Bioceramic Versus Epoxy Resin-Based Root Canal Sealer and Postoperative Pain After Warm Vertical Compaction
Comparison of the Effects of Epoxy Resin- and Bioceramic-Based Root Canal Sealers on Postoperative Pain in Root Canal Filling With Warm Vertical Compaction: A Randomized Clinical Trial
The goal of this clinical trial is to learn whether the type of root canal sealer affects pain after root canal treatment in adults aged 18 to 65 who need root canal treatment of a single-rooted upper front tooth with a non-vital (dead) pulp and no signs of infection around the root tip. The main questions it aims to answer are:
Does a bioceramic-based sealer (TotalFill BC Sealer HiFlow) cause a different level of pain after treatment than an epoxy resin-based sealer (AH Plus)? Does the need for pain medicine after treatment differ between the two sealers?
Researchers will compare the bioceramic-based sealer with the epoxy resin-based sealer, which is widely used as a standard reference material, to see if one causes less pain after the root canal is filled.
Participants will:
Receive root canal treatment of one tooth, filled with the warm vertical compaction technique using one of the two sealers, assigned by chance; participants will not know which sealer was used Rate their pain on a 0-100 scale at 6, 12, and 24 hours and on days 3, 5, and 7 after treatment Record whether and when they took pain medicine (paracetamol) Return for a check-up visit one week after treatment
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Background: Postoperative pain is a common complication of root canal treatment, and the chemical composition of the root canal sealer has been proposed as one of the factors influencing its incidence and intensity. Epoxy resin-based AH Plus is widely regarded as the reference sealer, whereas calcium silicate-based bioceramic sealers have gained popularity because of their biocompatibility, alkaline pH and hydraulic setting properties. Clinical evidence comparing these sealers in terms of postoperative pain remains inconsistent, and data obtained with warm vertical compaction are limited.
Design: This is a prospective, randomized, active-controlled, parallel-group, single-center clinical trial conducted at the Department of Endodontics, Faculty of Dentistry, Ataturk University (Erzurum, Turkey). Asymptomatic single-rooted maxillary anterior teeth with a diagnosis of pulp necrosis and normal apical tissues (periapical index score ≤2) will be included. A total of 70 participants (35 per group) will be allocated to one of two groups: Group 1, TotalFill BC Sealer HiFlow (FKG Dentaire SA, Switzerland); Group 2, AH Plus (Dentsply Sirona). Allocation will be performed using a computer-generated randomization sequence (www.randomizer.org). Participants will be blinded to group allocation; because pain will be self-reported by the participants, outcome assessment will also be blinded. Due to the different handling properties of the sealers, the operator cannot be blinded.
Treatment protocol: All treatments will be performed by a single operator following a standardized protocol. After local anesthesia and rubber dam isolation, the access cavity will be prepared and the working length determined with an electronic apex locator. Root canals will be shaped with a rotary instrumentation system and irrigated with 2.5% sodium hypochlorite, followed by a final rinse with distilled water. After drying, the assigned sealer will be applied and the canal obturated with the warm vertical compaction technique in both groups. Preoperative clinical and radiographic findings, including the periapical index (PAI) score, will be recorded on a standardized form.
Outcome assessment: Participants will rate their pain on a 100-mm Visual Analogue Scale (VAS) at 6, 12 and 24 hours and on days 3, 5 and 7 after treatment. Paracetamol 500 mg will be recommended as rescue medication, and analgesic intake (yes/no, day and time) will be recorded. Participants will be clinically re-examined one week after treatment for percussion and palpation sensitivity, swelling and sinus tract.
Statistical analysis: Normality will be tested with the Shapiro-Wilk test. Between-group comparisons will be performed with the independent-samples t-test or Mann-Whitney U test, and categorical variables with the chi-square or Fisher's exact test. Changes in pain over time will be analyzed with repeated-measures ANOVA or the Friedman test, as appropriate. The level of significance will be set at p<0.05.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Furkan Pala, DDS
- Telefonnummer: +905383369873
- E-Mail: furkanpala@atauni.edu.tr
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:- Age between 18 and 65 years
- Single-rooted permanent maxillary anterior tooth requiring root canal treatment
- Diagnosis of pulp necrosis with normal apical tissues (asymptomatic, no acute pain or abscess)
- Periapical index (PAI) score of 2 or lower
- Systemically healthy (ASA I) and not using any medication or analgesics
- Willing to participate and provided signed informed consent
Exclusion Criteria:- Systemic disease or pregnancy
- Use of analgesics or antibiotics within the previous 48 hours
- Symptomatic apical periodontitis, acute apical abscess, or teeth requiring retreatment
- Root resorption
- History of allergic reactions
- Abnormal root canal morphology (fused, dilacerated, or C-shaped canals)
- Periodontal pocket depth greater than 3 mm or tooth mobility
- Root perforation or instrument separation during treatment
- Loss of contact during the follow-up period
- Inability to complete the VAS pain scale according to the instructions
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Bioceramic Sealer Group
Root canal treatment completed in a single visit; root canal obturated with warm vertical compaction using gutta-percha and TotalFill BC Sealer HiFlow (FKG Dentaire SA, Switzerland). |
A premixed calcium silicate-based bioceramic root canal sealer applied with gutta-percha using the warm vertical compaction technique. |
|
Aktiver Komparator: Epoxy Resin Sealer Group
Root canal treatment completed in a single visit; root canal obturated with warm vertical compaction using gutta-percha and AH Plus (Dentsply Sirona). |
An epoxy resin-based root canal sealer applied with gutta-percha using the warm vertical compaction technique. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Postoperative Pain Intensity
Zeitfenster: 6, 12 and 24 hours and 3, 5 and 7 days after root canal obturation
|
Pain intensity after root canal treatment will be self-reported by participants on a 100-mm Visual Analogue Scale (VAS), where 0 indicates "no pain" and 100 indicates "unbearable/most severe pain". Higher scores indicate more severe pain. |
6, 12 and 24 hours and 3, 5 and 7 days after root canal obturation
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Analgesic Intake
Zeitfenster: Up to 7 days after root canal obturation
|
The number and proportion of participants who take rescue analgesic medication (paracetamol 500 mg) due to postoperative pain, together with the day and time of intake, will be recorded. |
Up to 7 days after root canal obturation
|
|
Clinical Signs at One-Week Recall
Zeitfenster: 7 days after root canal obturation
|
The presence of tenderness to percussion, tenderness to palpation, swelling and sinus tract will be clinically assessed and recorded as present or absent. |
7 days after root canal obturation
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Aziz Sahin Erdogan, DDS, PhD, Ataturk University
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- B.30.2.ATA.0.01.00/766
- 2025/4 (Andere Kennung: Ataturk University Clinical Research Ethics Committee)
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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