Pulpitis, Post Operative Pain, Toothache
Conditions
Keywords
toothache, pulpitis, pulpotomy, pain, postoperative
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.
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.
Interventions
PROCEDUREVital 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.
Sponsors
Uşak University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
7 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged between 7 and 70 years * The teeth with diagnosis of irreversible symptomatic pulpitis * Permanent first and second molars with vital pulp * PAI ≤ 2 with vital pulp. (Ørstavik D, Kerekes K, & Eriksen HM (1986) The periapical index: A scoring system for radiographic assessment of apical periodontitis Dent Traumatol 2(1) 20-34, https://doi.org/10.1111/j.1600-9657.1986.tb00119.x.)
Exclusion criteria
* Clinical or radiographic signs of a necrotic pulp * The presence of a sinus, buccal tenderness, pathological mobility or evidence of pathology on a periapical radiograph * Teeth with horizontal or vertical root fractures * Swelling, acute endodontic, or periodontal abscess * Insufficient tooth tissue for a restoration, teeth requiring a post * Unable to give informed consent * Contraindicated systemic disease * Allergies the local anesthesia * Antibiotics, biphosphonates, and corticosteroid intake during the 7 days before treatment. * Pregnancy or breastfeeding. * Patients who needed endodontic treatment on several teeth to avoid a potentially confused pain referral.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Assesment | 1) on treatment day, before starting the treatment; 2)24 hours later; 3)72 hours later and 4) 1 week later | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed