Clinical trial NCT06803277: Post Operative Pain After Endodontic Retreatment
Official title: Evaluation of Post Operative Pain After a Single Session of Endodontic Retreatment Using Different Root Canal Sealers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retreatment
Keywords: endodontic retreatment
root canal sealer
post operative pain
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2025-01-31
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: a randomized clinical trial
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: the evaluation of post operative pain levels of the participants after used the different root canal sealers during endodontic retreatment endodontic retreatment
timeFrame: 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
measure: the evaluation of analgesic intake of the participants after used the different root canal sealers during endodontic retreatment
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Melikgazi
country: Turkey
facility: Erciyes University
state: Kayseri
city: Kayseri
country: Turkey
facility: Erciyes University
Study officials:
affiliation: TC Erciyes University
name: Salih DÜZGÜN, Associate Professor
role: STUDY_DIRECTOR
References:
citation: Gomes-Filho JE, Watanabe S, Cintra LT, Nery MJ, Dezan-Junior E, Queiroz IO, Lodi CS, Basso MD. Effect of MTA-based sealer on the healing of periapical lesions. J Appl Oral Sci. 2013;21(3):235-42. doi: 10.1590/1679-775720130089.
citation: Nosrat A, Dianat O, Verma P, Nixdorf DR, Law AS. Postoperative Pain: An Analysis on Evolution of Research in Half-Century. J Endod. 2021 Mar;47(3):358-365. doi: 10.1016/j.joen.2020.11.021. Epub 2020 Nov 30.
citation: Yaylali IE, Teke A, Tunca YM. The Effect of Foraminal Enlargement of Necrotic Teeth with a Continuous Rotary System on Postoperative Pain: A Randomized Controlled Trial. J Endod. 2017 Mar;43(3):359-363. doi: 10.1016/j.joen.2016.11.009.
citation: Fazlyab M, Esmaeili Shahmirzadi S, Esnaashari E, Azizi A, Moshari AA. Effect of low-level laser therapy on postoperative pain after single-visit root canal retreatment of mandibular molars: A randomized controlled clinical trial. Int Endod J. 2021 Nov;54(11):2006-2015. doi: 10.1111/iej.13608. Epub 2021 Aug 29.
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citation: Nagendrababu V, Duncan HF, Bjorndal L, Kvist T, Priya E, Jayaraman J, Pulikkotil SJ, Dummer PMH. PRIRATE 2020 guidelines for reporting randomized trials in Endodontics: explanation and elaboration. Int Endod J. 2020 Jun;53(6):774-803. doi: 10.1111/iej.13304. Epub 2020 May 9.
citation: Desai S, Chandler N. Calcium hydroxide-based root canal sealers: a review. J Endod. 2009 Apr;35(4):475-80. doi: 10.1016/j.joen.2008.11.026. Epub 2009 Feb 26.
citation: Ruparel NB, Ruparel SB, Chen PB, Ishikawa B, Diogenes A. Direct effect of endodontic sealers on trigeminal neuronal activity. J Endod. 2014 May;40(5):683-7. doi: 10.1016/j.joen.2014.01.030. Epub 2014 Mar 20.
citation: Zhang W, Peng B. Tissue reactions after subcutaneous and intraosseous implantation of iRoot SP, MTA and AH Plus. Dent Mater J. 2015;34(6):774-80. doi: 10.4012/dmj.2014-271.
citation: Yoldas O, Topuz A, Isci AS, Oztunc H. Postoperative pain after endodontic retreatment: single- versus two-visit treatment. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2004 Oct;98(4):483-7. doi: 10.1016/j.tripleo.2004.03.009.
citation: Arslan H, Doganay E, Karatas E, Unlu MA, Ahmed HMA. Effect of Low-level Laser Therapy on Postoperative Pain after Root Canal Retreatment: A Preliminary Placebo-controlled, Triple-blind, Randomized Clinical Trial. J Endod. 2017 Nov;43(11):1765-1769. doi: 10.1016/j.joen.2017.06.028. Epub 2017 Sep 28.
citation: Silva EJ, Menaged K, Ajuz N, Monteiro MR, Coutinho-Filho Tde S. Postoperative pain after foraminal enlargement in anterior teeth with necrosis and apical periodontitis: a prospective and randomized clinical trial. J Endod. 2013 Feb;39(2):173-6. doi: 10.1016/j.joen.2012.11.013. Epub 2012 Dec 23.
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