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Comparison of Mean Pain Between Pulpotomy and Pulpectomy in Patients with Symptomatic Irreversible Pulpitis: A Randomized Controlled Trial

Comparison of Mean Pain Between Pulpotomy and Pulpectomy in Patients with Symptomatic Irreversible Pulpitis: A Randomized Controlled Trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625000248460
Enrollment
584
Registered
2025-04-04
Start date
2025-04-12
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The Ethical Review Committee of Saidu Medical College has approved the study titled "Comparison of Mean Pain Between Pulpotomy and Pulpectomy: A Randomized Controlled Trial." This trial aims to compare post-treatment pain levels in patients with symptomatic irreversible pulpitis who undergo either pulpotomy (partial pulp removal) or pulpectomy (complete pulp removal). The study follows strict ethical guidelines, ensuring patient safety, confidentiality, and informed consent. With approval granted, data collection will be supervised by the Operative Dentistry Department, ensuring compliance with ethical and regulatory standards. The objective is to determine whether pulpotomy or pulpectomy offers better pain relief, with the hypothesis that there will be a significant difference in mean pain between the two treatments.

Interventions

1. Physical or Informational Materials Participants will be provided with a Visual Analogue Scale (VAS) to record their pain levels post-procedure. Standardized questionnaires will be given daily for seven days to assess post-operative discomfort. Radiographic examinations and clinical documentation will be recorded for diagnosis and treatment planning. Rubber dam, local anesthetic (Septodent- 2% Lidocaine, epinephrine 1:100000), hand K files (Mani- K Files), sodium hypochlorite (Tehnodent),

1. Physical or Informational Materials Participants will be provided with a Visual Analogue Scale (VAS) to record their pain levels post-procedure. Standardized questionnaires will be given daily for seven days to assess post-operative discomfort. Radiographic examinations and clinical documentation will be recorded for diagnosis and treatment planning. Rubber dam, local anesthetic (Septodent- 2% Lidocaine, epinephrine 1:100000), hand K files (Mani- K Files), sodium hypochlorite (Tehnodent), EDTA (PD -EDTA 17% Gel), and absorbent paper points (Meta BioMed) will be used during intervention procedures. 2. Procedures, Activities, and Processes Pulpotomy: The complete removal of coronal pulp, followed by the placement of a biocompatible material. Pulpectomy: Complete removal of pulp tissue, working length determination, chemomechanical preparation using the Step Back technique, and root canal filling with intracanal medications. Both procedures will involve local anesthesia, rubber dam isolation, and irrigation with sodium hypochlorite. 3. Intervention Providers and Their Expertise The intervention will be carried out by qualified dental practitioners from the Department of Operative Dentistry at Saidu College of Dentistry, Swat. The practitioners will have relevant experience in endodontic procedures, ensuring standardized and professional care. 4. Mode of Delivery The interventions will be provided in a face-to-face clinical setting. Each intervention will be conducted individually for each patient. 5. Number of Sessions, Schedule, and Duration Each participant will undergo a single treatment session (either pulpotomy or pulpectomy). Postoperative pain assessment will be conducted at 12 hours, 24 hours, and daily for seven days using the VAS scale. 6. Location of Intervention The study will be conducted at the Department of Operative Dentistry, Saidu College of Dentistry, Swat. Personalization, Adaptation, and Adherence The intervention is not personalized but follows a standardized protocol for both pulpotomy and pulpectomy groups. Adherence to the intervention will be assessed through follow-up calls at 24 hours post-procedure and daily pain assessments using the questionnaire. To maintain fidelity, trained practitioners will perform the interventions, ensuring consistent procedural steps.

Sponsors

self, Dr Faiz Ur Rahman,saidu college of Dentistry ,Swat
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
12 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

- Patients aged 12-65 years. - Diagnosed with symptomatic irreversible pulpitis based on clinical and radiographic findings

Exclusion criteria

Systemic diseases contraindicating dental procedures (e.g., MI, uncontrolled diabetes). - Pregnancy patients with apical periodontitis(pulpotomy can not be performed)

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026