Flare Up, Symptom, Periapical Diseases, Periapical Periodontitis, Postoperative Pain, Pulp Necroses
Conditions
Keywords
pain, Nickel Titanium (NiTi), conservative root canal treatment, minimally invasive, flare-up, analgesic
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.
Interventions
PROCEDURERoot Canal Treatment with ProTaper Next Nickel-Titanium File (PTN)
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.
PROCEDURERoot Canal Treatment withTruNatomy Nickel-Titanium File (TN)
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.
Sponsors
Istanbul University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain | 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
| Measure | Time frame | Description |
|---|---|---|
| Analgesic intake | 7 days | Number of painkiller pills will be asked at 6th, 12th, 24th, 48th and 72nd hours and 7th day. |
| Flare-up | 7 days. | Presence of Flare-ups will be determined according to swelling and severe pain. |
Countries
Turkey (Türkiye)
Outcome results
None listed