Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-25 @ 9:37 PM
Study NCT ID:
NCT06216951
Status:
COMPLETED
Last Update Posted:
2024-08-27
First Post:
2024-01-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Post-Operative Pain After Vital Pulpotomy in Molars With Symptomatic Pulpitis
Sponsor:
Uşak University
Organization:
Study Overview
Official Title:
Evaluation of Post-operative Pain After Vital Pulpotomy in Molars With Symptomatic Pulpitis: A Prospective Clinical Study
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
POPAVPT
Brief 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.
* 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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: