Effect of Different Root Canal Sealers on Postoperative Pain

NCT06726837 | Completed

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

Brief Summary

This randomized clinical trial aimed to evaluate postoperative pain following the use of bioceramic and epoxy resin-based root canal sealers in combination with the continuous wave of condensation technique (CWCT), addressing a clinically relevant gap in the literature. Seventy-two patients with single-rooted teeth diagnosed with asymptomatic irreversible pulpitis and presenting without preoperative pain were randomly assigned to three groups according to the root canal sealer used. The teeth were treated using AH Plus, TotalFill BC, or Bio-C Sealer. All endodontic procedures, including post-endodontic restorations, were completed in a single visit using the continuous wave of condensation technique (CWCT), following standardized preparation and irrigation protocols. Patients were provided with a Visual Analog Scale (VAS) form and were instructed to record their pain intensity on a scale from 0 to 10 at 6, 24, 48, and 72 hours, and 7 days after root canal treatment. Patients were recalled on day 7, and the completed VAS forms were collected. The null hypothesis was that the type of root canal sealer would have no statistically significant effect on postoperative pain levels. The alternative hypothesis was that, regardless of sealer type, the incidence and severity of postoperative pain would be significantly higher within the first 24 hours following treatment compared with the other assessment time points.

Conditions

Postoperative Dental Pain; Root Canal Sealers; Asymptomatic Irreversible Pulpitis

Keywords

Postoperative pain; Root canal sealers; Asymptomatic irreversible pulpitis; Visual analog scale; Warm obturation

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

Secondary Outcomes (1)

• Postoperative pain incidence

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

Other Outcomes (1)

• Analgesic intake

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

Study Arms (3)

Group 1: AH Plus Root Canal Sealer (Dentsply DeTrey, Konstanz, Germany)

ACTIVE COMPARATOR

Participants with asymptomatic irreversible pulpitis in single-rooted teeth received root canal treatment under local anesthesia and rubber dam isolation. Working length was determined using an electronic apex locator and confirmed radiographically. Root canals were prepared using the T-Endo MUST reciprocating file system and irrigated with 2.5% sodium hypochlorite, followed by a final irrigation protocol consisting of 17% EDTA, 2.5% sodium hypochlorite, and distilled water with sonic activation. AH Plus sealer was applied according to the manufacturer's instructions, and canals were obturated using the continuous wave of condensation technique (CWCT). All treatments, including post-endodontic restorations, were completed in a single visit. Postoperative pain and analgesic intake were recorded using a visual analog scale (VAS) at 6, 24, 48, and 72 hours and at 7 days.

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 (FKG Dentaire SA, La Chaux-de-Fonds, Switzerland)

ACTIVE COMPARATOR

All clinical procedures were identical to those performed in Group 1. The only difference was the use of TotalFill BC Sealer instead of AH Plus. The premixed sealer was injected into the coronal third of the canal according to the manufacturer's instructions.

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 Sealer (Angelus, Londrina, Paraná, Brazil)

ACTIVE COMPARATOR

All clinical procedures were identical to those performed in Group 1. The only difference was the use of Bio-C Sealer instead of AH Plus. The premixed sealer was injected into the coronal third of the canal according to the manufacturer's instructions.

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 (Dentsply DeTrey, Konstanz, Germany); Group 2: TotalFill BC Sealer (FKG Dentaire SA, La Chaux-de-Fonds, Switzerland); Group 3: Bio-C Sealer (Angelus, Londrina, Paraná, Brazil)

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 (Dentsply DeTrey, Konstanz, Germany); Group 2: TotalFill BC Sealer (FKG Dentaire SA, La Chaux-de-Fonds, Switzerland); Group 3: Bio-C Sealer (Angelus, Londrina, Paraná, Brazil)

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 (Dentsply DeTrey, Konstanz, Germany); Group 2: TotalFill BC Sealer (FKG Dentaire SA, La Chaux-de-Fonds, Switzerland); Group 3: Bio-C Sealer (Angelus, Londrina, Paraná, Brazil)

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 (Dentsply DeTrey, Konstanz, Germany); Group 2: TotalFill BC Sealer (FKG Dentaire SA, La Chaux-de-Fonds, Switzerland); Group 3: Bio-C Sealer (Angelus, Londrina, Paraná, Brazil)

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 (Dentsply DeTrey, Konstanz, Germany); Group 2: TotalFill BC Sealer (FKG Dentaire SA, La Chaux-de-Fonds, Switzerland); Group 3: Bio-C Sealer (Angelus, Londrina, Paraná, Brazil)

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-rooted, single-canal maxillary or mandibular teeth diagnosed with asymptomatic irreversible pulpitis
• 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

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants were blinded to group allocation, whereas the operator was aware of the assigned sealer. Outcome assessments were performed by an investigator blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Seventy-two participants were randomly allocated to three parallel groups according to the root canal sealer used (AH Plus, TotalFill BC Sealer, or Bio-C Sealer). Postoperative pain outcomes were compared among the groups.

Study Record Dates

• First Submitted: December 6, 2024
• First Posted: December 10, 2024
• Study Start: December 13, 2024
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: June 25, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)