CompletedNot Applicable

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

Turkey (Türkiye)70 participantsStarted 2025-03-12

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Postoperative Pain Level

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

Trial details

NCT IDNCT07289633

SponsorAZİZ ŞAHİN ERDOĞAN

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-25

View on ClinicalTrials.gov More Asymptomatic Apical Periodontitis trials