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Evaluation of Post-operative Pain After Total Pulpotomy and Root Canal Treatment

Comparison of Post-operative Pain After Total Pulpotomy and Root Canal Treatment in Mature Molars According to New and Traditional Classification of Pulpitis: A Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05923619
Enrollment
64
Registered
2023-06-28
Start date
2023-01-13
Completion date
2023-10-13
Last updated
2024-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-operative Pain, Pulpitis - Irreversible

Keywords

irreversibl pulpitis, mineral trioxide aggregate, post-operative pain, total pulpotomy

Brief summary

The aim of this study was to compare post-operative pain following total pulpotomy (TP) and root canal treatment (RCT) in mature molar teeth with severe symptoms indicative of irreversible pulpitis. To compare the traditional pulpitis classification with the Wolters system in evaluating post-operative pain. Materials and Methods: Sixty-four mature mandibular molar with symptomatic vital pulps in patients aged 18-60 years were included and were classified according to the Wolters (moderate/severe pulpitis) and the traditional pulpitis classification (reversible/irreversible pulpitis). The teeth randomly divided into 2 groups. RCT was performed, using standardized protocols. TP was performed to the level of the canal orifices, and haemostasis was achieved with 2.5% NaOCl. 3 mm layer of MTA was placed as the pulpotomy agent. The treated teeth were restored with glass ionomer cement followed by composite. Pain was recorded 6, 12, 24, 48, 72 hours and 7 days after treatment. The data collected were statistically analyzed

Detailed description

The literature does not contain any studies comparing the effects of TP and RCT procedures on post-operative pain in mature molar teeth diagnosed with irreversible pulpitis and severe symptoms. Therefore, this study evaluated the effect of pre-operative and intra-operative variables and the treatment method on post-operative pain. Patient evaluation and treatment procedure As a result of clinical and radiographic examination, the teeth were classified both according to American Association of Endodontists (AAE) and as proposed by Wolters. The presence/absence of percussion was noted. Pre-operative pain levels were determined according to the Heft-Parker Visual Analog Scale (HP VAS), which consisted of a 10 mm long horizontal line where numerical values were divided into visual categories. Patients were instructed to score their pain with a value on the HP VAS. The presence or absence of pain was classified according to 4 categories: No pain (level 1, 0), Mild pain (level 2, 1-3 mm), Moderate pain (level 3, 4-6mm), Severe pain (level 4, 7-10 mm). After inferior alveolar nerve block anesthesia was performed with local anesthetic (adrenaline 4% Articaine, 1:100,000), the tooth was isolated with a rubber dam. The isolated area was cleaned using a cotton pellet wetted first with 3% hydrogen peroxide and then 2% chlorhexidine. The entire caries was removed non-selectively using a high-speed diamond bur under water coolant followed by a sterile round steel bur in a slow handpiece. After the pulp exposure was clinically confirmed, the patient was assigned to the TP or RCT group. Randomization was performed using online software with a four-block size block randomization technique to ensure even distribution between the groups (www.randomizer.org). The clinician could not be blinded due to the stages of treatment. Both patients were prescribed 400 mg of ibuprofen following treatment and asked to use it if necessary. They were informed to consult the clinic in case of severe post-operative pain that was not relieved by analgesics. All participants were administered a questionnaire form based on HP VAS, which could show their pain and analgesic intake after 6 hours, 12 hours, 24 hours, 48 hours, 72 hours, and seven days. Patients were asked to fill in the form. Patients were invited for clinical examination one week after treatment, and follow-up appointments were scheduled for three months, six months, and one year for patients who were observed to be asymptomatic.

Interventions

Total pulpotomy procedures explained in arm descriptions.

PROCEDURERoot canal treatment

Root canal treatment procedures explained in arm descriptions.

Sponsors

Mustafa Kemal University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

* Standard periodontal pocket depth and mobility, * Deep/extreme deep caries (periapical radiography), * Diagnosed with moderate and severe pulpitis according to the Wolters classification, * Had a positive response to the cold test, * Mandibular first and second molar teeth with completed root development.

Exclusion criteria

* Patients who had received antibiotic therapy in the last three months or used non-steroidal anti-inflammatory drugs within the last twelve hours, * Patients with diabetes or immunosuppressive disease or pregnancy, * Teeth that cannot be restored or require post-core, * Sinus tract or abscess, * Did not respond to pulp sensitivity test (cold test), * Teeth with no exposed pulp after non-selective caries removal.

Design outcomes

Primary

MeasureTime frameDescription
post-operative pain1 weekPre-operative and post-operative pain scores were determined according to the Heft-Parker Visual Analog Scale (HP VAS), which consisted of a 10 mm long horizontal line where numerical values were divided into visual categories. Patients were instructed to score their pain with a value on the HP VAS. The presence or absence of pain was classified according to 4 categories: No pain (level 1, 0), Mild pain (level 2, 1-3 mm), Moderate pain (level 3, 4-6mm), Severe pain (level 4, 7-10 mm).

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026