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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorMustafa Kemal University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

Teeth with cracks or cusp fractures, subgingival caries, or periapical radiolucency will not be included in the study.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Total Pulpotomy

    Procedure/Surgery

    Total pulpotomy procedures explained in arm descriptions.

  • Radicular pulpotomy

    Procedure/Surgery

    Radicular pulpotomy procedures explained in arm descriptions.

  • Root canal treatment

    Procedure/Surgery

    Root canal treatment procedures explained in arm descriptions.

Treatment groups

99 Participants
are divided into 3 treatment groups
Group A: Total PulpotomyExperimental treatment 1 intervention
Group B: Radicular PulpotomyExperimental treatment 1 intervention
Group C: Root Canal Treatment ProcedureActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
1 year
2

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).

Time frame
1 week

Secondary outcomes

Other outcomes

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