Clinical trial NCT06545773: Postoperative Pain After Conservative Root Canal Preparation
Official title: Effect of Conservative Root Canal Preparation on Postoperative Pain: A Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative pain
timeFrame: 7 days
Secondary outcomes:
measure: Analgesic intake
timeFrame: 7 days
measure: Flare-up
timeFrame: 7 days.
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University Faculty of Dentistry
state: Fatih
Study officials:
affiliation: Istanbul University
name: Faruk Haznedaroğlu
role: STUDY_DIRECTOR
References: