Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT06960603

Pulp Inflammatory Markers and Outcome of Pulpotomy

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jordan university of science and Technology

Irbid, 22110, Jordan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Full pulpotomy

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

King Abdullah University Hospital

Other

Registry information

Official study title

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

Acronym: pulpitis

Important dates

Study start
2024
Primary completion
2025
Study completion
2027
First posted
May 7, 2025
Registry last updated
May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.