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

NCT ID: NCT07289633

Last Updated: 2025-12-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-12
• Study Completion Date: 2025-10-02

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.

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.

Conditions

Asymptomatic Apical Periodontitis

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

BioRoot RCS Group

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

Group Type: EXPERIMENTAL

BioRoot RCS

Intervention Type: 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 Group

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

Group Type: ACTIVE_COMPARATOR

AH Plus

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AZİZ ŞAHİN ERDOĞAN

OTHER

Sponsor Role: lead

Responsible Party

AZİZ ŞAHİN ERDOĞAN

Assistant Professor of Endodontics

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Atatürk University Faculty of Dentistry

Erzurum, palandöken, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

B.30.2ATA.0.01.00/559

Identifier Type: -

Identifier Source: org_study_id