RecruitingACTRN12626000147381

Do oral steroids or painkillersNon steriodal anti inflammatory drugs (NSAID’S) help dentists numb lower back teeth better in patients with severe toothache?

Comparing preoperative oral steroids to Non steriodal anti inflammatory drugs (NSAIDs)on anesthetic success of inferior alveolar nerve block in mandibular molars with symptomatic irreversible pulpitis

Sponsor

Dr Fawad Ali shah- Khyber college of dentistry

Enrollment

60 participants

Start Date

Jun 2, 2025

Study Type

Interventional

Conditions

Acute dental pain Symptomatic irreversible pulpitis of mandibular molars

Summary

Providing effective pulpal anesthesia in mandibular molars with symptomatic irreversible pulpitis (SIP) remains a clinical challenge due to high failure rates of inferior alveolar nerve block (IANB). Inflammation-induced sensitization of peripheral nociceptors is considered a key factor reducing anesthetic success in such cases. Various adjunctive techniques and premedications have been explored to improve outcomes, including NSAIDs, steroids, and other agents. Dexamethasone and ketorolac, through their anti-inflammatory mechanisms, may enhance anesthetic efficacy when administered orally before IANB. This study aims to compare the effectiveness of preoperative oral dexamethasone (4 mg) and ketorolac (10 mg) in improving IANB success in mandibular molars with SIP.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 60 Yearss

Plain Language Summary

Simplified for easier understanding

Getting a tooth properly numb before dental treatment can be surprisingly difficult — especially for lower back teeth (mandibular molars) that are severely inflamed and painful. This condition is called symptomatic irreversible pulpitis, and it means the nerve inside the tooth is damaged and inflamed beyond repair, requiring root canal treatment. Inflammation chemically changes the nerve, making local anaesthetic injections less effective. This study is testing whether taking an anti-inflammatory or pain-relief tablet before dental treatment — either dexamethasone (a steroid) or ketorolac (a strong anti-inflammatory painkiller) — can improve how well the dental nerve block works. The goal is to make dental procedures more comfortable for patients experiencing severe toothache. You may be eligible if you are between 18 and 60 years old, are generally healthy (no serious systemic conditions), and have been diagnosed with irreversible pulpitis in a lower back tooth. People who are pregnant, have allergies to the study medications, have compromised immune systems, or have taken analgesics or antibiotics recently would not be able to participate.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Participants will be consecutively recruited and allocated into intervention groups using a non-randomised, consecutive allocation method determined by investigator discretion. 1. Dexamethasone grou

Participants will be consecutively recruited and allocated into intervention groups using a non-randomised, consecutive allocation method determined by investigator discretion. 1. Dexamethasone group (Dexa group): Participants will receive a single oral dose of dexamethasone 4 mg, concealed in a coded container, administered one hour before the procedure. 2. Ketorolac group (Keto group): Participants will receive a single oral dose of ketorolac 10 mg, concealed in a coded container, administered one hour before the procedure. The assigned medication will be administered one hour prior to the inferior alveolar nerve block (IANB) procedure. One hour after drug intake, local anesthesia containing 2% lidocaine will be administered using the standard IANB technique. Participants will be asked to report the onset of lip numbness. Pulpal anesthesia will be assessed using electric pulp testing (EPT) at 10 minutes and 15 minutes post-anesthesia. Two consecutive negative EPT responses will confirm pulpal anesthesia. Endodontic access cavity preparation will then be initiated under rubber dam isolation. The presence or absence of pain during access or instrumentation will be recorded. Anesthetic success will be defined as absence of pain during the procedure.

Locations(1)

Peshawar, Khyber Pakhtunkhwa, Pakistan

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ACTRN12626000147381