Pulp Inflammatory Markers and Outcome of Pulpotomy

Not Applicable

• Conditions: Pulpitis in Permanent Teeth; Dental Caries Extending to Pulp

• Registration Number: NCT06960603
• Lead Sponsor: King Abdullah University Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2024-10-07
• Study First Submitted: 2025-04-26
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-05
• Study First Posted: 2025-05-07
• Last Update Submitted: 2025-05-08
• Last Update Posted: 2025-05-13
• Primary Completion: 2025-12-31
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Pain relief	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 Outcome Measures

Name	Time	Method
Radiographic Findings	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

Trial Locations

Locations (1)

Jordan university of science and Technology; 🇯🇴 Irbid, Jordan