CompletedNot Applicable

The Effect of Two Different Root Canal Sealers on Postobturation Pain and Clinical and Radiographical Outcome After Two-year Follow-up

Turkey (Türkiye)100 participantsStarted 2019-11-20

Plain-language summary

Post-obturation pain evaluation(Part 1): One hundred asymptomatic mandibular molar teeth with vital pulp were randomly assigned into two groups according to the sealer used MTA Fillapex (Angelus Odontologica Industries SA, Londrina, PR, Brazil) or AH Plus (Dentsply Sirona, Ballaigues, Switzerland) sealer. WaveOne Gold instruments were used for root canal preparations in both groups. Root canals were obturated with the manufacturer advised own gutta-percha points of preparation technique and MTA Fillapex was used in the first group and AH Plus was used in the second group as a root canal sealer. Postoperative pain at 6, 12, 24, 48, 72 hours, 4, 5, 6, 7, and 30 days after root canal treatment was measured with the Numerical Rating Scale (NRS), and patients were informed to record the number of analgesics they used during these time periods. Clinical and radiological outcome evaluation(Part 2): Patients were recalled for clinical and radiographic examinations at 12 and 24 months postoperatively. The clinical outcome was determined as success or failure according to objective evaluation of symptoms of inflammation or infection. In clinical examination at follow-up appointments, swelling, pain, sinus tract, tenderness to percussion, and/or palpation test, periodontal probing depths were determined and recorded. The radiographic outcome was evaluated and classified according to the Strindberg criteria. Teeth with a normal contour, width, and structure of the periodontal ligament were considered as"successful" and teeth with a widened periodontal contours or a new periapical radiolucency were considered as "failed". Additionally, the other parameters (age, gender, tooth number, apical gutta level) on treatment success were examined.

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 older than 18 years * Good oral hygiene * Patients with mature mandibular first or second molars diagnosed with asymptomatic irreversible pulpitis due to deep caries * Teeth that have not been treated endodontically and restoratively before * A delayed positive response to cold test and electric pulp tests in the vitality test of the teeth * Large pulpal perforation during caries removal * Presence of thick and profuse pulpal bleeding could not be controlled within 5 minutes * Absence of periapical pathology of teeth when confirmed with periapical radiographically Exclusion Criteria: * Patients who refused to participate in the study * The patients are not systemically healthy, allergic to the materials and agents used during root canal treatment * Having a history of sensitivity to local anesthetics. * Patients who used antibiotics and analgesics in the 7 days prior to the beginning of treatment. * Symptomatic or non-vital teeth * Patients have more than one tooth requiring endodontic treatment * Teeth with material loss that cannot be restored, or teeth that require a post or that will be used as a supporting tooth for a prosthesis * The presence of advanced periodontal disease (probing depth \>3 mm) * Presence of calcified root canal, presence of internal or external root resorption * Second molars with C-shaped root canal anatomy

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

The incidence and intensity of post-obturation pain

Timeframe: up to 30-day

Trial details

NCT IDNCT05266599

SponsorEge University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-02-07

View on ClinicalTrials.gov More Asymptomatic Vital Mandibular Molar Teeth trials