Completed

NCT Number: NCT06216951

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pulpitis Dental Pulp Diseases Facial Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Post Operative Pain Postoperative Complications Signs and Symptoms Stomatognathic Diseases Tooth Diseases Toothache

Age range

7 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Usak University School of Dentistry Department of Endodontics

Uşak, 64200, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vital Pulpotomy

Procedure

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.

Other names: vital pulp amputation

Primary outcomes

Postoperative Pain Assesment

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Uşak University

Other

Registry information

Official study title

Evaluation of Post-operative Pain After Vital Pulpotomy in Molars With Symptomatic Pulpitis: A Prospective Clinical Study

Acronym: POPAVPT

Important dates

Study start: 2021
Primary completion: 2024
Study completion: 2024
First posted: Jan 22, 2024
Registry last updated: Aug 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed