CompletedPhase 4

Enhancing Anaesthetic Success in Mandibular Molars With Symptomatic Irreversible Pulpitis: A Comparative Randomized Controlled Trial

Egypt188 participantsStarted 2023-02-01

Plain-language summary

The goal of this clinical trial is to assess the effect of * Preoperative intraligamentary corticosteroids injection * Cryotherapy which is cold application on : * Hard tooth structure ( crown of the tooth ) * Soft tissue overlying roots on the efficacy of the inferior alveolar nerve block anaesthesia in patients with mandibular molars with symptomatic irreversible pulpitis. The main question it aims to answer are: • Does intraligamentary dexamethazone injection increase the success rate of inferior alveolar nerve block without the need for oral premedication. Participants will describe their preoperative pain level to the investigator and describe their pain level during the treatment. Researchers will compare cryotherapy to see if it increases the success rate of inferior alveolar nerve block.

Who can participate

Age range

25 Years – 40 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: * Participants willing to commit for the entire period of the trial and agreed to sign the written consent after full explanation of the study. * Having a mandibular molar tooth diagnosed with symptomatic irreversible pulpitis (hot tooth - vital pulp, intermittent or continuous sharp pain that lasts longer after removal of the stimulus). Exclusion Criteria: * Presence of any systemic disease or allergic reactions. * Vulnerable group; prisoners, pregnant females, mentally ill, etc… * The presence of a periapical radiolucency. * Teeth with open apices. * A previous root canal treatment. * Sinus tracts. * Local gum swelling around the affected tooth. * Severe periodontal disease . * Presence of periodontal pockets \>3 mm in the affected tooth. * Absence of bleeding in the pulp chamber on access cavity preparation. * Patients with doubted diagnosis due to multiple carious teeth.

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 effect of intraligamentary dexamethazone injection on the success rate of inferior alveolar nerve block

Timeframe: Assessed up to 30 minutes, from lip numbness point until the end of pulp extirpation.

Trial details

NCT IDNCT06330519

SponsorAin Shams University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-03-01

View on ClinicalTrials.gov More Pulpitis - Irreversible trials