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Completed

NCT Number: NCT07783945

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aydın Adnan Menderes University, Faculty of Dentistiry

Aydin, Ege, 09000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

MicroMega REMOVER

Device

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

ProTaper Next

Device

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

One RECI

Device

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

Primary outcomes

  1. Postoperative Pain Intensity

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

    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.

Secondary outcomes

  1. Operation Time

    Time frame: During the single-visit nonsurgical endodontic retreatment procedure.

    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.

Sponsors and collaborators

Lead sponsor

Aydin Adnan Menderes University

Other

Registry information

Official study 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

Acronym: NiTi-RETREAT

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 25, 2026
Registry last updated
Aug 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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