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

June 4, 2026 updated by: Merve Sari, Mustafa Kemal University

Evaluation of the Outcomes of Total Pulpotomy, Radicular Pulpotomy, and Root Canal Treatment in Teeth With Extremely Deep Caries and Symptomatic Irreversible Pulpitis

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Clinical Intervention: Local anesthesia will be achieved using an inferior alveolar nerve block with 4% articaine containing 1:100,000 epinephrine. Following rubber dam isolation, all carious tissue will be removed non-selectively using a sterile high-speed diamond bur under water cooling. Caries removal will be completed with a sterile round bur in a low-speed handpiece. Subsequently, treatment will be carried out according to the protocol assigned to the patient's group: total pulpotomy, radicular pulpotomy, or root canal treatment.Group I Total Pulpotomy: After access cavity preparation, pulp vitality will be visually confirmed. The coronal pulp tissue will be completely removed using a sterile high-speed diamond bur with copious water irrigation. The exposed pulp surface will be irrigated with 5 mL of 2.5% sodium hypochlorite (NaOCl). Hemostasis will be attempted by placing a cotton pellet moistened with 2.5% NaOCl onto the pulp chamber floor. If necessary, this procedure will be repeated for up to 10 minutes. The time required to achieve hemostasis will be recorded.

Group II Radicular Pulpotomy: Inflamed coronal pulp tissue will be removed using a large sterile round bur mounted on a high-speed handpiece with air-water spray, extending to the level of the canal orifices. The canal orifices will be identified, and the depth of the pulp chamber will be measured using a Williams periodontal probe. A sterile long-shank round carbide bur will be marked with an endodontic file stopper corresponding to the pulp chamber depth plus 3 mm. Radicular pulp tissue will then be removed to a depth of approximately 2-3 mm apical to the canal orifices.Small cotton pellets moistened with 2.5% NaOCl will be individually placed into each canal orifice at the level of pulp excision to achieve hemostasis. If necessary, this step will be repeated for up to 10 minutes. The time required to achieve hemostasis will be recorded.MTA Application (Groups I and II): After achieving hemostasis, the pulp chamber will be irrigated with 5 mL of 2.5% NaOCl. Mineral trioxide aggregate (MTA) will be mixed according to the manufacturer's instructions and placed as a 2-3 mm thick layer over the pulp chamber floor. The material will be gently condensed using a moist cotton pellet, after which a moist cotton pellet will be placed over the MTA for 10 minutes.Group III Root Canal Treatment: Following access cavity preparation, pulp vitality will be visually confirmed. The canal orifices will be located, and the working length (WL) will be determined using a size 10 K-file and an electronic apex locator, then verified radiographically. Chemomechanical preparation will be performed to the working length using Reciproc files. During instrumentation, root canals will be irrigated with 2.5% NaOCl after every three pecking motions. The final irrigation protocol will consist of: 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, the canals will be dried with sterile paper points and obturated in a single visit using a calcium silicate-based sealer.

Final Restoration: A 2-3 mm layer of resin-modified glass ionomer cement (RMGIC) will be placed over the MTA and light-cured for 20 seconds. RMGIC will also be applied in teeth that have undergone root canal treatment. All teeth will then be restored with resin composite. The rubber dam will be removed, occlusal adjustments will be performed, and the restorations will be finished and polished during the same appointment. Postoperative periapical radiographs will be obtained immediately after treatment. Patients will be recalled for follow-up examinations at 3, 6, and 12 months, or earlier if symptoms occur. Postoperative Pain Management: Patients will be prescribed 400 mg ibuprofen tablets to be taken as needed. They will be instructed to record the frequency of analgesic intake in writing. In cases of severe postoperative pain unresponsive to analgesics, patients will be instructed to contact the operator immediately. Evaluation Criteria and Follow-up Examination Pain Assessment: Patients will record their pain intensity preoperatively and at 12 hours, 24 hours, 48 hours, and 7 days postoperatively using an 11-point visual analog scale (VAS), where 0 represents no pain and 10 represents unbearable pain. Pain scores will be documented by the patients on standardized pain record forms. Clinical and Radiographic Follow-up: Clinical and radiographic evaluations will be performed at 3, 6, and 12 months to assess treatment success.Clinical success criteria will include: Absence of spontaneous pain or discomfort beyond the initial postoperative period, no increased sensitivity to thermal stimuli, tooth mobility not exceeding Grade I, healthy surrounding soft tissues, with no swelling or sinus tract, negative response to percussion and palpation tests. Radiographic success criteria will include: No increase in Periapical Index (PAI) scores at follow-up ,absence of intra- or extraradicular pathology, absence of internal or external root resorption.

Additional Evaluations: Restorative integrity will be assessed at each follow-up visit, and the need for re-restoration will be recorded, pulp sensibility will be evaluated using cold testing and an electric pulp test at all follow-up appointments.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
99

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

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Study Contact Backup

Study Locations

  • Turkey (Türkiye)
    • Antakya
      • Hatay, Antakya, Turkey (Türkiye), 31000
        • Recruiting
        • Department of Endodontics, Faculty of Dentistry, Hatay Mustafa Kemal University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy patients of both sexes, aged between 15 and 45 years, with no systemic diseases, will be screened for inclusion in the study. Strict eligibility criteria will be applied.

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).

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Total Pulpotomy

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
Total pulpotomy procedures explained in arm descriptions.
Experimental: Radicular Pulpotomy

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
Radicular pulpotomy procedures explained in arm descriptions.
Active Comparator: Root Canal Treatment Procedure

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
Root canal treatment procedures explained in arm descriptions.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Periapical healing
Time Frame: 1 year
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
Time Frame: 1 week

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mustafa Kemal University

Publications and helpful links

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General Publications

Study record dates

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Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 21, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 29, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2314

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan to share IPD due to confidentiality and privacy considerations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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