Clinical trial NCT05927025: Can the Different Instruments Used ın Root Canal Treatment Have an Effect on Postoperative Pain?
Official title: Evaluation of Different NiTi Rotary Files With NiTi Hand Files to Postoperative Pain Effects : A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Keywords: Root canal treatment
Nickel-Titanium instruments
Postoperative pain
Primary tooth
Lead sponsor: Necmettin Erbakan University
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 100
Sex: ALL
Minimum age (years): 5
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Postoperative Pain Assessments
timeFrame: 6 hours
measure: Postoperative Pain Assessments
timeFrame: 12 hours
measure: Postoperative Pain Assessments
timeFrame: 24 hours
measure: Postoperative Pain Assessments
timeFrame: 48 hours
measure: Postoperative Pain Assessments
timeFrame: 72 hours
measure: Postoperative Pain Assessments
timeFrame: 1 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Necmettin Erbakan University
Study officials:
References: