Postoperative Pain After Conservative Root Canal Preparation

NCT06545773 | Completed

• 1 other identifier: IstanbulU-1
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare the pain experienced by healthy participants after root canal treatment with small versus large root canal sizes. The main questions it aims to answer are:

1. 1.Do small and large root canal sizes cause different pain levels?
2. 2.What is the number of painkiller pills taken by each participant?
3. 3.Does small root canal size cause severe pain and facial swelling?

Conditions

Periapical Diseases; Periapical Periodontitis; Postoperative Pain; Pulp Necroses; Flare Up, Symptom

Keywords

pain; Nickel Titanium (NiTi); conservative root canal treatment; minimally invasive; flare-up; analgesic

Outcome Measures

Primary Outcomes (1)

• Postoperative pain

  Pain after root canal treatment will be assessed via the Numerical Rating System (NRS) at the 6th, 12th, 24th, 48th, and 72nd hours and on the 7th day. In the NRS, pain is evaluated by numbers from 0 to 10. A score of minimum means no pain, and a score of maximum 10 means the worst pain imaginable.

  7 days

Secondary Outcomes (2)

• Analgesic intake

  7 days

• Flare-up

  7 days.

Study Arms (2)

Group 1: ProTaper Next Nickel-Titanium File (PTN)

EXPERIMENTAL

Root canals will be prepared using the ProTaper Next (PTN) instrument. Coronal flaring will be performed using ProTaper Next XA (accessory) in 300 rpm speed and 2 Ncm torque settings. (The same speed and torque settings will be used for all PTN instruments). The glide path will be prepared with ProGlider (Dentsply, Maillefer). ProTaper Next X1 (17 .04) and then X2 (25 .06) will be advanced in the apical direction using a brushing motion. If debris is observed in the apical part of X2 removed from the root canal after reaching the working length, the shaping of the root canal will be completed, and X3 (30 .07) will not be used. If no debris is observed in the apical part of X2 and the #25 K-File reaches the working length loosely, shaping will be continued with X3. Shaping with ProTaper Next X3 will be done in the same way as X1 and X2.

Procedure: Root Canal Treatment with ProTaper Next Nickel-Titanium File (PTN)

Group 2: TruNatomy Nickel-Titanium File (TN)

EXPERIMENTAL

Root canals will be prepared using the TruNatomy (TN) instrument. Coronal flaring will be performed using the Orifice Modifier (20 .08) at a speed of 400 rpm and a torque setting of 1.5 Ncm. (The same speed and torque settings will be used for all TN instruments.) The Orifice Modifier will be advanced up to 3 mm within the root canal. The guide path will be prepared with TruNatomy Glider (17 .02-variable taper). The TruNatomy Prime (26 .04) file will be used in the canal by moving it apically back and forth 2-3 times and not exceeding 2-5 mm, using a brushing motion. Before proceeding to the TruNatomy Medium (35 .04) file, the debris accumulated in the apical part of the Prime file will be checked. If there is no debris between the apical flutes of the TruNatomy Prime file, shaping will be continued with the TruNatomy Medium file. Shaping with TruNatomy Medium will be done in the same manner as with TN Prime.

Procedure: Root Canal Treatment withTruNatomy Nickel-Titanium File (TN)

Interventions

Root Canal Treatment with ProTaper Next Nickel-Titanium File (PTN) PROCEDURE

ProTaper Next (Dentsply Sirona) is a rotational system made of a nickel-titanium alloy called M-Wire. It has a rectangular cross-sectional design; thus, only two sides touch the root canal. Five files are available: X1 17/. 04, X2 25/.06, X3 30/. 07, X4 40/.06, and X5 50/.06. This file aggressively removes the coronal dentine of root canals due to its large taper. PTN nickel-titanium systemis used in root canal treatments to debride and shape the root canals.

Group 1: ProTaper Next Nickel-Titanium File (PTN)

Root Canal Treatment withTruNatomy Nickel-Titanium File (TN) PROCEDURE

TruNatomy (Dentsply Sirona) is a heat-treated nickel-titanium system that consists of an orifice modifier, glide path, and shaping files. The TruNatomy Small, Prime, and Medium files have sizes of 20/.04, 26/.04, and 35/.04, respectively. It has a rectangular cross-section and a regressive taper. Its slim design allows for a conservative preparation of root canals and the preservation of the coronal dentine. TN nickel-titanium system is used in root canal treatments to debride and shape the root canals.

Group 2: TruNatomy Nickel-Titanium File (TN)

Eligibility Criteria

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

You may qualify if:

• mandibular molar tooth
• asymptomatic apical periodontitis
• pulp necrosis
• periapical lesion index 4 (visible and well-defined periapical lesion)
• absence of pretreatment pain

You may not qualify if:

• symptomatic apical periodontitis
• preoperative pain
• sinus tract
• pulpitis
• acute apical abscess
• tooth not being in occlusion
• external and internal root resorption
• open apices
• periodontal probing depth of more than 4 mm
• initial apical file larger than 15 and 20 K-File for mesial and distal canals respectively
• chronic illness, analgesic allergy, prior analgesic and antibiotics usage 12 hours and 3 months before treatment, respectively

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University Faculty of Dentistry

Istanbul, Fatih, Turkey (Türkiye)

Location

Related Publications (1)

• Vardar Korkman C, Haznedaroglu F. Comparison of postoperative pain after instrumentation with TruNatomy or ProTaper Next Ni-Ti systems in mandibular molars with asymptomatic apical periodontitis: a randomized clinical trial. BMC Oral Health. 2025 Apr 13;25(1):564. doi: 10.1186/s12903-025-05895-6.

  PMID: 40223067 DERIVED

MeSH Terms

Conditions

Periapical Diseases; Periapical Periodontitis; Pain, Postoperative; Dental Pulp Necrosis; Symptom Flare Up; Pain

Condition Hierarchy (Ancestors)

Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Dental Pulp Diseases; Tooth Diseases; Necrosis; Recurrence; Disease Attributes

Study Officials

• Faruk Haznedaroğlu

  Istanbul University

  STUDY DIRECTOR

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: Principal Investigator

Study Record Dates

• First Submitted: August 1, 2024
• First Posted: August 9, 2024
• Study Start: March 4, 2024
• Primary Completion: September 18, 2024
• Study Completion: September 25, 2024
• Last Updated: October 18, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)