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Non-surgical RetreatmentNiTi-RETREATNCT07783945

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

A study testing ProTaper Universal Retreatment System, MicroMega REMOVER and ProTaper Next in people with Non-surgical Retreatment, run by Aydin Adnan Menderes University 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 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Non-surgical Retreatment
What is being tested?
ProTaper Universal Retreatment System, MicroMega REMOVER and ProTaper Next
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
109 participants
Where
1 siteTurkey (Türkiye)
Study dates
10 Mar 2023to 17 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 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.)
Show all 11Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Aydın Adnan Menderes University, Faculty of Dentistiry

    Aydin, Ege, 09000

Other trials in Turkey (Türkiye)

About this study

Official title: Evaluation of the Effect of Different Ni-Ti Shaping Systems on Postoperative Pain and Operation Time in Single-Visit Non-Surgical Retreatment: A Randomized Clinical Trial

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.

Read the detailed description

Postoperative pain is a common complication following nonsurgical endodontic retreatment and may be influenced by the instrumentation system used during root canal filling removal and final root canal shaping. This prospective, single-center, single-blind, randomized clinical trial was designed to compare the effects of different nickel-titanium instrumentation protocols on postoperative pain and operation time in mandibular first molar teeth requiring nonsurgical endodontic retreatment.

Adult participants aged 18-65 years with previously endodontically treated mandibular first molars meeting the eligibility criteria were included. All retreatment procedures were performed in a single visit by one endodontist. Participants were randomly allocated to one of four parallel treatment groups. Existing root canal filling materials were removed using either the ProTaper Universal Retreatment system or the MicroMega REMOVER system. Final root canal shaping was then performed using either the ProTaper Next rotary system or the MicroMega One RECI reciprocating system. Thus, the four intervention groups consisted of ProTaper Universal Retreatment plus ProTaper Next, ProTaper Universal Retreatment plus MicroMega One RECI, MicroMega REMOVER plus ProTaper Next, and MicroMega REMOVER plus MicroMega One RECI.

Postoperative pain intensity was assessed using a 100-mm visual analog scale, in which 0 represented no pain and 100 represented unbearable pain. Participants recorded their pain levels at 6 and 12 hours and on postoperative days 1, 2, 3, 4, 5, 6, and 7. The use and frequency of rescue analgesic medication were also recorded during the seven-day follow-up period. Clinical evaluations were performed at 48 hours and seven days to assess pain, tenderness to percussion, spontaneous pain, swelling, and the need for antibiotic treatment.

Operation time was recorded using a digital stopwatch. The recorded period included the time from the initial penetration into the existing root canal filling material until working length was reached and final root canal shaping was completed. Postoperative pain scores, analgesic consumption, and operation time were compared among the four instrumentation groups.

Being tested
ProTaper Universal Retreatment System, MicroMega REMOVER, ProTaper Next, One RECI
Keywords
Non-surgical retreatment, Operation time, Postoperative pain, Visual analog scale
Medical subject headings
Pain, Postoperative

What participants receive

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

  • ProTaper Universal Retreatment SystemDevice

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

  • MicroMega REMOVERDevice

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

  • ProTaper NextDevice

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

  • One RECIDevice

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

Study groups in NCT07783945
Study groupRoleWhat they receive
PTUR + ProTaper NextExperimentalRoot canal filling materials were removed using the ProTaper Universal Retreatment system. Final root canal shaping was performed using the ProTaper Next rotary instrumentation system.
Receives: Device: ProTaper Universal Retreatment System; Device: ProTaper Next
PTUR + One RECIExperimentalRoot canal filling materials were removed using the ProTaper Universal Retreatment system. Final root canal shaping was performed using the One RECI reciprocating instrumentation system.
Receives: Device: ProTaper Universal Retreatment System; Device: One RECI
REMOVER + ProTaper NextExperimentalRoot canal filling materials were removed using the MicroMega REMOVER system. Final root canal shaping was performed using the ProTaper Next rotary instrumentation system.
Receives: Device: MicroMega REMOVER; Device: ProTaper Next
REMOVER + One RECIExperimentalRoot canal filling materials were removed using the MicroMega REMOVER system. Final root canal shaping was performed using the One RECI reciprocating instrumentation system.
Receives: Device: MicroMega REMOVER; Device: One RECI

What is being measured

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

  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.

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

Secondary outcomes (1)
  1. Operation Time

    The total time required to remove the existing root canal filling material and complete final root canal shaping was recorded in minutes for each participant and compared among the four instrumentation groups.

    Measured: During the single-visit nonsurgical endodontic retreatment procedure.

Timeline

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

  1. First posted25 Aug 2026
  2. Study start10 Mar 2023
  3. Primary completion17 Mar 2024
  4. Study completion17 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
109 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07783945
Sponsor's protocol ID
ADUDHF2023/05
Acronym
NiTi-RETREAT
Status last verified
Aug 2026
First submitted
19 Aug 2026
Last updated
25 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared because participant consent did not include provisions for sharing individual-level data with external researchers.

Publications

  • 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.

    PubMed 32196696
  • 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.

    PubMed 26843876
  • 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.

    PubMed 33609019
  • 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.

    PubMed 34383324
  • 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.

    PubMed 31286116
  • 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.

    PubMed 28477995

Questions about this trial

What is this clinical trial studying?

A study testing ProTaper Universal Retreatment System, MicroMega REMOVER and ProTaper Next in people with Non-surgical Retreatment, run by Aydin Adnan Menderes University 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 8 inclusion and 11 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 25 Aug 2026. 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?

Postoperative Pain Intensity (time frame: At 6, 12, 24, and 48 hours and on postoperative days 3, 4, 5, 6, and 7 after treatment.). 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 NCT07783945, which also lists 6 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 25 Aug 2026.

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