Outcomes of Pulpotomy and Root Canal Treatment in Teeth With Symptomatic Irreversible Pulpitis

NCT07375576 | Recruiting

• 1 other identifier: 2314
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the clinical effectiveness of total pulpotomy (TP), radicular pulpotomy (RP), and root canal treatment (RCT) in mandibular premolar and/or molar teeth diagnosed with symptomatic irreversible pulpitis, with respect to postoperative pain control and treatment success.Materials and Methods:A total of 99 mandibular premolar and molar teeth will be included in this study. The teeth will be randomly allocated into three groups (n = 33 per group): total pulpotomy, radicular pulpotomy, and root canal treatment.Root canal treatment will be performed using standardized endodontic protocols.Total pulpotomy will be carried out to the level of the canal orifices, followed by hemostasis achieved with 2.5% sodium hypochlorite (NaOCl). A 3-mm-thick layer of mineral trioxide aggregate (MTA) will be placed as the pulpotomy material.Radicular pulpotomy will be performed by removing the pulp tissue a few millimeters apical to the canal orifices. Hemostasis will be achieved using 2.5% NaOCl, and a 3-mm-thick layer of MTA will be placed as the pulpotomy agent.All treated teeth will be restored with glass ionomer cement, followed by a composite resin restoration.Postoperative pain intensity will be assessed using a visual analog scale (VAS) at the following time points: preoperatively, and at 12 hours, 24 hours, 48 hours, and 7 days postoperatively. Clinical and radiographic evaluations will be performed at 3, 6, and 12 months to assess treatment success and periapical health.

Conditions

Success Rate; Post-operative Pain; Pulpitis - Irreversible

Keywords

irreversibl pulpitis; total pulpotomy; radicular pulpotomy; vital pulp therapy (VPT); root canal treatment (RCT); pain assessment; vas scale; clinical follow - up; radiographic evaluation

Outcome Measures

Primary Outcomes (2)

• Periapical healing

  Radiographic periapical status will be assessed using the Periapical Index (PAI) according to Ørstavik et al., with scores ranging from 1 (normal periapical structures) to 5 (severe apical periodontitis), based on the degree of periapical radiolucency. The primary outcome will be periapical lesion healing, evaluated by changes in periapical index (PAI) scores on periapical radiographs taken before treatment and at the 12-month follow-up.

  1 year

• 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 (3)

Total Pulpotomy

EXPERIMENTAL

After the access cavity is prepared, the vitality of the pulp will be visually confirmed. The coronal pulp tissue will be removed using a high-speed sterile diamond bur with copious water cooling. A cotton pellet moistened with 2.5% NaOCl will be applied to the pulp chamber. If necessary, this procedure will be repeated for up to 10 minutes. The time required to achieve hemostasis will be recorded.

Procedure: Total Pulpotomy

Radicular Pulpotomy

EXPERIMENTAL

Inflamed coronal pulp tissue will be removed using a large sterile round bur on a high-speed handpiece with air-water spray, down to the level of the canal orifices. The canal orifices will be located, and the depth of the pulp chamber will be measured using a Williams probe. A sterile long-shank round carbide bur will be marked with an endodontic file stopper (pulp chamber depth + 3 mm), and radicular pulp tissue will be removed from the canal orifice level to approximately 2-3 mm apical depth. Small cotton pellets moistened with 2.5% NaOCl will be individually placed into each canal orifice, down to the level of pulp excision; if necessary, the procedure will be repeated for up to 10 minutes. The time required to achieve hemostasis will be recorded.

Procedure: Radicular pulpotomy

Root Canal Treatment Procedure

ACTIVE COMPARATOR

After the access cavity is prepared, the vitality of the pulp will be visually confirmed. Once the canal orifices are located, the working length (WL) will be determined using a No. 10 K-file and an apex locator, and then confirmed radiographically. Chemomechanical preparation will be performed to the working length using Reciproc files. After every three pecking motions, the root canals will be irrigated with 2.5% NaOCl. The final irrigation sequence will be as follows: * 5 mL of 17% EDTA for 1 minute * 5 mL of distilled water * 5 mL of 2.5% NaOCl maintained in the canal for 1 minute * 5 mL of distilled water (to neutralize NaOCl) After irrigation, canals will be dried with sterile paper points and obturated in a single visit using a calcium silicate-based sealer.

Procedure: Root canal treatment

Interventions

Total Pulpotomy PROCEDURE

Total pulpotomy procedures explained in arm descriptions.

Total Pulpotomy

Radicular pulpotomy PROCEDURE

Radicular pulpotomy procedures explained in arm descriptions.

Radicular Pulpotomy

Root canal treatment PROCEDURE

Root canal treatment procedures explained in arm descriptions.

