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Clinical Trials/NCT06726837
NCT06726837CompletedNot Applicable

Effect of Continuous Wave of Condensation on Postoperative Pain Using Bioceramic Versus Resin Sealers: a Randomized Clinical Trial

Dicle University2 sites in 2 countries72 target enrollmentStarted: December 13, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
72
Locations
2
Primary Endpoint
Visual Analog Scale

Study Overview

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.

Detailed Description

A total of 72 participants who presented to the Department of Endodontics, Faculty of Dentistry, Dicle University, with the need for root canal treatment and met the predefined inclusion and exclusion criteria were included in this study. Root canal treatment was performed on single-rooted, single-canaled teeth. Prior to treatment, all participants were informed about the study and provided written informed consent. Following the administration of local anesthesia (2% lidocaine with 1:80,000 epinephrine), the tooth was isolated using a rubber dam, caries and existing restorations were removed with high-speed diamond burs under water cooling, and an access cavity was prepared. Pulp vitality was confirmed by observing bleeding from the canal orifice.

Working length was determined using a #15 K-file in conjunction with the integrated apex locator of the EndoRadar Pro motor and was radiographically confirmed at 0.5 mm short of the radiographic apex. Root canals were prepared using the T-Endo MUST (Dentac, Istanbul, Türkiye) reciprocating file system driven by the EndoRadar Pro motor. According to the initial apical diameter, canals were enlarged to sizes m25 (25/0.06), m40 (40/0.04), or m50 (50/0.04). A new file was used for each patient. Irrigation was performed using a 30-gauge side-vented closed-end irrigation needle positioned 2 mm short of the working length. During instrumentation, 2 mL of 2.5% sodium hypochlorite (NaOCl) was used after each file change, resulting in a total volume of approximately 20 mL per tooth. The final irrigation protocol consisted of 5 mL of 17% EDTA, 5 mL of 2.5% NaOCl, and 10 mL of distilled water. During final irrigation, both EDTA and NaOCl were activated using a sonic irrigation device with a polymer tip tip (Scope; Gtech Dizayn Dental, Yozgat, Türkiye) for a total of 1 minute, delivered in three 20-second activation cycles. The canals were subsequently dried with paper points. Patients were then randomly allocated into three groups according to the root canal sealer used (n = 24).

Group 1: AH Plus (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).

AH Plus was mixed according to the manufacturer's instructions and applied to the canal walls using the master gutta-percha cone. TotalFill BC Sealer and Bio-C Sealer were applied in their premixed forms by injection into the coronal third of the canal. Subsequently, all canals were obturated using the continuous wave of condensation technique (CWCT). All treatments, including post-endodontic restorations, were completed during the same visit. Patients were provided with a Visual Analog Scale (VAS) form and were instructed to record their pain intensity on a scale ranging from 0 to 10 at 6, 24, 48, and 72 hours, and 7 days after treatment. Analgesic intake was also recorded on the VAS form. Patients were recalled on the seventh day, and the completed VAS forms were collected. All data were entered into an Excel spreadsheet and analyzed.

Sample Size Calculation

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Masking Description

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.

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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)

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Visual Analog Scale

Time Frame: 6th hour, 24th hour, 48th hour, 72nd hour, 7th day

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Dicle University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Merve YENICERI OZATA

Associate Professor

Dicle University

Study Sites (2)

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