Pulp Inflammatory Markers and Outcome of Pulpotomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Full pulpotomy.
- Who it may be relevant to
- Registry conditions: Pulpitis in Permanent Teeth, Dental Caries Extending to Pulp. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Jordan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effect of Pulp Inflammatory Mediators' Level on the Outcome of Full Pulpotomy in Teeth With Symptomatic Pulpitis
Overview
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.
Interventions
- 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
Primary outcome measures
- Pain relief [Time frame: 1 week, 6 months , 12 months]
Secondary outcome measures (1)
- Radiographic Findings [Time frame: 6, 12, 24 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Jordan · 1 center
- Jordan university of science and Technology — Irbid
Publications
- 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. PMID 33128238
- 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
- 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. PMID 34352305
Identifiers
NCT: NCT06960603 · 462/2024 · 462/2024