CompletedPhase 4

Assessment of Different Medications in Modifying the Efficacy of Anesthesia in Mandibular Molars With Acute Irreversible Pulpitis

Egypt60 participantsStarted 2024-09-15

Plain-language summary

The goal of this clinical trial is to assess the effect of preoperative * Oral Tablets of Trypsin/Chymotrypsin/Bromelain Limitless Allzyme® (15 microkatal/42microkatal/240 GDU) * Oral tablets of Alphintern® (Trypsin/Chymotrypsin 5 micro Katals/14 micro Katals) * Oral Tablets Non-Steroidal Anti-inflammatory drug (Cataflam® 50mg) Regarding the efficacy of the inferior alveolar nerve block anesthesia in mandibular molars with symptomatic irreversible pulpitis and post operative pain follow up for 3 days. The main question it aims to answer are: • Does premedication increase the success rate of inferior alveolar nerve block. Participants will describe their preoperative pain level to the investigator and describe their pain level during the treatment. Researchers will compare different premedication to see if it increases the success rate of inferior alveolar nerve block using Visual Analogue Scale (VAS), Electric Pulp testing and cavity test.

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: * • From 18 to 65 years old. * Both male and female participants were accepted. * Mandibular molars diagnosed with acute irreversible pulpitis. * Class I occlusion with normal occlusal contacts Exclusion Criteria: * • Individuals with significant health issues: a history of gastrointestinal disorders, active bronchial asthma, renal diseases, liver dysfunction, heart diseases, blood disorders, hypertension or poorly controlled diabetes mellitus. * Immunocompromised patients. * Sensitivity or allergy to any of the pharmaceuticals or medications intended for use in the study * Participants who could not read, comprehend, or complete the baseline pain scale questionnaire. * Cases where clinical examination suggested necrotic teeth leading to a false positive diagnosis. * Teeth exhibiting periodontal disease or periapical lesions confirmed through clinical assessment and pre-operative radiographs. * Sensitivity to percussion or palpation in the included 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

assess the effect of Preoperative administration of- Oral tablets of Trypsin/Chymotrypsin/Bromelain) - Regarding the efficacy of the inferior alveolar nerve block anesthesia in mandibular molars with symptomatic irreversible pulpitis

Timeframe: Up to 30 minutes from lip numbness until the end of pulp exacerbation and post operative pain follow up for 3 days.

Trial details

NCT IDNCT07088042

SponsorAin Shams University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-02-17

View on ClinicalTrials.gov More Pulpitis - Irreversible trials