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

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

Recruiting
18-45 years
All
Phase N/A

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Overview

The aim of this study is to evaluate total pulpotomy, radicular pulpotomy, and root canal treatment procedures in mandibular premolar and/or molar teeth with symptomatic irreversible pulpitis, in terms of both their effectiveness in controlling postoperative pain and their success rates.

Materials and Methods: A total of 99 mandibular premolar and molar teeth will be used. The teeth will be divided into three groups, with 33 teeth in each group. The groups will consist of total pulpotomy, radicular pulpotomy, and root canal treatment.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.RP was performed to the level of a few millimeters deep 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.After the teeth are treated according to their assigned groups, pain intensity will be evaluated using the VAS scale at the following time points: preoperative, 12 hours, 24 hours, 48 hours, and 7 days postoperatively. The health status of the teeth will be assessed at 3, 6, and 12 months through clinical and radiographic examinations.

Description

Clinical Intervention An inferior alveolar nerve block will be administered to achieve anesthesia (4% articaine + 1:100,000 epinephrine .

After achieving rubber dam isolation, all caries in the tooth will be removed non-selectively using a high-speed sterile diamond bur under water cooling, followed by completion of the procedure with a sterile round bur attached to a low-speed handpiece.

The treatment will then proceed according to the protocol assigned to the patient's group-total pulpotomy, radicular pulpotomy, or root canal treatment.

Pulpotomy Procedure Group I: 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.

The exposed pulp surface will be irrigated with 5 mL of 2.5% sodium hypochlorite.

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.

Group II: 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.

MTA Application After hemostasis is achieved, the pulp chamber will be irrigated with 5 mL of 2.5% NaOCl.

MTA will be mixed according to the manufacturer's instructions. A 2-3 mm layer of MTA will be placed on the hemostatic pulp chamber floor. The MTA layer will be gently condensed with a moist cotton pellet, and then a moist cotton pellet will be placed over the MTA for 10 minutes.

Group III: 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.

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 placed in teeth that have undergone root canal treatment.

The tooth will then be restored using resin composite. The rubber dam will be removed, occlusal adjustments will be made, and the restoration will be finished and polished in the same appointment.

Postoperative radiographs will be taken immediately afterward, and patients will be instructed to return for follow-up at 3, 6, and 12 months, or earlier if symptoms develop.

Postoperative Pain Management The patient will be prescribed 400 mg ibuprofen tablets to be taken as needed. Patients will be instructed to record the frequency of analgesic intake in writing.

In cases of severe postoperative pain that does not subside with analgesics, the patient will be instructed to contact the operator immediately.

Evaluation Criteria and Follow-up Examination Pain Assessment Patients will be asked to record their pain before treatment (preoperative) and at 12 hours, 24 hours, 48 hours, and 7 days after treatment.

An 11-point Visual Analog Scale (VAS; 0 = no pain, 10 = unbearable pain) will be used.

The results will be documented by the patient at the corresponding time intervals on the pain record form provided.

Clinical and Radiographic Follow-up Patients will be recalled at 3, 6, and 12 months for clinical and radiographic examination.

During evaluation, it will be recorded whether the tooth is clinically and radiographically successful.

Clinical Success Criteria

  • Absence of spontaneous pain or discomfort beyond the first few days after treatment
  • No increased sensitivity to cold/heat
  • Mobility not exceeding Grade I
  • Healthy surrounding soft tissues (absence of swelling or sinus tract)
  • Negative response to axial palpation and percussion tests Radiographic Success Criteria
  • No increase in the Periapical Index (PAI) score at follow-up visits
  • Absence of extraradicular or intraradicular pathology
  • Absence of internal or external resorption Additional Evaluations

Restorative integrity:

The restorative integrity of each tooth will be assessed, and the need for re-restoration will be recorded.

Pulp sensitivity tests:

At each follow-up visit, pulp sensibility will be evaluated using cold testing and the electric pulp test.

Eligibility

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 details
    Post-operative Pain
    Pulpitis - Irreversible
    Success Rate

NCT07375576

Mustafa Kemal University

31 January 2026

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