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Can the Different Instruments Used ın Root Canal Treatment Have an Effect on Postoperative Pain?

Evaluation of Different NiTi Rotary Files With NiTi Hand Files to Postoperative Pain Effects : A Randomized Controlled Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05927025
Enrollment
100
Registered
2023-07-03
Start date
2022-04-01
Completion date
2023-01-18
Last updated
2023-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

Keywords

Root canal treatment, Nickel-Titanium instruments, Postoperative pain, Primary tooth

Brief summary

Root canal treatment is a treatment method in which the pulp is irreversibly infected due to caries or trauma or when the pulp loses its vitality. Biomechanical preparation of primary teeth is an important step for a successful root canal treatment. The success of root canal treatment depends not only on the biological results of the treatment, but also on minimizing the postoperative pain of the patients. Therefore, the elimination of factors associated with postoperative pain has an important role in the prognosis of patients after treatment. In all root canal preparation methods, some debris overflows from the apical. Debris protruding into the apical area causes postoperative pain. Many studies in the literature have shown that NiTi rotary files cause less extrusion of debris compared to hand files, and therefore less postoperative pain. Within the scope of this study, the effect of NiTi K hand file and WaveOne Gold, ProTaper Next, EndoArt NiTi Pedo Gold file, AF Baby rotary file systems on postoperative pain in root canal treatment preparations applied to the mandibular primary molar teeth of pediatric patients aged 5-8 years. It is intended to be evaluated using VAS). In our research; ProTaper Next (PTN), WaveOne Gold (WOG), AF Baby rotary file, EndoArt NiTi Pedo Gold file, NiTi K type hand files were used. 100 patients between the ages of 5 and 8 who had root canal treatment indications for mandibular primary second molars were included in the study. The patients were divided into 5 groups with 20 patients in each group. All systems were used according to the manufacturer's instructions and all treatments were performed by a single operator in a single session. Postoperative pain was recorded using the Visual Analog Scale (VAS) at the 6th, 12th, 18th, 24th, 48th, 72nd hour and 1st week following treatment. The obtained data were evaluated statistically.

Interventions

PROCEDUREHand K-files

It is used for cleaning and shaping root canals.

Sponsors

Necmettin Erbakan University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

Masking was applied only to the patients and their parents included in the study.

Eligibility

Sex/Gender
ALL
Age
5 Years to 8 Years
Healthy volunteers
Yes

Inclusion criteria

* No analgesic use 12 hours before root canal treatment * No systemic disease. * Teeth with a diagnosis of irreversible pulpitis, no other teeth causing pain at the site of the tooth to be treated, no inter-root bone loss exceeding 1/3, and root canal inclinations of no more than 25° according to Schneider method were included in the study.

Exclusion criteria

* Patients with post-procedural analgesic use were excluded from the study * Patients whose parents did not fully understand the instructions and who did not attend the follow-up visit one week after treatment were excluded.

Design outcomes

Primary

MeasureTime frameDescription
Postoperative Pain Assessments6 hoursEvaluation of the effect on pain after root canal treatment; Parents were trained to use the pain scale; Postoperative pain occurring at the 6th hour was evaluated. All parents participating in the study were blinded to the treatment protocol used for the children. Evaluation of postoperative pain was performed using the VAS . It was explained that the closest score between 0 no pain and 10 severe pain scores should be recorded by the parents.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026