Post Operative Pain After Endodontic Retreatment

NCT ID: NCT06803277

Last Updated: 2025-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-01

Study Completion Date

2024-01-07

Brief Summary

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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.

Detailed Description

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Conditions

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Retreatment

Keywords

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endodontic retreatment root canal sealer post operative pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

a randomized clinical trial
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Epoxy resin based sealer

AH plus

Group Type OTHER

endodontic retreatment

Intervention Type 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.

Calcium silicate based sealer

Sureseal

Group Type OTHER

endodontic retreatment

Intervention Type 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.

Calcium hydroxide based sealer

Sealapex

Group Type OTHER

endodontic retreatment

Intervention Type 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.

Interventions

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endodontic retreatment

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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TC Erciyes University

OTHER

Sponsor Role lead

Responsible Party

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Salih DÜZGÜN

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Salih DÜZGÜN, Associate Professor

Role: STUDY_DIRECTOR

TC Erciyes University

Locations

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Erciyes University

Melikgazi, Kayseri, Turkey (Türkiye)

Site Status

Erciyes University

Kayseri, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type RESULT
PMID: 23857649 (View on PubMed)

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.

Reference Type RESULT
PMID: 33271179 (View on PubMed)

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.

Reference Type RESULT
PMID: 28231975 (View on PubMed)

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.

Reference Type RESULT
PMID: 34383325 (View on PubMed)

Nagendrababu V, Duncan HF, Bjorndal L, Kvist T, Priya E, Jayaraman J, Pulikkotil SJ, Pigg M, Rechenberg DK, Vaeth M, Dummer PMH. PRIRATE 2020 guidelines for reporting randomized trials in Endodontics: a consensus-based development. Int Endod J. 2020 Jun;53(6):764-773. doi: 10.1111/iej.13294. Epub 2020 Apr 23.

Reference Type RESULT
PMID: 32196696 (View on PubMed)

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.

Reference Type RESULT
PMID: 32266988 (View on PubMed)

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.

Reference Type RESULT
PMID: 19345790 (View on PubMed)

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.

Reference Type RESULT
PMID: 24767564 (View on PubMed)

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.

Reference Type RESULT
PMID: 26632225 (View on PubMed)

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.

Reference Type RESULT
PMID: 15472665 (View on PubMed)

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.

Reference Type RESULT
PMID: 28967495 (View on PubMed)

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.

Reference Type RESULT
PMID: 23321226 (View on PubMed)

1. Silva EJNL, Menaged K, Ajuz N, Monteiro MRFP, de Souza Coutinho-Filho T. Postoperative pain after foraminal enlargement in anterior teeth with necrosis and apical periodontitis: a prospective and randomized clinical trial. Journal of endodontics 2013;39(2):173-176. 2. Arslan H, Doğanay E, Karataş E, Ünlü 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. Journal of endodontics 2017;43(11):1765-1769. 3. Yoldas O, Topuz A, Isçi AS, Oztunc H. Postoperative pain after endodontic retreatment: single-versus two-visit treatment. Oral Surgery, Oral Medicine, Oral Pathology, Oral Radiology, and Endodontology 2004;98(4):483-487. 4. Zhang W, Peng B. Tissue reactions after subcutaneous and intraosseous implantation of iRoot SP, MTA and AH Plus. Dental materials journal 2015;34(6):774-780. 5. Ruparel NB, Ruparel SB, Chen PB, Ishikawa B, Diogenes A. Direct effect of endodontic sealers on trigeminal neuronal activity. Journal of endodontics 2014;40(5):683-687. 6. Desai S, Chandler N. Calcium hydroxide-based root canal sealers: a review. Journal of endodontics 2009;35(4):475-480. 7. Lee B-N, Hong J-U, Kim S-M, Jang J-H, Chang H-S, Hwang Y-C, et al. Anti-inflammatory and osteogenic effects of calcium silicate-based root canal sealers. Journal of endodontics 2019;45(1):73-78. 8. Schäfer E, Bering N, Bürklein S. Selected physicochemical properties of AH Plus, EndoREZ and RealSeal SE root canal sealers. Odontology 2015;103:61-65. 9. Nagendrababu V, Duncan H, Bjørndal L, Kvist T, Priya E, Jayaraman J, et al. PRIRATE 2020 guidelines for reporting randomized trials in Endodontics: a consensus-based development. International Endodontic Journal 2020;53(6):764-773. 10. Nagendrababu V, Duncan H, Bjørndal L, Kvist T, Priya E, Jayaraman J, et al. PRIRATE 2020 guidelines for reporting randomized trials in Endodontics: explanation and elaboration. International endodontic journal 2020;53(6):774-803. 11. 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. International Endodontic Journal 2021;54(11):2006-2015. 12. 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. Journal of endodontics 2017;43(3):359-363. 13. Nosrat A, Dianat O, Verma P, Nixdorf DR, Law AS. Postoperative pain: an analysis on evolution of research in half-century. Journal of Endodontics 2021;47(3):358-365. 14. Gomes-Filho JE, Watanabe S, Cintra LTA, Nery MJ, Dezan-Junior E, Queiroz IOA, et al. Effect of MTA-based sealer on the healing of periapical lesions. Journal of applied oral science 2013;21(3):235-242.

Reference Type RESULT

Duzgun S, Albayrak H, Topcuoglu HS. Evaluation of the effects of calcium hydroxide-based, calcium silicate-based, and epoxy resin-based sealers on postoperative pain after a single session non-surgical endodontic retreatment: a randomized clinical trial. BMC Oral Health. 2025 Oct 9;25(1):1583. doi: 10.1186/s12903-025-06961-9.

Reference Type DERIVED
PMID: 41068727 (View on PubMed)

Other Identifiers

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2021/306

Identifier Type: -

Identifier Source: org_study_id