Pulp Inflammatory Markers and Outcome of Pulpotomy (pulpitis)

King Abdullah University Hospital

Status: Invitation-only

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

Treatments: Other: Full pulpotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT06960603

462/2024 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Full pulpotomy using calcium silicate based material for teeth with carious pulp exposure

Experimental group

Description:

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.

Treatment:

Other: Full pulpotomy