Evaluating the Combined Effect of Oral Premedications on Inferior Alveolar Nerve Block Effectiveness (NCT07146997) | Clinical Trial Compass
CompletedPhase 3
Evaluating the Combined Effect of Oral Premedications on Inferior Alveolar Nerve Block Effectiveness
Pakistan96 participantsStarted 2023-11-23
Plain-language summary
This clinical study investigates whether the combination of ibuprofen and serratiopeptidase as oral premedication can enhance the effectiveness of the inferior alveolar nerve block (IANB) in patients with symptomatic irreversible pulpitis in mandibular teeth. Due to the inflammatory nature of the condition, standard IANB often fails, possibly due to prostaglandin-induced nerve sensitization.
A total of 96 patients meeting specific inclusion criteria will be divided into four groups:
Placebo
Ibuprofen alone
Serratiopeptidase alone
Combination of ibuprofen and serratiopeptidase
Pain levels will be measured using the Verbal Numerical Scale (VNS) at various treatment stages. The success of anesthesia will be determined by the absence or presence of pain during access cavity preparation and initial root canal instrumentation. Statistical analysis will compare the effectiveness between groups, with the goal of determining whether combined premedication significantly improves IANB success.
The study is conducted at the Department of Operative Dentistry \& Endodontics, HITEC-IMS Taxila, over a period of six months.
Who can participate
Age range
18 Years – 45 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:
* Age group of subjects between 18-45 years
* Normal PDL appearance on IOPA
* No analgesics taken 12 hours prior to study
* Mandibular molars and premolars with deep carious lesion having sign and symptom of symptomatic irreversible pulpitis
* Exclusion criteria:
* Presence of periapical radiolucency on IOPA
* Teeth tender to percussion /traumatic teeth
* Allergy to medications/anesthetic solution
* Pregnant patient \& systemic illness
* Patient in which local anesthesia is not effective in first attempt
* Patient not giving consent
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
1
Effectiveness of Inferior Alveolar Nerve Block (IANB