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Trial · NCT07889050

Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryPostoperative pain assessed by Visual Analog Scale (VAS)24 hours after root canal treatment
Postoperative pain will be self-assessed by participants using a 100 mm Visual Analog Scale (VAS), consisting of a horizontal line where participants mark the point that best represents their level of pain intensity. The left end (0 mm) indicates "no pain" and the right end (100 mm) indicates "the most severe pain I have ever felt in my life." Scores are measured in millimeters, with higher scores indicating greater pain intensity. Participants will record their VAS score in a standardized pain diary at each assessment time point, along with any rescue analgesic (paracetamol 500 mg) use, including time and dose, and any adverse events or unexpected occurrences. A blinded researcher, unaware of group allocation, will telephone participants at each designated time point to record pain scores and remind them to complete the diary.
SecondaryPostoperative pain assessed by Visual Analog Scale (VAS) at 6 Hours6 hours after root canal treatment
Postoperative pain will be self-assessed using a 100 mm Visual Analog Scale (VAS). The left end (0 mm) indicates "no pain" and the right end (100 mm) indicates "the most severe pain I have ever felt in my life." Higher scores indicate greater pain intensity.
SecondaryPostoperative pain assessed by Visual Analog Scale (VAS) at 12 Hours12 hours after root canal treatment
Postoperative pain will be self-assessed using a 100 mm Visual Analog Scale (VAS). The left end (0 mm) indicates "no pain" and the right end (100 mm) indicates "the most severe pain I have ever felt in my life." Higher scores indicate greater pain intensity.
SecondaryPostoperative pain assessed by Visual Analog Scale (VAS) at 48 Hours48 hours after root canal treatment
Postoperative pain will be self-assessed using a 100 mm Visual Analog Scale (VAS). The left end (0 mm) indicates "no pain" and the right end (100 mm) indicates "the most severe pain I have ever felt in my life." Higher scores indicate greater pain intensity.
SecondaryPostoperative pain assessed by Visual Analog Scale (VAS) at 72 Hours72 hours after root canal treatment
Postoperative pain will be self-assessed using a 100 mm Visual Analog Scale (VAS). The left end (0 mm) indicates "no pain" and the right end (100 mm) indicates "the most severe pain I have ever felt in my life." Higher scores indicate greater pain intensity.
SecondaryPostoperative pain assessed by Visual Analog Scale (VAS) at 7 Days7 days (168 hours) after root canal treatment
Postoperative pain will be self-assessed using a 100 mm Visual Analog Scale (VAS). The left end (0 mm) indicates "no pain" and the right end (100 mm) indicates "the most severe pain I have ever felt in my life." Higher scores indicate greater pain intensity.
SecondaryPain Catastrophizing as Assessed by Pain Catastrophizing Scale (PCS)Baseline, prior to root canal treatment
Pain catastrophizing will be assessed using the Pain Catastrophizing Scale (PCS), a validated self-report questionnaire measuring the tendency to exaggerate the threat value of pain. Higher scores indicate greater pain catastrophizing.
SecondaryDental anxiety assessed by Modified Dental Anxiety Scale (MDAS)Baseline, prior to root canal treatment
Dental anxiety will be assessed using the Modified Dental Anxiety Scale (MDAS), a validated self-report questionnaire measuring anxiety related to dental treatment. Higher scores indicate greater dental anxiety.
SecondarySalivary irisin level at baselineBaseline, prior to root canal treatmentSalivary irisin concentration will be measured in unstimulated saliva samples collected using the passive drooling method, analyzed by enzyme-linked immunosorbent assay (ELISA).
SecondarySalivary irisin level at 24 Hours24 hours after root canal treatmentSalivary irisin concentration will be measured in unstimulated saliva samples collected using the passive drooling method, analyzed by enzyme-linked immunosorbent assay (ELISA).
SecondarySalivary irisin level at 72 Hours72 hours after root canal treatmentSalivary irisin concentration will be measured in unstimulated saliva samples collected using the passive drooling method, analyzed by enzyme-linked immunosorbent assay (ELISA).
SecondarySalivary irisin level in healthy reference groupAt the time of saliva sample collection, single time point
Salivary irisin concentration will be measured in a single unstimulated saliva sample collected from healthy participants without an indication for root canal treatment, using the passive drooling method and analyzed by enzyme-linked immunosorbent assay (ELISA), to establish normative reference values.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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