Post-Operative Pain After Vital Pulpotomy in Molars With Symptomatic

Status Recruiting

Clinical Trial Summary

The goal of this clinical trial is to investigate post-operative pain (PEP) in teeth with symptomatic pulpitis following Vital Pulpotomy Treatments (VPT) with Calcium Silicate Cement (CSC). The main questions it aims to answer are: - Is the post-operative pain one week after VPT significantly lower than pre-operative pain in permanent molars with symptomatic pulpitis? - How does post-operative pain in these teeth correlate with patient-related factors, such as age, gender, and painkiller intake? Participants will: - Undergo Vital Pulpotomy Treatment with Calcium Silicate Cement (MTA) - Provide pain level assessments before VPT, immediately post-treatment, and at 24, 72 hours, and 1 week after treatment. If there is a comparison group: Researchers will compare the post-operative pain levels in teeth with symptomatic pulpitis undergoing VPT to assess its effectiveness in reducing pain compared to a control group not undergoing the treatment.

Clinical Trial Description

Informed Consent: Volunteers or parents will receive detailed information about protocols, risks, and benefits. Informed consent was obtained in writing after providing subject information, and participants could withdraw voluntarily at any time. Sample Size Calculation: Sample size calculation, utilizing G. Power-3.1.9.2, aimed at relationship analyses with a 95% confidence level, α=0.05, effect size of 0.30, and theoretical power of 0.80, resulting in a minimum sample size of 108. Treatment Procedure: Vital pulpotomy, administered by experienced professionals, involved local anesthesia, rubber dam isolation, caries removal, pulp amputation, hemostasis, application of ProRoot MTA and glass ionomer, and permanent restoration. Pain scores, assessed using the modified Wong-Baker scale, were recorded pre-treatment, at 24 and 72 hours post-procedure, along with inquiries about painkiller usage. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06216951
Study type	Observational
Source	Usak University
Contact	Berk Çelikkol, Dr
Phone	+90 5414410422
Email	berk.celikkol@usak.edu.tr
Status	Recruiting
Phase
Start date	December 15, 2021
Completion date	March 15, 2024

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Post-Operative Pain After Vital Pulpotomy in Molars With Symptomatic Pulpitis — POPAVPT

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms