Do We Need to Prescribe Prophylactic Proton Pump Inhibitors Along With a Short Course of Non-Steroidal Anti-Inflammatory Drugs Following Dental Extraction: A Randomised Controlled Study
摘要
Non-steroidal anti-inflammatory drugs (NSAIDs) are routinely prescribed following dental extractions, often accompanied by a prophylactic proton pump inhibitor (PPI) for prevention of gastrointestinal (GI) side-effects. However, the necessity of such routine co-prescription in healthy individuals receiving short-term NSAIDs remains uncertain.
MethodsThis randomised, double-blind clinical study included 160 patients aged 18–60 years undergoing routine intra-alveolar dental extraction (IADE). Participants were allocated into two groups. Group A (NSAID + PPI) and Group B (NSAID - PPI). Both groups received a fixed-dose combination of Tab. Ibuprofen (400 mg) + Paracetamol (325 mg) for 3 days. Group A received Tab. Pantoprazole (40 mg) in addition to an NSAID for 3 days. GI symptoms-epigastric distress, acid reflux, and nausea were evaluated on post-operative day (POD) 3 and 7. Statistical analysis was conducted using SPSS v16, with significance set at p < 0.05.
ResultsNo statistically significant difference in the incidence of GI symptoms between the groups was noted. On POD 3, epigastric distress was observed in 1.2% of Group A and 2.5% of Group B (p = 0.560), acid reflux in 0% and 3.8% (p = 0.08), and nausea in 5.0% and 3.8% (p = 0.699), respectively. On POD 7, all symptoms had resolved or remained statistically insignificant.
ConclusionRoutine co-prescription of prophylactic PPI with short-term NSAID therapy following IADE may not be clinically warranted in healthy patients, potentially avoiding unnecessary medication and cost.
Practical ImplicationThe study highlights that short-term NSAID use after routine IADE may be safely prescribed without routine PPI co-administration in healthy individuals.
Open ScienceThe study protocol was prospectively registered with [CTRI Reg. Date - 18/06/2025, CTRI/2025/06/089077, https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=MTE4ODg1&Enc=54072.22503&userName=]. De-identified data and study materials are available upon reasonable request