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RetreatmentNCT06803277

Post Operative Pain After Endodontic Retreatment

A study testing endodontic retreatment in people with Retreatment, run by TC Erciyes University at 2 sites in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Retreatment
What is being tested?
endodontic retreatment
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
86 participants
Where
2 sitesTurkey (Türkiye)
Study dates
1 May 2021to 7 Jan 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Turkey (Türkiye)2 sites
  • Erciyes University

    Kayseri, 38039

  • Erciyes University

    Melikgazi, Kayseri, 38039

Other trials in Turkey (Türkiye)

About this study

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

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:

Read more

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.

Conditions
Retreatment
Being tested
endodontic retreatment
Keywords
endodontic retreatment, root canal sealer, post operative pain
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • endodontic retreatmentProcedure or surgery

    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.

Study groups in NCT06803277
Study groupRoleWhat they receive
Epoxy resin based sealerOtherAH plus
Receives: Procedure: endodontic retreatment
Calcium silicate based sealerOtherSureseal
Receives: Procedure: endodontic retreatment
Calcium hydroxide based sealerOtherSealapex
Receives: Procedure: endodontic retreatment

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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).

    Measured: 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

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

    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.

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2025
  2. Study start1 May 2021
  3. Primary completion31 Dec 2023
  4. Study completion7 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
a randomized clinical trial
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
86 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06803277
Sponsor's protocol ID
2021/306
Status last verified
Jan 2025
First submitted
17 Jan 2025
Last updated
31 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 23857649
  • 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.

    PubMed 33271179
  • 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.

    PubMed 28231975
  • 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.

    PubMed 34383325
  • 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.

    PubMed 32196696
  • 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.

    PubMed 32266988
  • 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.

    PubMed 19345790
  • 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.

    PubMed 24767564
  • 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.

    PubMed 26632225
  • 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.

    PubMed 15472665
  • 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.

    PubMed 28967495
  • 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.

    PubMed 23321226
  • 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.

  • 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.

    PubMed 41068727

Questions about this trial

What is this clinical trial studying?

A study testing endodontic retreatment in people with Retreatment, run by TC Erciyes University at 2 sites in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06803277, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2025; AzTrials last refreshed its copy on 31 Oct 2026.

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