Pulp Inflammatory Markers and Outcome of Pulpotomy (pulpitis)

May 8, 2025 updated by: Nessrin Taha, King Abdullah University Hospital

Effect of Pulp Inflammatory Mediators' Level on the Outcome of Full Pulpotomy in Teeth With Symptomatic Pulpitis

This is a prospective clinical study that aims to investigate the level of inflammatory mediators in the inflamed dental pulp and its potential relationship to the outcome of full pulpotomy in mature permanent teeth with carious pulp exposure.

Pulp blood samples from the teeth will be collected during treatment, MMP9 levels will be recorded using Elisa kits. The teeth will be restored and followed up at 1 week, 6 months, 1, and 2 years. The teeth will be assesses both clinically and radiographically. The procedure will be success if the tooth is asymptomatic clinically and with normal periapical findings. The relationship between MMP9 level and success of treatment will be investigated.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Dental caries is one of the most common chronic diseases of adults and children. If left untreated, the disease can have a wide range of dental, medical, social, and quality of life consequences, such as pain, infection, early tooth loss, and loss of self-confidence.

Full pulpotomy is a vital pulp therapy procedure that involves the removal of the coronal pulp to the levels of canal orifices followed by achieving hemostasis and placement of a biocompatible capping material. Full pulpotomy has been proved to be a promising alternative treatment option to the conventional root canal treatment in cariously exposed molars with either diagnosis of reversible or irreversible pulpitis.

Clinically, diagnosing the actual histopathological status of the inflamed pulp is challenging and is an empirical guess based on the results of sensibility testing and patients' symptoms. In recent years there has been an attempt to investigate the level of inflammatory mediators in the pulp, with an attempt to develop a chairside diagnosis tool that will help better in diagnosing the state of the pulp; and therefore, predict the outcome of treatment procedures.

In recent years matrix metalloproteinases (MMPs) have been increasingly studied for their role in the diagnosis of dental inflammatory processes. Several studies evaluated the correlation between inflammation of the dental pulp and the levels of MMPs (MMP-1, -2, -3,-8 and -9), in addition to other molecular markers like interluekins and prostaglandins.

However, the use of concentrations of MMPs in the pulpal blood as a marker to differentiate between reversible and irreversible pulpitis has not been thoroughly investigated yet.

The aim of the study is to investigate the inflammatory mediators' level in inflamed pulps and to assess its relation to the outcome of full pulpotomy in carious teeth with symptomatic pulpitis.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Jordan
      • Irbid, Jordan, 22110
        • Jordan University of Science and Technology

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

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Non -contributory medical history (ASA 1)

    • Molar tooth with deep caries extending>= 2/3 of dentine or exposing the pulp on the radiograph
    • The tooth should give positive response to cold sensibility testing
    • Clinical diagnosis of either reversible or irreversible pulpitis based on the symptoms and results of cold testing.
    • The tooth is restorable, probing pocket depth and mobility are within normal limits

Exclusion Criteria:

  • Non-restorable tooth.

    • Signs of pulpal necrosis including sinus tract or swelling.
    • No enough bleeding after the pulpotomy procedure.
    • Inability to achieve hemostasis within 10 min after the pulpotomy.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Full pulpotomy using calcium silicate based material for teeth with carious pulp exposure

The tooth with carious pulp exposure will be treated with full pulpotomy, Blood samples will be collected from the tooth for investigation of inflammatory mediator level. Calcium silicate based material will be placed over the pulp and the tooth will restored with resin composite.

Patients symptoms will be monitored at 1 week postoperatively, the patient will score their pain levels on a scale from 0-10.

The patients will be recalled at 6 and 12 months post procedure. The tooth will be examined for symptoms of pain, and radiographs will be taken. based on the findings it will be scored as success or failure of the pro cedure.

this result will be corelated with the level of measure inflammatory mediators that were taken during the procedure.
Other: Full pulpotomy
First: Cutting the coronal pulp tissue to the level of the root canal orifices. Second: Followed by taking samples of the pulpal blood Third: Placement of calcium silicate material capping over the pulp
Other Names:
  • Cervical pulpotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain relief
Time Frame: 1 week, 6 months , 12 months

Pain levels after the procedure will be assessed on a scale from 0-10, at 1 week, 6 months an 12 months postoperatively.

The procedure will be considered success if the tooth is symptom free and pain levels range form 0-3.

It will be considered as a failure If pain levels are >0-3
1 week, 6 months , 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic Findings
Time Frame: 6, 12, 24 months

A periapical x-ray will be taken for the tooth immediately after treatment and at 6 12, and 24 months follow up.

For success the tooth should be free of root resorption and free of bone resorption around the root
6, 12, 24 months

Collaborators and Investigators

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

Sponsor

King Abdullah University Hospital

Investigators

  • Principal Investigator: Nessrin A Taha, Jordan University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

October 7, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

April 26, 2025

First Submitted That Met QC Criteria

May 5, 2025

First Posted (Actual)

May 7, 2025

Study Record Updates

Last Update Posted (Actual)

May 13, 2025

Last Update Submitted That Met QC Criteria

May 8, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 462/2024 (Other Grant/Funding Number: Jordan university of Science and Technology)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The data will be available upon reasonable request after officila publication and termination of recruitment

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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