Effect of Different Root Canal Sealers on Postoperative Pain

NCT06726837 | Not Yet Recruiting

• 2 other identifiers: DUFD-END-MYO-01DİŞ.24.013
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized clinical study aims to compare postoperative pain in patients after root canal treatments using different root canal filling materials.The root canal pastes that will be tested for postoperative pain in this study have been used worldwide for many years. Seventy-two patients with single-rooted teeth without pain symptoms but diagnosed with pulpitis and without any previous fillings or prostheses will be randomly divided into three groups according to the root canal sealers. Then the teeth in these groups will be treated with three different root canal sealers. Endodontic treatment will be performed in a single session, following standardized preparation and irrigation protocols, using the warm vertical condensation technique on all teeth. Patients will be given a Visual Analog Pain Assessment Scale and asked to mark their pain levels between 0 and 10 at 6, 24, 48, 72 hours, and 7 days after root canal treatment. Patients will be called for a check-up at the end of the 7th day, and VAS questionnaires will be collected. The investigators will be made to determine which root canal sealer causes the least pain. The null hypothesis of this study was that there would be no difference in post-procedure pain between the groups.

Conditions

Postoperative Dental Pain; Root Canal Obturation; Warm Vertical Compaction; Root Canal Sealers; Visual Analog Scale

Keywords

Postoperative pain; AH Plus; Bio-C Sealer; TotalFill BC Sealer; visual analog scale

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale

  It is a system in which the patient marks the level of pain on a straight line divided from 0 to 10.

  6th hour, 24th hour, 48th hour, 72nd hour, 7th day

Study Arms (3)

Group 1: AH Plus Root Canal Sealer

ACTIVE COMPARATOR

Patients will be informed and have an informed consent form signed. Infiltrative anesthesia (4% articaine hydrochloride containing 1:100,000 adrenaline) will be applied. The relevant tooth will be isolated, and the access cavity will be prepared. The canal length will be determined, and canals will be prepared with Reciproc R25 files. 15 ml of 2.5% sodium hypochlorite (NaOCl) will be used. In the final irrigation, 5 ml of 17% EDTA, 5 ml of 2.5% NaOCl, and 2 ml of distilled water will be used and activated with a sonic activation device. All canals will be filled using the warm vertical condensation technique and AH Plus root canal sealer (n=24). All treatments will be completed in a single session. Patients will be given a visual analog scale (VAS) form and asked to mark their pain levels between 0 and 10 at 6, 24, 48, 72 hours, and 7 days after treatment. At the end of the 7th day, patients will be called for a check-up, and VAS questionnaires will be collected.

Other: Postoperative pain - 6th hour; Other: Postoperative pain - 24th hour; Other: Postoperative pain - 48th hour; Other: Postoperative pain - 72nd hour; Other: Postoperative pain - 7 day

Group 2: TotalFill BC Sealer

ACTIVE COMPARATOR

All anesthesia, isolation, root canal preparation procedure, and filling technique are the same as in group 1. However, TotalFill BC root canal sealer will be used in this group instead of Ah Plus, which was used in group 1.

Other: Postoperative pain - 6th hour; Other: Postoperative pain - 24th hour; Other: Postoperative pain - 48th hour; Other: Postoperative pain - 72nd hour; Other: Postoperative pain - 7 day

Group 3: Bio-C Root Canal Sealer

ACTIVE COMPARATOR

All anesthesia, isolation, root canal preparation procedure, and filling technique are the same as in group 1. However, Bio-C root canal sealer will be used in this group instead of Ah Plus, which was used in group 1.

Other: Postoperative pain - 6th hour; Other: Postoperative pain - 24th hour; Other: Postoperative pain - 48th hour; Other: Postoperative pain - 72nd hour; Other: Postoperative pain - 7 day

Interventions

Postoperative pain - 6th hour OTHER

Patients will be given the VAS Pain Assessment Scale and asked to mark their pain levels between 0 and 10 at 6th hour.

Group 1: AH Plus Root Canal Sealer; Group 2: TotalFill BC Sealer; Group 3: Bio-C Root Canal Sealer

Postoperative pain - 24th hour OTHER

Patients will be given the VAS Pain Assessment Scale and asked to mark their pain levels between 0 and 10 at 24th hour.

Group 1: AH Plus Root Canal Sealer; Group 2: TotalFill BC Sealer; Group 3: Bio-C Root Canal Sealer

Postoperative pain - 48th hour OTHER

Patients will be given the VAS Pain Assessment Scale and asked to mark their pain levels between 0 and 10 at 48th hour.

Group 1: AH Plus Root Canal Sealer; Group 2: TotalFill BC Sealer; Group 3: Bio-C Root Canal Sealer

Postoperative pain - 72nd hour OTHER

Patients will be given the VAS Pain Assessment Scale and asked to mark their pain levels between 0 and 10 at 72nd hour.

Group 1: AH Plus Root Canal Sealer; Group 2: TotalFill BC Sealer; Group 3: Bio-C Root Canal Sealer

Postoperative pain - 7 day OTHER

Patients will be given the VAS Pain Assessment Scale and asked to mark their pain levels between 0 and 10 at 7 day.

Group 1: AH Plus Root Canal Sealer; Group 2: TotalFill BC Sealer; Group 3: Bio-C Root Canal Sealer

Eligibility Criteria

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

You may qualify if:

• Patients aged 18-65 years
• Patients who agreed to participate in this study
• Patients with single-canal, single-rooted teeth diagnosed with asymptomatic irreversible pulpitis due to trauma or deep carious lesions and patients with single-canal, single-rooted teeth referred for endodontic treatment for prosthetic reasons
• Patients with asymptomatic teeth
• Patients who have not used any analgesic, anti-inflammatory, or antibiotic drugs in the last 7 days
• Patients with good oral hygiene
• Patients with a sustained positive response to cold test and electric pulp test
• Patients with healthy periapical tissues (to be confirmed by periapical radiography)

You may not qualify if:

• Patients who refused to participate in this study
• Patients with medical problems (patients with immunosuppressive/systemic diseases, patients on medication)
• Patients with negative responses to thermal and electrical pulp tests
• Patients with advanced periodontal disease (probing depth \>4 mm)
• Patients with preoperative percussion and palpation of the involved tooth
• Open apex, presence of calcification, presence of resorption
• Patients requiring endodontic treatment of more than one tooth
• Patients with allergic sensitivity to materials and agents to be used during root canal treatment
• Patients with allergic sensitivity to local anesthetics
• Patients with systemic or allergic sensitivity to NSAIDs
• Pregnant and lactating patients
• Teeth that cannot be restored due to excessive material loss in the coronal structure
• Overenstrumentation (extension of gutta-percha or root canal sealer beyond the radiographic apex) or short filling (more than 2 mm below the radiographic apex )
• Patients who develop acute exacerbations after the procedure

Sponsors & Collaborators

• Dicle University: lead

Study Sites (1)

Dicle University, Faculty of Dentistry, Department of Endodontics

Diyarbakır, 21010, Turkey (Türkiye)

Location

Related Publications (2)

• Cosar M, Kandemir Demirci G, Caliskan MK. The effect of two different root canal sealers on treatment outcome and post-obturation pain in single-visit root canal treatment: A prospective randomized clinical trial. Int Endod J. 2023 Mar;56(3):318-330. doi: 10.1111/iej.13870. Epub 2022 Nov 22.

  PMID: 36385378 RESULT

• Ferreira NS, Gollo EKF, Boscato N, Arias A, Silva EJNLD. Postoperative pain after root canal filling with different endodontic sealers: a randomized clinical trial. Braz Oral Res. 2020;34:e069. doi: 10.1590/1807-3107bor-2020.vol34.0069. Epub 2020 Jul 15.

  PMID: 32696911 RESULT

Related Links

• Root canal obturation

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Merve Yeniceri Ozata, Assoc Prof

  Dicle University, Faculty of Dentistry, Department of Endodontics

  STUDY DIRECTOR

Central Study Contacts

Merve Yeniceri Ozata, Assoc Prof

CONTACT

+905066899344; merve.yeniceri@dicle.edu.tr

Merve Defiset, Res Assist

CONTACT

+905052373980; defisetmerve28@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The participants will blinded to the group to which they will assigned, but the operator will aware of it. Outcome assessments will be performed by a investigator who was blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 6, 2024
• First Posted: December 10, 2024
• Study Start: January 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: November 1, 2025
• Last Updated: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)