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

Sponsor

Mustafa Kemal University (Other)

Overall Status

Completed

CT.gov ID

NCT05923619

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

10.6

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Post-operative Pain Pulpitis - Irreversible	Procedure: Total pulpotomy Procedure: Root canal treatment	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

64 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

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

Actual Study Start Date :

Oct 13, 2022

Actual Primary Completion Date :

Apr 7, 2023

Actual Study Completion Date :

Apr 14, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Total pulpotomy The coronal pulp tissue was completely removed with a high-speed sterile carbide bur under abundant water coolant. A cotton pellet moistened with 2.5% sodium hypochlorite was used to achieve hemostasis. Following the achievement of hemostasis, an average of 3 mm thick MTA material (Angelus, Londrina, PR, Brazil) was used to cover the pulp chamber. In the same session, the pulp chamber was closed with approximately 2 mm thick flowable glass ionomer cement (Glass Liner, WP), and coronal restoration was completed with composite filling (Estelıte® Sıgma Quıck, Tokuyama).	Procedure: Total pulpotomy Total pulpotomy procedures explained in arm descriptions.
Active Comparator: Root canal treatment The working length was determined using a 15 K type file and apex locator (Morita Root ZX, Tokyo, Japan) and checked by radiography. The chemomechanical preparation was completed using the R25 (Resiproc, VDW, Munich, Germany) file in the mesial root canals and the R25, R40, and R50 files in the distal root canals, respectively, at the WL. During the chemomechanical preparation, the root canals were irrigated with 2.5% NaOCl after every three pecking motions; and total volume of NaOCl was 10 ml. In the final irrigation, the root canal was irrigated with 5 ml 17% Ethylene diamine tetraacetic acid (EDTA), for 1 minute, following with 2 ml distilled water. Following the retention of 5 ml of 2.5% NaOCl in the root canal for 1 minute, 5 ml of distilled used to neutralize the effect of NaOCl in the root canal.Tthe root canals were filled with the lateral condensation using epoxy-resin-based sealer (AH Plus, Dentsply DeTrey GmbH, Konstanz, Germany).	Procedure: Root canal treatment Root canal treatment procedures explained in arm descriptions.

Arm

Intervention/Treatment

Experimental: Total pulpotomy

The coronal pulp tissue was completely removed with a high-speed sterile carbide bur under abundant water coolant. A cotton pellet moistened with 2.5% sodium hypochlorite was used to achieve hemostasis. Following the achievement of hemostasis, an average of 3 mm thick MTA material (Angelus, Londrina, PR, Brazil) was used to cover the pulp chamber. In the same session, the pulp chamber was closed with approximately 2 mm thick flowable glass ionomer cement (Glass Liner, WP), and coronal restoration was completed with composite filling (Estelıte® Sıgma Quıck, Tokuyama).

Procedure: Total pulpotomy

Total pulpotomy procedures explained in arm descriptions.

Active Comparator: Root canal treatment

The working length was determined using a 15 K type file and apex locator (Morita Root ZX, Tokyo, Japan) and checked by radiography. The chemomechanical preparation was completed using the R25 (Resiproc, VDW, Munich, Germany) file in the mesial root canals and the R25, R40, and R50 files in the distal root canals, respectively, at the WL. During the chemomechanical preparation, the root canals were irrigated with 2.5% NaOCl after every three pecking motions; and total volume of NaOCl was 10 ml. In the final irrigation, the root canal was irrigated with 5 ml 17% Ethylene diamine tetraacetic acid (EDTA), for 1 minute, following with 2 ml distilled water. Following the retention of 5 ml of 2.5% NaOCl in the root canal for 1 minute, 5 ml of distilled used to neutralize the effect of NaOCl in the root canal.Tthe root canals were filled with the lateral condensation using epoxy-resin-based sealer (AH Plus, Dentsply DeTrey GmbH, Konstanz, Germany).

Procedure: Root canal treatment

Root canal treatment procedures explained in arm descriptions.

Outcome Measures

Primary Outcome Measures

post-operative pain [1 week]
Pre-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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Endodontics, Faculty of Dentistry, Hatay Mustafa Kemal University	Hatay	Antakya	Turkey	31000

Sponsors and Collaborators

Mustafa Kemal University

Investigators

Principal Investigator: Merve Sarı, DDS, Department of Endodontics, Faculty of Dentistry, Hatay Mustafa Kemal University
Study Director: Koray Yılmaz, Department of Endodontics, Faculty of Dentistry, Hatay Mustafa Kemal University