Clinical trial NCT05923619: Evaluation of Post-operative Pain After Total Pulpotomy and Root Canal Treatment
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-operative Pain
Pulpitis - Irreversible
Keywords: irreversibl pulpitis
mineral trioxide aggregate
post-operative pain
total pulpotomy
Lead sponsor: Mustafa Kemal University
Sponsor class: OTHER
First posted: 2023-06-28
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: post-operative pain
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Hatay
country: Turkey
facility: Department of Endodontics, Faculty of Dentistry, Hatay Mustafa Kemal University
state: Antakya
Study officials:
affiliation: Department of Endodontics, Faculty of Dentistry, Hatay Mustafa Kemal University
name: Merve Sarı, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Endodontics, Faculty of Dentistry, Hatay Mustafa Kemal University
name: Koray Yılmaz
role: STUDY_DIRECTOR
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