Clinical trial NCT06216951: Post-Operative Pain After Vital Pulpotomy in Molars With Symptomatic Pulpitis
Official title: Evaluation of Post-operative Pain After Vital Pulpotomy in Molars With Symptomatic Pulpitis: A Prospective Clinical Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulpitis
Post Operative Pain
Toothache
Keywords: toothache
pulpitis
pulpotomy
pain
postoperative
Lead sponsor: Uşak University
Sponsor class: OTHER
First posted: 2024-01-22
Enrollment: 114
Sex: ALL
Minimum age (years): 7
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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

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.

Eligibility criteria: 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, \&amp; 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.

Primary outcomes:
measure: Postoperative Pain Assesment
timeFrame: 1) on treatment day, before starting the treatment; 2)24 hours later; 3)72 hours later and 4) 1 week later
Secondary outcomes:
Other outcomes:
Locations:
city: Usak
country: Turkey
facility: Usak University School of Dentistry Department of Endodontics
Study officials:
affiliation: Usak University School of Dentistry
name: Berk Çelikkol, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lin LM, Ricucci D, Saoud TM, Sigurdsson A, Kahler B. Vital pulp therapy of mature permanent teeth with irreversible pulpitis from the perspective of pulp biology. Aust Endod J. 2020 Apr;46(1):154-166. doi: 10.1111/aej.12392. Epub 2019 Dec 21.
citation: Zanini M, Hennequin M, Cousson PY. A Review of Criteria for the Evaluation of Pulpotomy Outcomes in Mature Permanent Teeth. J Endod. 2016 Aug;42(8):1167-74. doi: 10.1016/j.joen.2016.05.008. Epub 2016 Jun 20.
citation: Witherspoon DE, Small JC, Harris GZ. Mineral trioxide aggregate pulpotomies: a case series outcomes assessment. J Am Dent Assoc. 2006 May;137(5):610-8. doi: 10.14219/jada.archive.2006.0256.