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

January 17, 2025 updated by: Fatma GURBUZ, TC Erciyes University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Dental caries, an infectious disease, is the most common cause of pulp inflammation. However, the dentin-pulp complex has several physiological defence mechanisms against caries. Preserving pulp viability is the primary goal of biologically based, minimally invasive treatments. Therefore, vital pulp treatments such as partial and total pulpotomies have become increasingly common. Vital pulp therapy is a series of conservative procedures that rely on the natural repair mechanisms of the dentin-pulp complex. This treatment is based on the placement of an appropriate medicamentous and sealed coronal restoration to create a biologically suitable environment for the pulp tissue to heal and protect against bacterial contamination. Root canal treatment is also commonly performed on teeth with deep caries. However, despite the high success rate of 89%, problems such as transpotation, apical zipper formation, instrument breakage during mechanical preparation, failure to reach all canals and inadequate or excessive root filling can lead to treatment failure. Unlike root canal treatment, which involves the removal of all pulp tissue, vital pulp treatment preserves the immune defence and regenerative potential of the pulp and allows root development to continue in immature teeth. Many studies show that the carious pulp of mature teeth is capable of regeneration and that vital pulp therapy is successful in symptomatic and permanent teeth . In recent years, calcium silicate-based cements (MTA, biodentin and bioceramic cements) have become the standard biomaterials for vital pulp treatment due to their biocompatibility and bioactivity . In vivo studies have shown predictable histological results in pulp healing with pulpotomy treatments using MTA . However, as MTA is manufactured in powder/liquid form, it requires a mixing procedure prior to application. As it is difficult to achieve the appropriate consistency of the powder/liquid ratio during the mixing process , changes in the mechanical or chemical properties of the materials may occur. A previous in vitro study found that changes in the powder/liquid ratio affected the radiopacity, setting time, solubility and calcium ion release of MTA. Well-Root PT (Vericom Co., Chuncheon, Korea), a premixed cement, has recently been introduced to the market. 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 (approximately 5 minutes for initial setting and 45 minutes for final setting) . 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. Therefore, the aim of this study was to evaluate the effect of Well-Root PT on postoperative pain and tooth vitality in vivo in comparison with MTA (BIO MTA+).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
54

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: fatma gürbüz r research assistant, master
  • Phone Number: +905533462383 +905533462383
  • Email: fgurbuz181@gmail.com

Study Contact Backup

Study Locations

  • Turkey
    • Melikgazi
      • Kayseri, Melikgazi, Turkey, 38039
        • Erciyes University Faculty of Dentistry
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: BİO MTA+ (CERKAMED, Poland) group
Partial pulpotomy will be performed using bio mta+ (CERKAMED, Poland)
Drug: Treatment as usual
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
Experimental: Well-Root PT (Vericom Co., Chuncheon, Kore) group
Partial pulpotomy will be performed using Well-Root PT
Drug: Treatment as usual
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
assessment of postoperative pain with questionnaires
Time Frame: 12 month
Visual Analogue Scala (VAS) will be used . 0: no pain 100: Worst pain
12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
TC Erciyes University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 14, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 17, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 01 (Leona M. and Harry B. Helmsley Charitable Trust)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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