An observational study in Pulpitis, Post Operative Pain and Toothache, sponsored by Uşak University. Completed at 1 site in Turkey. Open to participants aged 7 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-08-27.
Sponsored by Uşak University · Observational
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:
Participants will:
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.
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.
302 studies on the registry are indexed under Pulpitis; 67 are open to participants now.
This study's enrollment of 114 is above the median of 90 across 21 observational studies indexed under Pulpitis.
Browse Pulpitis studies →Uşak University is the lead sponsor of 78 studies on the registry; 11 are open to participants now.
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Patients aged between 7 and 70 with a noncontributory medical history presented for endodontic treatment at the Department of Endodontics and Department of Pediatric Dentistry, Faculty of Dentistry, Usak University, Turkey
Exclusion Criteria:
vital permanent molars with symptomatic pulpitis in patients aged between 7-70
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.
Also known as: vital pulp amputation
Postoperative Pain Assesment
Pain scores before and after treatment will be assessed using a modified Wong-Baker pain rating scale. The patients and parents will be given with comprehensive information and instructed to indicate their level of pain using a pain rating scale (0 = no pain, 1 = slight pain, 2 = moderate pain, 3 = severe pain) before treatment, at 24 hours, and 72 hours after the procedure. Additionally, they will be asked about the use of painkillers.
Time frame: 1) on treatment day, before starting the treatment; 2)24 hours later; 3)72 hours later and 4) 1 week later
Plan to share: No — due to possible plagiarism issues, we are kindly requesting that the study descriptions be shared only after journal publication
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Uşak University