NCT06216951

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

Evaluation of Post-operative Pain After Vital Pulpotomy in Molars With Symptomatic Pulpitis: A Prospective Clinical Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 114 (actual)
• Sponsor: Uşak University · Academic / Other
• Sex: All
• Age: 7 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Pulpitis
• Post Operative Pain
• Toothache

Interventions

Type	Name	Description
PROCEDURE	Vital Pulpotomy	Vital pulpotomy involves the removal of the coronal pulp, while MTA is used to seal the root orifices. It is clear that vital pulp treatments for symptomatic pulpitis are a more reliable, cost-effective, and generally easier option than root canal treatment (RCT) once the mineral trioxide aggregate (MTA) is introduced in dentistry. In vital pulpotomy, as opposed to RCT, tooth healing and symptoms are diminished while the vitality of the tooth is maintained. Furthermore, vital pulpotomy is a significantly more practical and economical treatment alternative than RCT.

Timeline

• Start date: 2021-12-15
• Primary completion: 2024-03-15
• Completion: 2024-03-15
• First posted: 2024-01-22
• Last updated: 2024-08-27

Locations

1 site across 1 country: Turkey (Türkiye)