Evaluatıon of the Effect of Pulpotomy Treatments Wıth Dıfferent Bıomaterıals on Postoperatıve Paın In Permanent Molars

NCT06784622 | Not Yet Recruiting Phase 4

• 1 other identifier: 01
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to evaluate the results of partial and total pulpotomy with mineral trioxide aggregate (BIO MTA+) and bioceramic sealer (Well Root PT) in terms of pain and vitality in permanent molars with exposed pulp due to caries.

Conditions

Acute Pulpitis

Outcome Measures

Primary Outcomes (1)

• assessment of postoperative pain with questionnaires

  Visual Analogue Scala (VAS) will be used . 0: no pain 100: Worst pain

  12 month

Study Arms (2)

BİO MTA+ (CERKAMED, Poland) group

EXPERIMENTAL

Partial pulpotomy will be performed using bio mta+ (CERKAMED, Poland)

Drug: Treatment as usual

Well-Root PT (Vericom Co., Chuncheon, Kore) group

EXPERIMENTAL

Partial pulpotomy will be performed using Well-Root PT

Drug: Treatment as usual

Interventions

Treatment as usual DRUG

Well-Root PT is clinically used in many areas such as pulp capping, perforation and resorption repair, root tip filling and apexification. As Well-Root PT is available in pre-mixed capsule form, it can provide a consistent and adequate consistency and clinical convenience. Well-Root PT can be applied directly into the oral cavity by placing the capsule in a syringe. In addition, Well-Root PT has a shorter setting time than MTA.Despite these advantages, there is no study in the literature on the effect of Well-Root PT on postoperative pain and tooth vitality after pulpotomy in mature permanent molars

BİO MTA+ (CERKAMED, Poland) group; Well-Root PT (Vericom Co., Chuncheon, Kore) group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 18 years of age with no significant health problems.
• Restorable and periodontally healthy teeth.
• Teeth with complete root development.
• Teeth with cold sensitivity and positive response to electric pulp testing.
• Lower jaw first and second molars with deep/extremely deep caries detected on periapical radiographs.

You may not qualify if:

• Patients with systemic diseases or allergic reactions
• Teeth with open apex
• Carious teeth that do not respond to pulp sensitivity tests
• Teeth without signs of bleeding after opening the pulp chamber.
• Detection of periodontal pockets with a depth greater than 4 mm.
• Teeth with suspected cracks or crown fractures.
• Severely damaged teeth
• Teeth whose bleeding cannot be controlledTeeth with open apex

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Erciyes University Faculty of Dentistry

Kayseri, melikgazi, 38039, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Therapeutics

Central Study Contacts

fatma gürbüz r research assistant, master

CONTACT

+905533462383; fgurbuz181@gmail.com

yakup üstün, prof.

CONTACT

+0905066334177; yustun@erciyes.edu.tr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: research assistant

Study Record Dates

• First Submitted: January 14, 2025
• First Posted: January 20, 2025
• Study Start: February 1, 2025
• Primary Completion: June 1, 2025
• Study Completion: July 1, 2025
• Last Updated: January 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)