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Completed

NCT Number: NCT05927025

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

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.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

5 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Necmettin Erbakan University

Konya, 42090, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Hand K-files

Procedure

It is used for cleaning and shaping root canals.

Other names: ProTaper Next, WaveOne Gold, AF Baby Rotary File, EndoArt NiTi Pedo Golf File

Primary outcomes

  1. Postoperative Pain Assessments

    Time frame: 6 hours

    Evaluation 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.

  2. Postoperative Pain Assessments

    Time frame: 12 hours

    Evaluation of the effect on pain after root canal treatment; Parents were trained to use the pain scale; Postoperative pain occurring at the 12th 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.

  3. Postoperative Pain Assessments

    Time frame: 24 hours

    Evaluation of the effect on pain after root canal treatment; Parents were trained to use the pain scale; Postoperative pain occurring at the 24th 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.

  4. Postoperative Pain Assessments

    Time frame: 48 hours

    Evaluation of the effect on pain after root canal treatment; Parents were trained to use the pain scale; Postoperative pain occurring at the 48th 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.

  5. Postoperative Pain Assessments

    Time frame: 72 hours

    Evaluation of the effect on pain after root canal treatment; Parents were trained to use the pain scale; Postoperative pain occurring at the 72nd 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.

  6. Postoperative Pain Assessments

    Time frame: 1 weeks

    Evaluation of the effect on pain after root canal treatment; Parents were trained to use the pain scale; Postoperative pain occurring at the 1st week 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.

Sponsors and collaborators

Lead sponsor

Necmettin Erbakan University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Jul 3, 2023
Registry last updated
Jul 3, 2023

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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