NCT06880471

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2024

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 12, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 21, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 17, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

March 17, 2025

Status Verified

March 1, 2025

Enrollment Period

10 months

First QC Date

January 21, 2025

Last Update Submit

March 11, 2025

Conditions

Symptomatic Irreversible Pulpitis (SIP)

Outcome Measures

Primary Outcomes (1)

  • Measurement of postoperative pain caused by TheraCal PT, Biodentin and MTA application at 6, 24, 48, 72 hours and 7 days

    In the study, TheraCal PT, Biodentin, and MTA materials will be applied to teeth with irreversible pulpitis. Preoperative pain values and postoperative pain values at 6, 24, 48, 72 hours and on the 7th day will be recorded. The preoperative and postoperative values of TheraCal PT, Biodentin, and MTA materials will be evaluated comparatively.

    6, 24, 48, 72 hours and 7 days

Other Outcomes (1)

  • Primary Outcome Measure Secondary Outcome Measure Other Pre-Specified Outcome

    The VAS questionnaire will assess postoperative pain at 6, 24, 48, 72 hours and 7 days.

Study Arms (3)

ProRoot MTA Application Procedure

ACTIVE COMPARATOR

The coronal pulp tissue of the tooth will be removed using a high-speed sterile diamond bur. Then, hemostasis will be achieved by applying gentle pressure with a cotton pellet soaked in 2.5% NaOCl for 2 minutes, and this procedure may be repeated up to 3 times (totaling 6 minutes) if necessary. After confirming bleeding control, ProRoot MTA material will be placed at the canal openings. Following a waiting period of 15 minutes, Resin Modified Glass Ionomer Cement (RMCIS) will be applied as the base material (Vitrebond, 3M; ESPE) in a thin layer. Finally, restorative treatment of the tooth will be performed to complete the procedure.

Biological: TheraCal PT pulpotomyBiological: Biodentine pulpotomy

Biodentine Application Procedure

ACTIVE COMPARATOR

After the coronal pulp tissue of the tooth is 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 for 2 minutes, and this may be repeated up to 3 times (for a total of 6 minutes) if necessary. Once bleeding control is established, Biodentin material will be placed at the canal openings. After a waiting period of 12 minutes according to the manufacturer's instructions, Resin Modified Glass Ionomer Cement (RMCIS) will be applied as a base material (Vitrebond, 3M; ESPE) in a thin layer. Finally, restorative treatment of the tooth will be performed to complete the procedure.

Biological: TheraCal PT pulpotomyBiological: MTA pulpotomy

TheraCal PT Application Procedure

ACTIVE COMPARATOR

After the coronal pulp tissue of the tooth is 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 for 2 minutes, and this may be repeated up to 3 times (totaling 6 minutes) if necessary. Once bleeding control is established, TheraCal PT material will be placed. According to the manufacturer's instructions, after a 10-second irradiation period, Resin Modified Glass Ionomer Cement (RMCIS) will be applied as a base material (Vitrebond, 3M; ESPE) in a thin layer. Finally, restorative treatment of the tooth will be performed to complete the procedure.

Biological: MTA pulpotomyBiological: Biodentine pulpotomy

Interventions

TheraCal PT pulpotomyBIOLOGICAL

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.

Biodentine Application ProcedureProRoot MTA Application Procedure
MTA pulpotomyBIOLOGICAL

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.

Biodentine Application ProcedureTheraCal PT Application Procedure
Biodentine pulpotomyBIOLOGICAL

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.

ProRoot MTA Application ProcedureTheraCal PT Application Procedure

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age range should be between 18 and 45,
  • Systemic disease should be absent,
  • Apical periodontitis findings may or may not be present,
  • Irreversible pulpitis symptoms should be present,
  • The apex of the tooth should be closed,
  • Pulp sensitivity tests (cold test and electric pulp test) should respond positively,
  • Periodontal pocket depth and mobility should be within normal limits,
  • Rubber dam isolation should be provided for the tooth to be treated,
  • Restorative treatment of the tooth should be performed,
  • The patient's mouth opening should be sufficient.

You may not qualify if:

  • The patient has any systemic disease (including conditions requiring prophylaxis),
  • The patient has mental or psychiatric disorders,
  • The patient has any allergic condition,
  • The patient has used painkillers in the last 12 hours before the procedure and antibiotics in the last week,
  • There is a loss of material in an amount that cannot be restoratively treated,
  • The presence of a fistula tract or abscess,
  • A negative response to pulp sensitivity tests (cold test and electric pulp test),
  • No bleeding in the pulp or failure to achieve hemostasis within 6 minutes after total pulpotomy,
  • The apex is open,
  • Advanced canal calcification is observed on periapical radiography,
  • The presence of internal or external root resorption.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Faculty of Dentistry, Sivas Cumhuriyet University

Sivas, 58000, Turkey (Türkiye)

RECRUITING

Sivas Republic University Faculty of Dentistry

Sivas, 58000, Turkey (Türkiye)

NOT YET RECRUITING

Central Study Contacts

Fatoş Albayrak assistant professor

CONTACT

+905532030079fatosdt3248@outlook.com

ESRA Kazan kazan

CONTACT

+905349551076dtesrakazan@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 21, 2025

First Posted

March 17, 2025

Study Start

December 12, 2024

Primary Completion

October 1, 2025

Study Completion

November 1, 2025

Last Updated

March 17, 2025

Record last verified: 2025-03

Locations

TU(2)