Root Canal Treatment Procedure

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• The patients included in the study must have restorable, extremely deep carious lesions in the mandibular first and second molars, and first and second premolars; healthy periodontal status (periodontal pocket ≤ 3 mm); and a clinical diagnosis of symptomatic irreversible pulpitis (history of spontaneous pain, pain persisting after removal of the stimulus, exaggerated and prolonged response to cold testing, and a positive response to the electric pulp test).

You may not qualify if:

• Teeth with cracks or cusp fractures, subgingival caries, or periapical radiolucency will not be included in the study.
• Informed consent will be obtained from all included patients.

Sponsors & Collaborators

• Mustafa Kemal University: lead

Study Sites (1)

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

Hatay, Antakya, 31000, Turkey (Türkiye)

RECRUITING

Related Publications (13)

• Zhu L, Liu W, Deng X, Chen Z, Chen J, Qian W. Full pulpotomy versus root canal therapy in mature teeth with irreversible pulpitis: a randomized controlled trial. BMC Oral Health. 2024 Oct 16;24(1):1231. doi: 10.1186/s12903-024-05011-0.

  PMID: 39415163 BACKGROUND

• Taha NA, Abuzaid AM, Khader YS. A Randomized Controlled Clinical Trial of Pulpotomy versus Root Canal Therapy in Mature Teeth with Irreversible Pulpitis: Outcome, Quality of Life, and Patients' Satisfaction. J Endod. 2023 Jun;49(6):624-631.e2. doi: 10.1016/j.joen.2023.04.001. Epub 2023 Apr 19.

  PMID: 37080387 BACKGROUND

• Shah A, Pv A, Sharma S, Kumar V, Chawla A, Logani A. The outcome of full and deep pulpotomy in teeth with extremely deep carious lesion and symptomatic irreversible pulpitis: A non-inferiority randomized controlled trial. Int Endod J. 2025 May;58(5):715-726. doi: 10.1111/iej.14205. Epub 2025 Jan 31.

  PMID: 39887741 BACKGROUND

• Ricucci D, Siqueira JF Jr, Abdelsayed RA, Lio SG, Rocas IN. Bacterial Invasion of Pulp Blood Vessels in Teeth with Symptomatic Irreversible Pulpitis. J Endod. 2021 Dec;47(12):1854-1864. doi: 10.1016/j.joen.2021.09.010. Epub 2021 Sep 29.

  PMID: 34597722 BACKGROUND

• Moreno JO, Alves FR, Goncalves LS, Martinez AM, Rocas IN, Siqueira JF Jr. Periradicular status and quality of root canal fillings and coronal restorations in an urban Colombian population. J Endod. 2013 May;39(5):600-4. doi: 10.1016/j.joen.2012.12.020. Epub 2013 Feb 15.

  PMID: 23611376 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

• 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

• European Society of Endodontology (ESE) developed by:; Duncan HF, Galler KM, Tomson PL, Simon S, El-Karim I, Kundzina R, Krastl G, Dammaschke T, Fransson H, Markvart M, Zehnder M, Bjorndal L. European Society of Endodontology position statement: Management of deep caries and the exposed pulp. Int Endod J. 2019 Jul;52(7):923-934. doi: 10.1111/iej.13080.

  PMID: 30664240 BACKGROUND

• Duncan HF. Present status and future directions-Vital pulp treatment and pulp preservation strategies. Int Endod J. 2022 May;55 Suppl 3(Suppl 3):497-511. doi: 10.1111/iej.13688. Epub 2022 Feb 3.

  PMID: 35080024 BACKGROUND

• Demant S, Dabelsteen S, Bjorndal L. A macroscopic and histological analysis of radiographically well-defined deep and extremely deep carious lesions: carious lesion characteristics as indicators of the level of bacterial penetration and pulp response. Int Endod J. 2021 Mar;54(3):319-330. doi: 10.1111/iej.13424. Epub 2020 Nov 18.

  PMID: 33012046 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

• Asgary S, Eghbal MJ, Shahravan A, Saberi E, Baghban AA, Parhizkar A. Outcomes of root canal therapy or full pulpotomy using two endodontic biomaterials in mature permanent teeth: a randomized controlled trial. Clin Oral Investig. 2022 Mar;26(3):3287-3297. doi: 10.1007/s00784-021-04310-y. Epub 2021 Dec 2.

  PMID: 34854987 BACKGROUND

• Asgary S, Eghbal MJ. The effect of pulpotomy using a calcium-enriched mixture cement versus one-visit root canal therapy on postoperative pain relief in irreversible pulpitis: a randomized clinical trial. Odontology. 2010 Jul;98(2):126-33. doi: 10.1007/s10266-010-0127-2. Epub 2010 Jul 23.

  PMID: 20652790 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Efkan Aksay

CONTACT

+905062654889; efkanaksay@gmail.com

Merve Sarı, DDS

CONTACT

+905546430401; sarimerve94@outlook.com

Study Design

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

Model Details: This study is designed as a prospective, parallel-group, double-blind, randomized controlled clinical trial.

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: January 29, 2026
• Study Start: December 1, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: June 5, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)