium shaping systems during single-appointment endodontic retreatment: a randomized clinical trial. Quintessence Int. 2019;50(8):624-634. doi: 10.3290/j.qi.a42693.

  PMID: 31286116 BACKGROUND

• Comparin D, Moreira EJL, Souza EM, De-Deus G, Arias A, Silva EJNL. Postoperative Pain after Endodontic Retreatment Using Rotary or Reciprocating Instruments: A Randomized Clinical Trial. J Endod. 2017 Jul;43(7):1084-1088. doi: 10.1016/j.joen.2017.02.010. Epub 2017 May 3.

  PMID: 28477995 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

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: Assoc. Prof.

Study Record Dates

• First Submitted: August 19, 2026
• First Posted: August 25, 2026
• Study Start: March 10, 2023
• Primary Completion: March 17, 2024
• Study Completion: March 17, 2024
• Last Updated: August 25, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)