Clinical trial NCT06960603: Pulp Inflammatory Markers and Outcome of Pulpotomy
Official title: Effect of Pulp Inflammatory Mediators' Level on the Outcome of Full Pulpotomy in Teeth With Symptomatic Pulpitis
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Pulpitis in Permanent Teeth
Dental Caries Extending to Pulp
Keywords: Permanent teeth
Deep caries
Reversible pulpitis
Irrevrsible pulpitis
Pulpotomy
Inflammatory mediators
Lead sponsor: King Abdullah University Hospital
Sponsor class: OTHER
First posted: 2025-05-07
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Permanent teeth with deep caries reaching the dental pulp and requires full pulpotomy treatment
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain relief
timeFrame: 1 week, 6 months , 12 months
Secondary outcomes:
measure: Radiographic Findings
timeFrame: 6, 12, 24 months
Other outcomes:
Locations:
city: Irbid
country: Jordan
facility: Jordan university of science and Technology
Study officials:
affiliation: Jordan University of Science and Technology
name: Nessrin A Taha
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sharma R, Kumar V, Logani A, Chawla A, Mir RA, Sharma S, Kalaivani M. Association between concentration of active MMP-9 in pulpal blood and pulpotomy outcome in permanent mature teeth with irreversible pulpitis - a preliminary study. Int Endod J. 2021 Apr;54(4):479-489. doi: 10.1111/iej.13437. Epub 2020 Dec 13.
citation: Taha NA, About I, Sedgley CM et al. Conservative management of mature permanent teeth with carious pulp exposure. J Endod 2020; 46: S33-S4. Taha NA, Al-Khatib H. 4-Year Follow-up of Full Pulpotomy in Symptomatic Mature Permanent Teeth with Carious Pulp Exposure Using a Stainproof Calcium Silicate-based Material. J Endod 2022; 48: 87-95. Taha NA, Al-Rawash MH, IMRAN ZA. Outcome of full pulpotomy in mature permanent molars using 3 calcium silicate-based materials: A parallel, double blind, randomized controlled trial. Int Endod J 2022; 55:416-29.
citation: AAE Position Statement on Vital Pulp Therapy. J Endod. 2021 Sep;47(9):1340-1344. doi: 10.1016/j.joen.2021.07.015. Epub 2021 Aug 3. No abstract available.