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Postoperative Pain After Full Pulpotomy With TheraCal PT, Biodentin, and MTA

NCT06880471 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2026-05-12

No results posted yet for this study

Summary

In this study, the researchers will evaluate the effect of three highly biocompatible materials-TheraCal PT (ThPT), Biodentin, and MTA-on postoperative pain in permanent teeth affected by deep caries and symptomatic irreversible pulpitis.

Participants:

The study will include 51 participants aged between 18 and 45 years who are systemically healthy.

Methodology:

Pulpotomy Procedure:

Pulpotomy will be performed on the lower first molar tooth of each participant. The teeth will be randomly divided into three groups, with 17 participants in each group. Coronal pulp tissue will be removed using a high-speed sterile diamond bur. Hemostasis will be achieved by applying gentle pressure with a cotton pellet soaked in 2.5% NaOCl, and this procedure may be repeated up to three times (totaling 6 minutes) if necessary.

Use of Biocompatible Materials:

After achieving hemostasis, one of the three biocompatible materials (TheraCal PT, Biodentin, or MTA) will be applied to the canal access. Participants will be prescribed NSAIDs.

Pain Assessment:

Preoperative Assessment : The pain intensity of participants will be recorded before treatment.

Postoperative Assessment : Participants will report their pain intensity at the 6th, 24th, 48th, and 72nd hours and on the 7th day using the Visual Analogue Scale (VAS). Participants will return with their VAS charts for evaluation at the end of one week.

Comparative Analysis:

The primary outcome will be a comparative evaluation of postoperative pain intensity values among the three different materials used in pulpotomy treatment. This study aims to provide valuable information on the effectiveness of various biocompatible materials in postoperative pain management and to contribute to improving clinical decision-making processes in endodontic treatments.

Conditions

  • Symptomatic Irreversible Pulpitis (SIP)

Interventions

BIOLOGICAL

TheraCal PT pulpotomy

After the coronal pulp tissue is removed using a high-speed sterile diamond bur and bleeding control is achieved, TheraCal PT material will be placed. According to the manufacturer's instructions, the irradiation time is 10 seconds. It is dual-cure. Its content is based on calcium silicate modified with resin.

BIOLOGICAL

MTA pulpotomy

After the coronal pulp tissue is removed using a high-speed sterile diamond bur and bleeding control is achieved, ProRoot MTA material will be placed. After waiting for 15 minutes for it to set, the restorative treatment will be performed. MTA consists of the main components: tricalcium silicate, dicalcium silicate, tricalcium aluminate, tricalcium oxide, silicate oxide, and calcium sulfate dihydrate.

BIOLOGICAL

Biodentine pulpotomy

After the coronal pulp tissue is removed using a high-speed sterile diamond bur and bleeding control is achieved, Biodentin material will be placed. After waiting for 12 minutes according to the manufacturer's instructions for it to set, the restorative treatment will be performed. Biodentin is a two-component material. The powder primarily consists of tricalcium silicate.

Sponsors & Collaborators

  • Cumhuriyet University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-12
Primary Completion
2025-10-01
Completion
2025-11-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06880471 on ClinicalTrials.gov