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

Uşak University

Status

Completed

Conditions

Pulpitis

Toothache

Post Operative Pain

Treatments

Procedure: Vital Pulpotomy

Study type

Observational

Funder types

Other

Identifiers

NCT06216951

180-180-13

Details and patient eligibility

About

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.

Full 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.

Enrollment

114 patients

Sex

All

Ages

7 to 70 years old

Volunteers

No Healthy Volunteers

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.