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NCT Number: NCT06545773

Postoperative Pain After Conservative Root Canal Preparation

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

The researcher will perform root canal treatment on lower molar teeth. The researcher will ask about the pain level, painkiller pill number, and swelling on the 6th,12th, 24th, 48th, 72nd hours, and 7th day after the treatment.

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Key information

Conditions

Periapical Diseases Dental Pulp Diseases Dental Pulp Necrosis Disease Attributes Flare Up, Symptom Jaw Diseases Mouth Diseases Necrosis Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Periapical Periodontitis Periodontal Diseases Periodontitis Postoperative Complications Postoperative Pain Pulp Necroses Recurrence Signs and Symptoms Stomatognathic Diseases Symptom Flare Up Tooth Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University Faculty of Dentistry

Istanbul, Fatih, Turkey (Türkiye)

About this study

Root canal shaping is an essential step for root canal treatment. Necrotic tissues, debris, microorganisms, and organic matter should be removed to clean and disinfect the root canals. Previously, this conventional procedure involved removing excessive dentine from root canals, which weakened the tooth's structural integrity. Due to technological advances, excessive dentine removal is not always necessary. Root canals are claimed to be disinfected despite minimal dentine removal. This concept of treatment is called minimally invasive or conservative root canal treatment.

This study compares postoperative pain after conservative and conventional root canal preparation in healthy participants with necrotic mandibular molars.

Participants will be enrolled after clinical and radiographic examination by an independent endodontist and allocated randomly to conventional or conservative root canal treatment groups. After the root canal treatment, the researcher will send the participants an online questionnaire on the 6th,12th, 24th, 48th, and 72nd hours and 7th day and ask them to rate their pain score according to the Numerical Rating System and the number of painkillers they have taken. The flare-up rate will be determined according to the presence of swelling and severe pain.

An experienced endodontist not involved in the research will monitor eligible participants and clinical treatment protocol.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. Postoperative pain

    Time frame: 7 days

    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.

Secondary outcomes

  1. Analgesic intake

    Time frame: 7 days

    Number of painkiller pills will be asked at 6th, 12th, 24th, 48th and 72nd hours and 7th day.

  2. Flare-up

    Time frame: 7 days.

    Presence of Flare-ups will be determined according to swelling and severe pain.

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

Effect of Conservative Root Canal Preparation on Postoperative Pain: A Randomised Clinical Trial

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 9, 2024
Registry last updated
Oct 18, 2024

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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