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

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

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.

Study Overview

• Status: Completed
• Conditions: Asymptomatic Apical Periodontitis
• Intervention / Treatment: Other: BioRoot RCS; Other: AH Plus

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • palandöken
    • Erzurum, palandöken, Turkey (Türkiye), 25100
      • Atatürk University Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BioRoot RCS Group; Single-visit root canal treatment using BioRoot RCS (bioceramic sealer)	Other: BioRoot RCS; 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.
Active Comparator: AH Plus Group; Single-visit root canal treatment using AH Plus (resin-based sealer)	Other: AH Plus; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Pain Level	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.	First 7 days after treatment (24 hours, 48 hours, 72 hours, and 7 days)

Collaborators and Investigators

• Sponsor: AZİZ ŞAHİN ERDOĞAN

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2025
• Primary Completion (Actual): September 25, 2025
• Study Completion (Actual): October 2, 2025

Study Registration Dates

• First Submitted: December 2, 2025
• First Submitted That Met QC Criteria: December 15, 2025
• First Posted (Actual): December 17, 2025

Study Record Updates

• Last Update Posted (Actual): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Postoperative Pain; Root Canal Treatment; AH Plus; BioRoot RCS; Mandibular Molars
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; epoxy resin-based root canal sealer
• Other Study ID Numbers: B.30.2ATA.0.01.00/559

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No