RecruitingNot ApplicableNCT06880471

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

Effects of TheraCal PT, Biodentin, and MTA on Postoperative Pain After Full Pulpotomy in Permanent Teeth With Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial


Sponsor

Cumhuriyet University

Enrollment

51 participants

Start Date

Dec 12, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 45 Years

Inclusion Criteria10

  • 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.

Exclusion Criteria11

  • 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.

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Interventions

BIOLOGICALTheraCal 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.

BIOLOGICALMTA 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.

BIOLOGICALBiodentine 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.


Locations(2)

Faculty of Dentistry, Sivas Cumhuriyet University

Sivas, Turkey (Türkiye)

Sivas Republic University Faculty of Dentistry

Sivas, Turkey (Türkiye)

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NCT06880471


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