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

NCT07289633 | Completed

• 1 other identifier: B.30.2ATA.0.01.00/559
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Asymptomatic Apical Periodontitis

Keywords

Root Canal Treatment; Postoperative Pain; BioRoot RCS; AH Plus; Mandibular Molars

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

BioRoot RCS Group

EXPERIMENTAL

Single-visit root canal treatment using BioRoot RCS (bioceramic sealer)

Other: BioRoot RCS

AH Plus Group

ACTIVE COMPARATOR

Single-visit root canal treatment using AH Plus (resin-based sealer)

Other: AH Plus

Interventions

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.

BioRoot RCS Group

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.

AH Plus Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• AZİZ ŞAHİN ERDOĞAN: lead

Study Sites (1)

Atatürk University Faculty of Dentistry

Erzurum, palandöken, 25100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

epoxy resin-based root canal sealer

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: his study uses a single-blind masking design. Participants are blinded to the type of root canal sealer used during treatment, but the care provider performing the procedure is not blinded. Postoperative pain is self-reported by participants using a standardized pain scale.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Endodontics

Model Details: This study uses a parallel assignment model in which participants are randomly allocated to one of two treatment groups receiving either a bioceramic-based sealer (BioRoot RCS) or a resin-based sealer (AH Plus) during single-visit root canal treatment.

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: December 17, 2025
• Study Start: March 12, 2025
• Primary Completion: September 25, 2025
• Study Completion: October 2, 2025
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)