CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 75 enrolled
Drug / intervention
PULPOTOMY TREATMENTprocedure
Likely dose
Not stated in record
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Search/NCT06398327
NCT06398327N/ACompleted

Efficacy Of Proinflammatory Cytokines in the Clinical And Radiographic Outcomes of Different Primary Molar Pulpotomy Agents: A Comparative Study Featuring A Novel Biomarker For Pulpal Diagnosis

Ataturk University·interventional·Posted May 3, 2024·Updated May 3, 2024

In Brief

A clinical study evaluating PULPOTOMY TREATMENT for Pulp Disease, Dental. Completed, enrolled 75 participants across 1 site.

Detailed Summary

One of the main goals of pediatric dentistry is to preserve the functions and structures of primary teeth until the time of exfoliation. Especially carious lesions are the main factor in the early loss of primary teeth. Today, primary teeth can be kept in the mouth by applying different treatments depending on the degree of inflammation caused by carious lesions in the pulp tissue.Coronal pulpotomy application in asymptomatic primary teeth with deep carious lesions near the pulp is one of the most common methods to achieve the goal of retaining the tooth in place. The purpose of the pulpotomy technique is to remove the affected pulp tissue and maintain the normal function of the unaffected root pulp tissue until the tooth is naturally ready to exfoliate. Studies have shown that the degree of pulp inflammation and the materials used are effective in the success of this treatment. In studies evaluating pulpal inflammation, many biomarkers have been shown to play significant roles at different levels of inflammation. Recently, Presepsin has been studied as a biomarker for detecting bacterial infections. However, there is no study in the literature on the use of Presepsin as a biomarker in endodontic treatments. In our study, it is thought that Presepsin biomarker could be detected in cases of acute or chronic infection in pulp tissue and could be considered as one of the mediators of pulpal inflammation. Based on this, the aim of our study is to investigate whether the materials used in covering the pulp or the level of inflammation in the remaining pulp tissue is more important for the success of pulpotomy treatment. The inflammation level in the remaining pulp tissue will be measured using IL-6, IL-8, and Presepsin. Then, the one-year success of treatment in different groups where pulp tissue is randomly covered with MTA, NeoMTA, Biodentine, and Zinc oxide eugenol will be demonstrated. Thus, it will be evaluated whether materials previously found to be quite successful in other studies achieve success in pulps with high inflammation levels.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesTurkey (Türkiye)
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedMay 3, 2024
Enrollment StartNov 5, 2021
Primary CompletionNov 5, 2022
Study CompletionMay 17, 2023
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 2.2 years ago

Interventions

PULPOTOMY TREATMENTprocedure

During pulpotomy treatment, a bleeding sample was taken from the pulp and levels of presepsin, IL-6 and IL-8, which are important inflammation markers, were determined. During the treatment, MTA, Neo MTA, Biodentine and ZOE groups were randomly selected and the remaining pulp tissue was covered. After pulpotomy treatment, the teeth were followed for one year. Treatment success was evaluated according to the material used in teeth with high levels of inflammation at the beginning.