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Postoperative Dental PainNCT06726837

Effect of Different Root Canal Sealers on Postoperative Pain

A study testing Postoperative pain - 6th hour, Postoperative pain - 24th hour and Postoperative pain - 48th hour in people with Postoperative Dental Pain and Root Canal Sealers, run by Dicle University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Postoperative pain - 6th hour, Postoperative pain - 24th hour and Postoperative pain - 48th hour
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteTurkey (Türkiye)
Study dates
13 Dec 2024to 31 Aug 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Dicle University, Faculty of Dentistry, Department of Endodontics

    Diyarbakır, 21010

Other trials in Turkey (Türkiye)

About this study

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

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.

Read more

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.

Read the 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

Sample size calculation was performed using G*Power software version 3.1.9.6. Based on data obtained from a previous study, a minimum of 20 patients per group was required to achieve an effect size of f = 0.412, a significance level of α = 0.05, and a statistical power of 95%. Considering a potential dropout rate of 20%, the final sample size was determined as 24 patients per group, resulting in a total sample of 72 participants.

Statistical Analysis

Statistical analyses were performed using IBM SPSS Statistics version 23.0 (IBM Corp., Armonk, NY, USA). The normality of data distribution was assessed prior to analysis. Categorical variables were analyzed using Fisher's Exact Test and Monte Carlo simulation. Changes in pain incidence over time were evaluated using Cochran's Q test. Binary logistic regression analysis was performed to determine the effects of independent variables, including age, sex, jaw, tooth region, and root canal sealer type, on the presence of postoperative pain. Statistical significance was set at P < 0.05.

Being tested
Postoperative pain - 6th hour, Postoperative pain - 24th hour, Postoperative pain - 48th hour, Postoperative pain - 72nd hour, Postoperative pain - 7 day
Keywords
Postoperative pain, Root canal sealers, Asymptomatic irreversible pulpitis, Visual analog scale, Warm obturation
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Postoperative pain - 6th hourOther

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

  • Postoperative pain - 24th hourOther

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

  • Postoperative pain - 48th hourOther

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

  • Postoperative pain - 72nd hourOther

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

  • Postoperative pain - 7 dayOther

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

Study groups in NCT06726837
Study groupRoleWhat they receive
Group 1: AH Plus Root Canal Sealer (Dentsply DeTrey, Konstanz, Germany)Active comparatorParticipants 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.
Receives: 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 comparatorAll 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.
Receives: 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 comparatorAll 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.
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (1)
  1. Postoperative pain incidence

    The presence or absence of postoperative pain was recorded at each follow-up time point.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2024
  2. Study start13 Dec 2024
  3. Primary completion31 Aug 2025
  4. Study completion31 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06726837
Sponsor's protocol ID
DUFD-END-MYO-01
Other IDs
DİŞ.24.013
Status last verified
Jun 2026
First submitted
6 Dec 2024
Last updated
25 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be made available.

Publications

  • 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.

    PubMed 36385378
  • 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.

    PubMed 32696911
  • Defiset M, Ozata MY. Effect of continuous wave of condensation on postoperative pain using bioceramic versus resin sealers: a randomized clinical trial. BMC Oral Health. 2026 Jul 9. doi: 10.1186/s12903-026-09200-x. Online ahead of print.

    PubMed 42426769

Questions about this trial

What is this clinical trial studying?

A study testing Postoperative pain - 6th hour, Postoperative pain - 24th hour and Postoperative pain - 48th hour in people with Postoperative Dental Pain and Root Canal Sealers, run by Dicle University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analog Scale (time frame: 6th hour, 24th hour, 48th hour, 72nd hour, 7th day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06726837, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.

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