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NCT Number: NCT07289633

Evaluation of Postoperative Pain After Using Resin-Based and Bioceramic Sealers in Mandibular Molars With Asymptomatic Apical Periodontitis

This study aims to evaluate the effect of two different root canal sealers-BioRoot RCS (a bioceramic-based sealer) and AH Plus (a resin-based sealer)-on postoperative pain following single-visit root canal treatment in mandibular first and second molars diagnosed with asymptomatic apical periodontitis. Postoperative pain levels will be assessed at multiple time intervals to determine whether the type of canal sealer influences patient discomfort after treatment.

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Key information

Conditions

Asymptomatic Apical Periodontitis Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atatürk University Faculty of Dentistry

Erzurum, palandöken, 25100, Turkey (Türkiye)

About this study

Asymptomatic apical periodontitis is a common condition requiring root canal treatment, and postoperative pain is an important outcome that affects patient comfort and clinical decision-making. Root canal sealers play a critical role in the success of endodontic therapy, and their physical and biological properties may influence postoperative symptoms.

This study compares a bioceramic-based sealer (BioRoot RCS) and a resin-based sealer (AH Plus) in patients receiving single-visit root canal treatment for mandibular first and second molars with asymptomatic apical periodontitis. Participants will be randomly assigned to one of the two sealer groups. Pain intensity will be recorded using a validated pain scale at predetermined time intervals following treatment. The findings of this study may help clinicians select sealers based on their impact on postoperative pain and improve patient outcomes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged 18 years or older with adequate oral hygiene.
  • Teeth with no previous endodontic or restorative treatment.
  • Teeth that do not respond to cold test and electric pulp test during vitality assessment.
  • Teeth that are asymptomatic prior to treatment.
  • Mandibular first or second molar teeth with complete root development.
  • No bleeding observed in the pulp chamber after caries removal.
  • Teeth with a Periapical Index (PAI) score of 3 or less.
  • Patients who have not used antibiotics within the last 1 month.
  • Patients who have not used analgesics within the last 72 hours.

Exclusion criteria

  • Presence of systemic diseases that may affect healing (e.g., uncontrolled diabetes, immunosuppression).
  • Pregnancy or breastfeeding.
  • Teeth with a history of trauma, resorption, or previous endodontic access.
  • Teeth with root canal calcifications or anatomical abnormalities preventing standard instrumentation.
  • Presence of sinus tract, swelling, or acute apical abscess.
  • Teeth with a Periapical Index (PAI) score greater than 3.
  • Patients taking medications that may alter pain perception (e.g., corticosteroids, neuropathic pain medications).
  • Patients unable to comply with follow-up pain recordings.
  • Patients with known allergy to any materials used in the study (e.g., sodium hypochlorite, sealers).

Treatment and study plan

BioRoot RCS

Other

Single-visit root canal treatment was performed on mandibular molar teeth diagnosed with asymptomatic apical periodontitis. After shaping and irrigation, the canals were obturated using the BioRoot RCS bioceramic-based sealer with a single-cone technique. No additional medicament or adjunctive procedure was used.

AH Plus

Other

Single-visit root canal treatment was performed on mandibular molar teeth diagnosed with asymptomatic apical periodontitis. After shaping and irrigation, the canals were obturated using the AH Plus resin-based sealer with a single-cone technique. No additional medicament or adjunctive procedure was used.

Primary outcomes

  1. Postoperative Pain Level

    Time frame: First 7 days after treatment (24 hours, 48 hours, 72 hours, and 7 days)

    Postoperative pain will be recorded using a 10-cm Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Participants will report their pain levels at 24 hours post-treatment, 48 hours post-treatment, 72 hours post-treatment, and on 7 days post-treatment following single-visit root canal treatment.

Sponsors and collaborators

Lead sponsor

AZİZ ŞAHİN ERDOĞAN

Other

Registry information

Official study title

Evaluation of the Effect of Resin-Based and Bioceramic Sealers on Postoperative Pain in Mandibular Molars With Asymptomatic Apical Periodontitis Treated in a Single Visit

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 17, 2025
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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