Pulp capDirect Pulp Capping vs. Partial Pulpotomy for Carious Pulp Exposure in Mature Teeth
The study compares the effectiveness of direct pulp capping and partial pulpotomy in resolving symptoms in adults with carious pulp exposure in mature teeth.
Direct pulp capping and partial pulpotomy
Dental Pulp Diseases+5
+ Stomatognathic Diseases
+ Neurologic Manifestations
Treatment Study
Summary
Study start date: March 25, 2023
Actual date on which the first participant was enrolled.This clinical trial is focused on finding the best way to treat teeth with deep cavities that expose the pulp, which is the innermost part of a tooth containing nerves and blood vessels. The study aims to compare two treatment methods: direct pulp capping and partial pulpotomy, using a material called Biodentine. It targets mature teeth with symptoms that suggest the pulp inflammation can be reversed, a condition known as reversible pulpitis. The research is significant because it seeks to improve the success rates of these treatments, which can help preserve natural teeth and reduce the need for more invasive procedures like root canals. Participants in the study will have one of two procedures: direct pulp capping, where a protective layer is placed over the exposed pulp, or partial pulpotomy, which involves removing a small portion of the pulp before sealing it. The study will monitor the pain levels of participants at 48 hours and 7 days after the procedure using a pain scale. Additionally, blood from the pulp will be tested for certain substances (MMP9 levels) that might affect the treatment's success. Patients' treated teeth will be checked both clinically and with X-rays at 6 and 12 months, and then annually, to determine the long-term effectiveness of the treatments.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.120 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 12 to 60 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Non -contributory medical history (ASA 1) * Molar tooth with extremely deep caries extending\>2/3 of dentin or exposing the pulp on the periapical radiograph * The tooth should give positive response to cold testing * Clinical diagnosis of reversible pulpitis with mild to moderate symptoms * The tooth is restorable, probing pocket depth and mobility are within normal limits * No signs of pulpal necrosis including sinus tract or swelling * No radiographic evidence of periapical changes indicative of apical periodontitis Exclusion Criteria: Immature teeth * Nonvital teeth * Irreversible pulpitis and periapical periodontitis, i.e spontaneous and lingering pain. * Inability to achieve hemostasis after 6 minutes of application of 5% NaOCl moist pellet * No pulp exposure after nonselective caries removal
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Faculty of Dentistry, Jordan University of Science and Technology
Irbid, JordanOpen Faculty of Dentistry, Jordan University of Science and Technology in Google Maps