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Completed

NCT Number: NCT06803277

Post Operative Pain After Endodontic Retreatment

Clinical Trial The aim of this clinical study was to evaluate the effect of different root canal sealers on post operative pain after a single session endodontic retreatment of the teeth have single root and canal with chronic apical periodontitis.

The main questions aimed to be answered are:

Which of the patients treated with AHplus, Sureseal and Sealapex root canal sealers had more postoperative pain after endodontic retreatment?

Which of the patients that treated with AHplus, Sureseal and Sealapex root canal sealers required more analgesic intake after endodontic retreatment?

Participants:

Undergo a single session of endodontic retreatment using one of AH plus, Sureseal or Sealapex root canal sealers.

Visit the clinic one week later after endodontic retreatment Write the condition of analgesic intake and pain score at 6, 12, 24 hours and 2, 3, 4, 5, 6 and 7 days after treatment using a visual analog scale.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erciyes University, Melikgazi, Kayseri, Turkey (Türkiye)

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients who did not have any systemic disease, pregnancy or breastfeeding,
  • Patients who were older than 18 years,
  • Patients who had not used analgesics, anti-inflammatory or antibiotics in the last 7 days and cortisone in the last 6 months,
  • Patients who had improved communication skills and were at a mental level to express pain scoring clearly,
  • Patients who did not have bruxism problem or primary contact were included in the study.
  • Teeth with more than 60% of the root canal filled have preoperatively asymptomatic single root and single canal with previous root canal treatment and chronic apical periodontitis and periapical index (PAI) scores 2-4

Exclusion criteria

  • Teeth had root resorption,
  • Teeth had crown damage
  • Teeth had severe malocclusion,
  • Teeth had PAI scores 1 and 5
  • Immature teeth

Treatment and study plan

Endodontic Retreatment

Procedure

Root canal retreatment is recommended when endodontic disease persists or develops after root canal treatment. Root canal retreatment is believed to be the elimination of the main causes of treatment failure.

Primary outcomes

  1. the evaluation of post operative pain levels of the participants after used the different root canal sealers during endodontic retreatment endodontic retreatment

    Time frame: Postoperative pain was assessed using a visual analog scale (VAS) at 6 hours,12 hours, 24 hours, 48 hours, 72 hours, 4,5,6 and 7 days after the end of the retreatment.The VAS was a 100 mm horizontal scale with marks every 10 mm

    The time when the retreatment is completed is considered the start time ( 0 h).Postoperative pain was assessed using a VAS at 6 hours,12 hours, 24 hours, 48 hours, 72 hours, 4,5,6 and 7 days after the end of the retreatment.The VAS was a 100 mm horizontal scale with marks every 10 mm and no numbers except a 0 at the beginning of the scale and a 10 at the end.An investigator blinded to the study groups trained all participants to use the scale.The pain levels were classified as no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), or severe pain (75- 100 mm).

  2. the evaluation of analgesic intake of the participants after used the different root canal sealers during endodontic retreatment

    Time frame: Participants were asked to note whether they took 400 mgr ibuprofen at 6 hours,12 hours, 24 hours, 48 hours, 72 hours, 4,5,6 and 7 days after the end of the retreatment as score 1 or score 2

    The time when the retreatment is completed is considered the start time ( 0 h). Score 1: If the participant did not need analgesic a medicine(400 mgr ibuprofen ) after the retreatment, the participant was told to mark a score of 1.

    Score 2: If the participant needed analgesic a medicine (400 mgr ibuprofen ) after the retreatment, the participant was told to mark a score of 2.

Sponsors and collaborators

Lead sponsor

TC Erciyes University

Other

Registry information

Official study title

Evaluation of Post Operative Pain After a Single Session of Endodontic Retreatment Using Different Root Canal Sealers

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Jan 31, 2025
Registry last updated
Jan 31, 2025

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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