Evaluation of Post-operative Pain After Total Pulpotomy and Root Canal Treatment

NCT05923619 | Completed

• 1 other identifier: 2308
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to compare post-operative pain following total pulpotomy (TP) and root canal treatment (RCT) in mature molar teeth with severe symptoms indicative of irreversible pulpitis. To compare the traditional pulpitis classification with the Wolters system in evaluating post-operative pain. Materials and Methods: Sixty-four mature mandibular molar with symptomatic vital pulps in patients aged 18-60 years were included and were classified according to the Wolters (moderate/severe pulpitis) and the traditional pulpitis classification (reversible/irreversible pulpitis). The teeth randomly divided into 2 groups. RCT was performed, using standardized protocols. TP was performed to the level of the canal orifices, and haemostasis was achieved with 2.5% NaOCl. 3 mm layer of MTA was placed as the pulpotomy agent. The treated teeth were restored with glass ionomer cement followed by composite. Pain was recorded 6, 12, 24, 48, 72 hours and 7 days after treatment. The data collected were statistically analyzed

Conditions

Post-operative Pain; Pulpitis - Irreversible

Keywords

irreversibl pulpitis; mineral trioxide aggregate; post-operative pain; total pulpotomy

Outcome Measures

Primary Outcomes (1)

• post-operative pain

  Pre-operative and post-operative pain scores were determined according to the Heft-Parker Visual Analog Scale (HP VAS), which consisted of a 10 mm long horizontal line where numerical values were divided into visual categories. Patients were instructed to score their pain with a value on the HP VAS. The presence or absence of pain was classified according to 4 categories: No pain (level 1, 0), Mild pain (level 2, 1-3 mm), Moderate pain (level 3, 4-6mm), Severe pain (level 4, 7-10 mm).

  1 week

Study Arms (2)

Total pulpotomy

EXPERIMENTAL

The coronal pulp tissue was completely removed with a high-speed sterile carbide bur under abundant water coolant. A cotton pellet moistened with 2.5% sodium hypochlorite was used to achieve hemostasis. Following the achievement of hemostasis, an average of 3 mm thick MTA material (Angelus, Londrina, PR, Brazil) was used to cover the pulp chamber. In the same session, the pulp chamber was closed with approximately 2 mm thick flowable glass ionomer cement (Glass Liner, WP), and coronal restoration was completed with composite filling (Estelıte® Sıgma Quıck, Tokuyama).

Procedure: Total pulpotomy

Root canal treatment

ACTIVE COMPARATOR

The working length was determined using a 15 K type file and apex locator (Morita Root ZX, Tokyo, Japan) and checked by radiography. The chemomechanical preparation was completed using the R25 (Resiproc, VDW, Munich, Germany) file in the mesial root canals and the R25, R40, and R50 files in the distal root canals, respectively, at the WL. During the chemomechanical preparation, the root canals were irrigated with 2.5% NaOCl after every three pecking motions; and total volume of NaOCl was 10 ml. In the final irrigation, the root canal was irrigated with 5 ml 17% Ethylene diamine tetraacetic acid (EDTA), for 1 minute, following with 2 ml distilled water. Following the retention of 5 ml of 2.5% NaOCl in the root canal for 1 minute, 5 ml of distilled used to neutralize the effect of NaOCl in the root canal.Tthe root canals were filled with the lateral condensation using epoxy-resin-based sealer (AH Plus, Dentsply DeTrey GmbH, Konstanz, Germany).

Procedure: Root canal treatment

Interventions

Total pulpotomy PROCEDURE

Total pulpotomy procedures explained in arm descriptions.

Total pulpotomy

Root canal treatment PROCEDURE

Root canal treatment procedures explained in arm descriptions.

Root canal treatment

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Standard periodontal pocket depth and mobility,
• Deep/extreme deep caries (periapical radiography),
• Diagnosed with moderate and severe pulpitis according to the Wolters classification,
• Had a positive response to the cold test,
• Mandibular first and second molar teeth with completed root development.

You may not qualify if:

• Patients who had received antibiotic therapy in the last three months or used non-steroidal anti-inflammatory drugs within the last twelve hours,
• Patients with diabetes or immunosuppressive disease or pregnancy,
• Teeth that cannot be restored or require post-core,
• Sinus tract or abscess,
• Did not respond to pulp sensitivity test (cold test),
• Teeth with no exposed pulp after non-selective caries removal.

Sponsors & Collaborators

• Mustafa Kemal University: lead

Study Sites (1)

Department of Endodontics, Faculty of Dentistry, Hatay Mustafa Kemal University

Hatay, Antakya, 31000, Turkey (Türkiye)

Location

Related Publications (10)

• Sabeti M, Huang Y, Chung YJ, Azarpazhooh A. Prognosis of Vital Pulp Therapy on Permanent Dentition: A Systematic Review and Meta-analysis of Randomized Controlled Trials. J Endod. 2021 Nov;47(11):1683-1695. doi: 10.1016/j.joen.2021.08.008. Epub 2021 Sep 1.

  PMID: 34478787 BACKGROUND

• Levin LG, Law AS, Holland GR, Abbott PV, Roda RS. Identify and define all diagnostic terms for pulpal health and disease states. J Endod. 2009 Dec;35(12):1645-57. doi: 10.1016/j.joen.2009.09.032.

  PMID: 19932339 BACKGROUND

• Ricucci D, Russo J, Rutberg M, Burleson JA, Spangberg LS. A prospective cohort study of endodontic treatments of 1,369 root canals: results after 5 years. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2011 Dec;112(6):825-42. doi: 10.1016/j.tripleo.2011.08.003.

  PMID: 22099859 BACKGROUND

• Taha NA, Al-Rawash MH, Imran ZA. Outcome of full pulpotomy in mature permanent molars using 3 calcium silicate-based materials: A parallel, double blind, randomized controlled trial. Int Endod J. 2022 May;55(5):416-429. doi: 10.1111/iej.13707. Epub 2022 Mar 17.

  PMID: 35152464 BACKGROUND

• Careddu R, Duncan HF. A prospective clinical study investigating the effectiveness of partial pulpotomy after relating preoperative symptoms to a new and established classification of pulpitis. Int Endod J. 2021 Dec;54(12):2156-2172. doi: 10.1111/iej.13629. Epub 2021 Sep 26.

  PMID: 34490637 BACKGROUND

• Wolters WJ, Duncan HF, Tomson PL, Karim IE, McKenna G, Dorri M, Stangvaltaite L, van der Sluis LWM. Minimally invasive endodontics: a new diagnostic system for assessing pulpitis and subsequent treatment needs. Int Endod J. 2017 Sep;50(9):825-829. doi: 10.1111/iej.12793. No abstract available.

  PMID: 28776717 BACKGROUND

• Parirokh M, Torabinejad M, Dummer PMH. Mineral trioxide aggregate and other bioactive endodontic cements: an updated overview - part I: vital pulp therapy. Int Endod J. 2018 Feb;51(2):177-205. doi: 10.1111/iej.12841. Epub 2017 Sep 21.

  PMID: 28836288 BACKGROUND

• Ramani A, Sangwan P, Tewari S, Duhan J, Mittal S, Kumar V. Comparative evaluation of complete and partial pulpotomy in mature permanent teeth with symptomatic irreversible pulpitis: A randomized clinical trial. Int Endod J. 2022 May;55(5):430-440. doi: 10.1111/iej.13714. Epub 2022 Mar 10.

  PMID: 35226769 BACKGROUND

• Galani M, Tewari S, Sangwan P, Mittal S, Kumar V, Duhan J. Comparative Evaluation of Postoperative Pain and Success Rate after Pulpotomy and Root Canal Treatment in Cariously Exposed Mature Permanent Molars: A Randomized Controlled Trial. J Endod. 2017 Dec;43(12):1953-1962. doi: 10.1016/j.joen.2017.08.007. Epub 2017 Oct 20.

  PMID: 29061359 BACKGROUND

• Sari M, Yilmaz K, Ozyurek T. Postoperative pain after total pulpotomy and root canal treatment in mature molars according to the new and traditional classifications of pulpitis: a prospective, randomized controlled trial. BMC Oral Health. 2024 Sep 12;24(1):1075. doi: 10.1186/s12903-024-04836-z.

  PMID: 39266985 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Merve Sarı, DDS

  Department of Endodontics, Faculty of Dentistry, Hatay Mustafa Kemal University

  PRINCIPAL INVESTIGATOR

• Koray Yılmaz

  Department of Endodontics, Faculty of Dentistry, Hatay Mustafa Kemal University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 16, 2023
• First Posted: June 28, 2023
• Study Start: January 13, 2023
• Primary Completion: October 6, 2023
• Study Completion: October 13, 2023
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)