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

NCT06216951 | Completed DMC

• 1 other identifier: 180-180-13
• Study Type: observational
• Target: 114
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulpitis; Post Operative Pain; Toothache

Keywords

toothache; pulpitis; pulpotomy; pain; postoperative

Outcome Measures

Primary Outcomes (1)

• 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.

  1) on treatment day, before starting the treatment; 2)24 hours later; 3)72 hours later and 4) 1 week later

Study Arms (1)

Patients with symptomatic pulpitis

vital permanent molars with symptomatic pulpitis in patients aged between 7-70

Procedure: Vital Pulpotomy

Interventions

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.

Also known as: vital pulp amputation

Patients with symptomatic pulpitis

Eligibility Criteria

• Age: 7 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Uşak University: lead

Study Sites (1)

Usak University School of Dentistry Department of Endodontics

Uşak, 64200, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 31865629 BACKGROUND

• 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.

  PMID: 27339631 BACKGROUND

• 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.

  PMID: 16739540 BACKGROUND

Related Links

• American Association of Endodontics, Clinical Guideline on Vital Pulp Therapy

MeSH Terms

Conditions

Pulpitis; Pain, Postoperative; Toothache; Pain

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Facial Pain

Study Officials

• Berk Çelikkol, Dr

  Usak University School of Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: January 22, 2024
• Study Start: December 15, 2021
• Primary Completion: March 15, 2024
• Study Completion: March 15, 2024
• Last Updated: August 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)